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AMAG Pharmaceuticals, Inc. related to the commercialization of MuGard® in the US and its territories. For more information on MuGard®, US visitors to this website should select the MuGard.com button, below. Non-US visitors should select the right-hand button:
MuGard.com§
MuGard.com
For US residents
For non US-residents
Access is focusing its development effort on its Cobalamin™ technology. Cobalamin™ is Access' proprietary nanopolymer oral drug delivery technology. Using a 'Trojan Horse' approach, the technology uses the body's natural vitamin B12 uptake mechanism in the gut to transport drugs that otherwise would have little or no oral bioavailability. The company is currently developing products for the oral delivery of insulin and human growth hormone (HGH), and is collaborating with a number of companies to develop additional formulations of various other pharmaceutically-active compounds. Cells involved in certain diseases such as cancer often have an increased demand for vitamin B12 which results in a large increase in receptors for vitamin B12 on their surface. Another aspect of the Cobalamin™ technology therefore focuses on increasing the amount of drugs reaching sites of disease by making use of this higher receptor density. Application of the Cobalamin™ technology to enhance oral drug delivery has been named CobOral®, while application of the technology to target disease sites has been named CobaCyte®.www.accesspharma.com/
MuGard.com§
MuGard.com
For US residents
For non US-residents
Access is focusing its development effort on its Cobalamin™ technology. Cobalamin™ is Access' proprietary nanopolymer oral drug delivery technology. Using a 'Trojan Horse' approach, the technology uses the body's natural vitamin B12 uptake mechanism in the gut to transport drugs that otherwise would have little or no oral bioavailability. The company is currently developing products for the oral delivery of insulin and human growth hormone (HGH), and is collaborating with a number of companies to develop additional formulations of various other pharmaceutically-active compounds. Cells involved in certain diseases such as cancer often have an increased demand for vitamin B12 which results in a large increase in receptors for vitamin B12 on their surface. Another aspect of the Cobalamin™ technology therefore focuses on increasing the amount of drugs reaching sites of disease by making use of this higher receptor density. Application of the Cobalamin™ technology to enhance oral drug delivery has been named CobOral®, while application of the technology to target disease sites has been named CobaCyte®.www.accesspharma.com/
Corporate Governance
Audit Committee Charter
Code of Ethics
Nominating and Corporate Governance Committee Charter
Compensation Committee Charter
Corporate Governance Committee Charter
Whistleblower Policy
Downloads
2013 Proxy Statement
2013 Annual Report
ACCP Corporate Presentation
Cobalamin™ Fact Sheet
www.accesspharma.com/investor-relations/
Audit Committee Charter
Code of Ethics
Nominating and Corporate Governance Committee Charter
Compensation Committee Charter
Corporate Governance Committee Charter
Whistleblower Policy
Downloads
2013 Proxy Statement
2013 Annual Report
ACCP Corporate Presentation
Cobalamin™ Fact Sheet
www.accesspharma.com/investor-relations/
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ACCPLast Trade0.38Change-0.0001 Open0.39BidN/AAskN/AVolume11503
www.accesspharma.com/investor-relations/sec-filings/
www.accesspharma.com/investor-relations/sec-filings/
biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients.www.accesspharma.com/newsroom/
www.accesspharma.com/investor-relations/sec-filings/ GrB
2600 Stemmons Freeway,
Suite 176
Dallas, TX 75207-2107
Tel: (214) 905-5100
info@accesspharma.com
@Kosmonova buran,ISS Orbit
Suite 176
Dallas, TX 75207-2107
Tel: (214) 905-5100
info@accesspharma.com
@Kosmonova buran,ISS Orbit
Of MuGard Clinical Data In Cancer Journal14:36 18.02.14
PR Newswire
NEW YORK, Feb. 18, 2014
NEW YORK, Feb. 18, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) announced the online early publication of the final results of its post-approval marketing study of MuGard® in Cancer, the journal of the American Cancer Society and one of the oldest peer-reviewed journals in oncology. The publication, entitled "Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and Neck," is available at onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full. The publication discusses data on Access' post-marketing clinical trial that evaluated the efficacy of MuGard in controlling symptoms caused by oral mucositis in 120 patients receiving chemoradiation therapy for the treatment of cancers of the head and neck.
MuGard was shown to be superior to the sham control saline-bicarbonate rinse in mitigating oral mucositis symptoms and delaying oral mucositis progression. In the trial, MuGard met the primary endpoint, achieving a statistically significant reduction in mouth and throat soreness associated with oral mucositis. MuGard also achieved significance in a secondary endpoint, the measure of mucositis severity at the end of radiation treatment using a physician-based assessment of severity (WHO score). Additional secondary endpoints where MuGard demonstrated superiority were reduced opioid use and weight loss.
"Oral mucositis is one of the most challenging adverse side-effects we face when treating our cancer patients," stated Dr. Ron R. Allison of Carolina Radiation Medicine, Greenville, NC. Dr. Allison, a principal investigator in the MuGard trial, continued "From a patient quality-of-life perspective, the reduction in mouth-and-throat soreness and reduced dependence upon opioids are extremely important. Patients using MuGard showed better weight maintenance, indicative of a superior nutritional status during the intensive cancer treatment regimen. As a physician, I was particularly impressed by the fact that the reduction of oral mucositis severity and mouth-and-throat soreness in the MuGard group was statistically significant."
"Oral mucositis continues to be a significant unmet medical need with horrific symptomatic consequences. This multi-institutional study provides strong evidence of MuGard's effectiveness in reducing pain associated with radiation-induced injury," stated Stephen T. Sonis, DMD, DMSc, an expert on cancer treatment complications, Clinical Professor of Oral Medicine at Harvard and the primary author of the protocol for this trial. "Access' commitment to demonstrate MuGard's benefit through a rigorous clinical trial process separates MuGard from currently available rinses and sets a new standard for evidence-based use of agents in this class."
No difference in adverse events was observed between patients receiving MuGard and those patients receiving the saline-bicarbonate control. No patients discontinued MuGard treatment because of an adverse event while two patients using the sham-control ended their medication use due to nausea or vomiting.
"Access is extremely pleased with the outcome and publication of this clinical study of MuGard, and thank the many participating clinicians, sites and authors for the participation in this important trial," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "Raising the level of visibility for MuGard should expand its usage, and availability, both domestically and abroad. Access is actively seeking additional marketing agreements in Europe, the Far East and in other un-licensed territories and will keep all stakeholders apprised as to developments in this area."
About Oral Mucositis: Oral mucositis ("OM") is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. There are an estimated 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard was launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Scott Nogi
Vice President
Access Pharmaceuticals, Inc.
(212) 786-6203
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
PR Newswire
NEW YORK, Feb. 18, 2014
NEW YORK, Feb. 18, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) announced the online early publication of the final results of its post-approval marketing study of MuGard® in Cancer, the journal of the American Cancer Society and one of the oldest peer-reviewed journals in oncology. The publication, entitled "Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and Neck," is available at onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full. The publication discusses data on Access' post-marketing clinical trial that evaluated the efficacy of MuGard in controlling symptoms caused by oral mucositis in 120 patients receiving chemoradiation therapy for the treatment of cancers of the head and neck.
MuGard was shown to be superior to the sham control saline-bicarbonate rinse in mitigating oral mucositis symptoms and delaying oral mucositis progression. In the trial, MuGard met the primary endpoint, achieving a statistically significant reduction in mouth and throat soreness associated with oral mucositis. MuGard also achieved significance in a secondary endpoint, the measure of mucositis severity at the end of radiation treatment using a physician-based assessment of severity (WHO score). Additional secondary endpoints where MuGard demonstrated superiority were reduced opioid use and weight loss.
"Oral mucositis is one of the most challenging adverse side-effects we face when treating our cancer patients," stated Dr. Ron R. Allison of Carolina Radiation Medicine, Greenville, NC. Dr. Allison, a principal investigator in the MuGard trial, continued "From a patient quality-of-life perspective, the reduction in mouth-and-throat soreness and reduced dependence upon opioids are extremely important. Patients using MuGard showed better weight maintenance, indicative of a superior nutritional status during the intensive cancer treatment regimen. As a physician, I was particularly impressed by the fact that the reduction of oral mucositis severity and mouth-and-throat soreness in the MuGard group was statistically significant."
"Oral mucositis continues to be a significant unmet medical need with horrific symptomatic consequences. This multi-institutional study provides strong evidence of MuGard's effectiveness in reducing pain associated with radiation-induced injury," stated Stephen T. Sonis, DMD, DMSc, an expert on cancer treatment complications, Clinical Professor of Oral Medicine at Harvard and the primary author of the protocol for this trial. "Access' commitment to demonstrate MuGard's benefit through a rigorous clinical trial process separates MuGard from currently available rinses and sets a new standard for evidence-based use of agents in this class."
No difference in adverse events was observed between patients receiving MuGard and those patients receiving the saline-bicarbonate control. No patients discontinued MuGard treatment because of an adverse event while two patients using the sham-control ended their medication use due to nausea or vomiting.
"Access is extremely pleased with the outcome and publication of this clinical study of MuGard, and thank the many participating clinicians, sites and authors for the participation in this important trial," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "Raising the level of visibility for MuGard should expand its usage, and availability, both domestically and abroad. Access is actively seeking additional marketing agreements in Europe, the Far East and in other un-licensed territories and will keep all stakeholders apprised as to developments in this area."
About Oral Mucositis: Oral mucositis ("OM") is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. There are an estimated 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard was launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Scott Nogi
Vice President
Access Pharmaceuticals, Inc.
(212) 786-6203
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
Agreement With Hanmi Pharmaceutical In Korea13:55 11.03.14
PR Newswire
NEW YORK, March 11, 2014
NEW YORK, March 11, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) today announced that it had entered into an exclusive license agreement with HANMI PHARMACEUTICAL CO., LTD. (KSE: 128940) related to MuGard commercialization in South Korea. Under the terms of the license agreement, Access will receive an upfront licensing fee and double digit royalties on net sales of MuGard in the licensed territory. MuGard is an oral mucoadhesive that is designed to manage oral mucositis by forming a protective hydrogel coating over the oral mucosa to shield the membranes of the mouth and tongue. Oral mucositis is a common side effect of cancer treatments, with approximately 400,000 patients in the US alone developing the condition each year.
"Access is pleased to announce this partnership with Hanmi Pharmaceuticals, a leader in Korea, as we believe that international expansion and licensing is critical to the commercial success of MuGard," said Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "Hanmi's international presence, resources and strategic emphasis on expansion makes them an ideal partner for MuGard. With the recent publication of MuGard clinical data, completion of this third marketing partnership, and active discussions with additional partnerships abroad, Access is laying the foundation for MuGard growth globally."
Access recently announced publication of positive MuGard clinical data in Cancer, the journal of the American Cancer Society. The publication, entitled "Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and Neck," is available at onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
About Oral Mucositis: Oral mucositis ("OM") is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. There are an estimated 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard was launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States.
About Hanmi: Established in 1973, Hanmi Pharmaceutical dedicates over 15% of its annual revenue into research and development on novel drug discovery and incrementally modified drugs. Hanmi transferred its technology to Roche and Novartis in what was Korea's first and largest scale in drug technology export. Hanmi further raised its global profile and recognition as the pharmaceutical leader of South Korea following its export license and agreement with Merck on Hanmi's fixed dose hypertension drug Amosartan. Beginning with the establishment of Beijing Hanmi Pharmaceutical Co., Ltd in domestic China, Hanmi is expanding its global presence into major markets such as Japan, Europe and USA. For more information, please visit www.hanmipharm.com/eng/.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timeliness and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Christine Berni
Access Pharmaceuticals, Inc.
(212) 786-6208
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
PR Newswire
NEW YORK, March 11, 2014
NEW YORK, March 11, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) today announced that it had entered into an exclusive license agreement with HANMI PHARMACEUTICAL CO., LTD. (KSE: 128940) related to MuGard commercialization in South Korea. Under the terms of the license agreement, Access will receive an upfront licensing fee and double digit royalties on net sales of MuGard in the licensed territory. MuGard is an oral mucoadhesive that is designed to manage oral mucositis by forming a protective hydrogel coating over the oral mucosa to shield the membranes of the mouth and tongue. Oral mucositis is a common side effect of cancer treatments, with approximately 400,000 patients in the US alone developing the condition each year.
"Access is pleased to announce this partnership with Hanmi Pharmaceuticals, a leader in Korea, as we believe that international expansion and licensing is critical to the commercial success of MuGard," said Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "Hanmi's international presence, resources and strategic emphasis on expansion makes them an ideal partner for MuGard. With the recent publication of MuGard clinical data, completion of this third marketing partnership, and active discussions with additional partnerships abroad, Access is laying the foundation for MuGard growth globally."
Access recently announced publication of positive MuGard clinical data in Cancer, the journal of the American Cancer Society. The publication, entitled "Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and Neck," is available at onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
About Oral Mucositis: Oral mucositis ("OM") is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. There are an estimated 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard was launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States.
About Hanmi: Established in 1973, Hanmi Pharmaceutical dedicates over 15% of its annual revenue into research and development on novel drug discovery and incrementally modified drugs. Hanmi transferred its technology to Roche and Novartis in what was Korea's first and largest scale in drug technology export. Hanmi further raised its global profile and recognition as the pharmaceutical leader of South Korea following its export license and agreement with Merck on Hanmi's fixed dose hypertension drug Amosartan. Beginning with the establishment of Beijing Hanmi Pharmaceutical Co., Ltd in domestic China, Hanmi is expanding its global presence into major markets such as Japan, Europe and USA. For more information, please visit www.hanmipharm.com/eng/.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timeliness and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Christine Berni
Access Pharmaceuticals, Inc.
(212) 786-6208
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
Access Pharmaceuticals Advances Development of ProctiGard™ for Radiation Proctitis
13:35 21.03.14
PR Newswire
NEW YORK, March 21, 2014
NEW YORK, March 21, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) announced that it has advanced development of a new proprietary product, called ProctiGard™, for the treatment of radiation proctitis. Radiation proctitis ("RP") is a significant unmet medical need, with no well-established standard of care. It is estimated that there are in excess of 250,000 new cases of prostate, cervical, rectal, testicular, bladder and endometrial cancer diagnosed each year. Approximately 50% of these patients require radiation therapy, and roughly 75% of patients undergoing pelvic irradiation experience radiation proctitis. Access is actively seeking marketing partners globally for ProctiGard™.
"Access is actively developing follow-on products to MuGard® that leverage our powerful mucoadhesive polymer hydrogel drug delivery technology, and ProctiGard™ is the first example of this development effort," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "Radiation proctitis is a condition somewhat analogous to oral mucositis, concerning the damage and ulceration of the mucosal tissue of the digestive tract. The development of ProctiGard™ is a direct response to dialogue with the oncology community that is looking for better, more effective treatment options for this debilitating oncology side effect."
Davis continued, "Access intends to follow the MuGard® development and commercialization strategy with ProctiGard™ by progressing manufacturing scale-up, the signing of multiple commercialization partners here in the US and abroad, and the completion and successful publication of supportive, positive clinical data similar to the recently published MuGard® clinical trial data in Cancer."
About Radiation Proctitis: Radiation proctitis is the inflammation and damage to the lower portion of the colon, primarily the sigmoid colon and rectum, after exposure to x-rays or ionizing radiation as part of radiation therapy. RP is most common after treatments for cancer, such as cervical, colon, and prostate cancer. RP can be acute, occurring within weeks of initiation of therapy, or can occur months or years after treatment, and symptoms include diarrhea, nausea, cramps, urgency, mucus discharge and painful defecation. Experts believe that RP occurs due to damage to the blood vessels that occurs as part of the radiation therapy.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard was launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States, RHEI Pharmaceuticals in China, and Hanmi Pharmaceuticals in Korea. Clinical data on MuGard®, entitled "Multi-Institutional, Randomized, Double Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptom in Patients being treated With Chemoradiation Therapy for Cancers of the Head and Neck," was recently published online at onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products including ProctiGard™. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Scott Nogi
Vice President
Access Pharmaceuticals, Inc.
(212) 786-6203
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
13:35 21.03.14
PR Newswire
NEW YORK, March 21, 2014
NEW YORK, March 21, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) announced that it has advanced development of a new proprietary product, called ProctiGard™, for the treatment of radiation proctitis. Radiation proctitis ("RP") is a significant unmet medical need, with no well-established standard of care. It is estimated that there are in excess of 250,000 new cases of prostate, cervical, rectal, testicular, bladder and endometrial cancer diagnosed each year. Approximately 50% of these patients require radiation therapy, and roughly 75% of patients undergoing pelvic irradiation experience radiation proctitis. Access is actively seeking marketing partners globally for ProctiGard™.
"Access is actively developing follow-on products to MuGard® that leverage our powerful mucoadhesive polymer hydrogel drug delivery technology, and ProctiGard™ is the first example of this development effort," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "Radiation proctitis is a condition somewhat analogous to oral mucositis, concerning the damage and ulceration of the mucosal tissue of the digestive tract. The development of ProctiGard™ is a direct response to dialogue with the oncology community that is looking for better, more effective treatment options for this debilitating oncology side effect."
Davis continued, "Access intends to follow the MuGard® development and commercialization strategy with ProctiGard™ by progressing manufacturing scale-up, the signing of multiple commercialization partners here in the US and abroad, and the completion and successful publication of supportive, positive clinical data similar to the recently published MuGard® clinical trial data in Cancer."
About Radiation Proctitis: Radiation proctitis is the inflammation and damage to the lower portion of the colon, primarily the sigmoid colon and rectum, after exposure to x-rays or ionizing radiation as part of radiation therapy. RP is most common after treatments for cancer, such as cervical, colon, and prostate cancer. RP can be acute, occurring within weeks of initiation of therapy, or can occur months or years after treatment, and symptoms include diarrhea, nausea, cramps, urgency, mucus discharge and painful defecation. Experts believe that RP occurs due to damage to the blood vessels that occurs as part of the radiation therapy.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard was launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States, RHEI Pharmaceuticals in China, and Hanmi Pharmaceuticals in Korea. Clinical data on MuGard®, entitled "Multi-Institutional, Randomized, Double Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptom in Patients being treated With Chemoradiation Therapy for Cancers of the Head and Neck," was recently published online at onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products including ProctiGard™. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Scott Nogi
Vice President
Access Pharmaceuticals, Inc.
(212) 786-6203
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
Access Pharmaceuticals Provides Strategic Update On Mucoadhesive Polymer Hydrogel Technology
14:20 01.04.14
PR Newswire
NEW YORK, April 1, 2014
NEW YORK, April 1, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) provided investors with a strategic update on its programs and plans for its proprietary mucoadhesive hydrogel platform technology. Access' patented technology surrounds a unique aqueous pseudoplastic liquid with a defined viscosity range, which is beneficial to the treatment of disorders of mucosal tissue, and includes the ability to act as a delivery system for a variety of active agents, including drugs.
The mucoadhesive hydrogel technology is the basis for its product MuGard® which is indicated for conditions of the oral mucosa, including oral mucositis, and Access Pharmaceuticals is expanding its potential application in other mucosal tissues including the esophagus, the lower intestinal tract and the vagina. The Company is exploring formulations with active agents that may include anesthetics, such as benzocaine, anti-fungal agents, anti-inflammatory drugs and medical foods and supplements. Combinations of Access' technology and active agents could take advantage of expedited regulatory pathways, such as the 505(b)(2) and 510(k) pathways, and offer extended patent protection for generic agents or those soon to lose patent protection.
"Access has recently filed for expanded patent protection of its mucoadhesive polymer hydrogel technology and is engaged with regulatory consultants and bodies on the identification of appropriate pathways for a number of MuGard® follow-on products," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "The recently announced ProctiGard™ program, for radiation proctitis, is the first of a number of product programs that highlights the power of this drug delivery platform."
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States, RHEI/Jian An Pharmaceuticals in China, and Hanmi Pharmaceuticals in Korea. Clinical data on MuGard®, entitled "Multi-Institutional, Randomized, Double Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptom in Patients being treated With Chemoradiation Therapy for Cancers of the Head and Neck," was recently published online at onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products including ProctiGard™. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Christine Berni
Access Pharmaceuticals, Inc.
(212) 786-6208
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
14:20 01.04.14
PR Newswire
NEW YORK, April 1, 2014
NEW YORK, April 1, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) provided investors with a strategic update on its programs and plans for its proprietary mucoadhesive hydrogel platform technology. Access' patented technology surrounds a unique aqueous pseudoplastic liquid with a defined viscosity range, which is beneficial to the treatment of disorders of mucosal tissue, and includes the ability to act as a delivery system for a variety of active agents, including drugs.
The mucoadhesive hydrogel technology is the basis for its product MuGard® which is indicated for conditions of the oral mucosa, including oral mucositis, and Access Pharmaceuticals is expanding its potential application in other mucosal tissues including the esophagus, the lower intestinal tract and the vagina. The Company is exploring formulations with active agents that may include anesthetics, such as benzocaine, anti-fungal agents, anti-inflammatory drugs and medical foods and supplements. Combinations of Access' technology and active agents could take advantage of expedited regulatory pathways, such as the 505(b)(2) and 510(k) pathways, and offer extended patent protection for generic agents or those soon to lose patent protection.
"Access has recently filed for expanded patent protection of its mucoadhesive polymer hydrogel technology and is engaged with regulatory consultants and bodies on the identification of appropriate pathways for a number of MuGard® follow-on products," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "The recently announced ProctiGard™ program, for radiation proctitis, is the first of a number of product programs that highlights the power of this drug delivery platform."
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States, RHEI/Jian An Pharmaceuticals in China, and Hanmi Pharmaceuticals in Korea. Clinical data on MuGard®, entitled "Multi-Institutional, Randomized, Double Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptom in Patients being treated With Chemoradiation Therapy for Cancers of the Head and Neck," was recently published online at onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products including ProctiGard™. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Christine Berni
Access Pharmaceuticals, Inc.
(212) 786-6208
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
On Development Of LexaGard, A Proprietary Formulation Of Amlexanox
14:35 08.04.14
PR Newswire
NEW YORK, April 8, 2014
NEW YORK, April 8, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) provided an update on a new formulation of the anti-inflammatory drug amlexanox, called LexaGard™, for the treatment of inflammatory and ulcerative conditions of the esophagus. Amlexanox is a novel anti-inflammatory and anti-allergic agent that has been approved and used in the US, Japan and other countries, in numerous formulations, for the treatment of a variety of conditions including recurrent aphthous ulceration (RAU), bronchial asthma and allergic rhinitis. Amlexanox is known to inhibit formation and release of histamine, TNF-alpha and leukotriene from mast cells, basophils and neutrophils, and has strong anti-inflammatory effects in mucosal tissue with few adverse effects. By formulating amlexanox in its proprietary mucoadhesive polymer hydrogel delivery system, Access has a patented and protectable formulation of this interesting pharmaceutical active.
"Leveraging upon our success with MuGard®, Access is actively working on a number of follow-on products that focus on applications of our base product in other mucosal tissue, such as the recently discussed ProctiGard™ for the treatment of radiation proctitis, and now LexaGard™ which incorporates an active pharmaceutical agent," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "While Access is exploring the use of LexaGard™ in the esophagus, in conditions such as Barrett's esophagus, amlexanox has been gaining renewed attention recently as academic studies have shown that it may have broad utility in a number of conditions that are caused or exacerbated by chronic, low-level inflammation, such as diabetes, obesity and a variety of neurological conditions. We believe a proprietary formulation of amlexanox, in an easy to use format, could have broad clinical applications and commercial appeal."
LexaGard™ is a proprietary formulation of amlexanox in a mucoadhesive hydrogel formulation designed for treatment of conditions of the upper gastrointestinal tract including Barrett's esophagus and esophagitis. Amlexanox has been shown to be as effective as dexamethasone in treatment of erosive oral lichen planus. Barrett's esophagus is a pre-cancerous condition thought to be caused by chronic acid exposure from reflux esophagitis, and is estimated to be present in 10% to 20% of patients with gastroesophageal reflux disease (GERD).
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard® is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard® was launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States, RHEI Pharmaceuticals in China, and Hanmi Pharmaceuticals in Korea. Clinical data on MuGard®, entitled "Multi-Institutional, Randomized, Double Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptom in Patients being treated With Chemoradiation Therapy for Cancers of the Head and Neck," was recently published online at onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard® and is developing multiple follow-on products including ProctiGard™. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Scott Nogi
Vice President
Access Pharmaceuticals, Inc.
(212) 786-6203
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
14:35 08.04.14
PR Newswire
NEW YORK, April 8, 2014
NEW YORK, April 8, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) provided an update on a new formulation of the anti-inflammatory drug amlexanox, called LexaGard™, for the treatment of inflammatory and ulcerative conditions of the esophagus. Amlexanox is a novel anti-inflammatory and anti-allergic agent that has been approved and used in the US, Japan and other countries, in numerous formulations, for the treatment of a variety of conditions including recurrent aphthous ulceration (RAU), bronchial asthma and allergic rhinitis. Amlexanox is known to inhibit formation and release of histamine, TNF-alpha and leukotriene from mast cells, basophils and neutrophils, and has strong anti-inflammatory effects in mucosal tissue with few adverse effects. By formulating amlexanox in its proprietary mucoadhesive polymer hydrogel delivery system, Access has a patented and protectable formulation of this interesting pharmaceutical active.
"Leveraging upon our success with MuGard®, Access is actively working on a number of follow-on products that focus on applications of our base product in other mucosal tissue, such as the recently discussed ProctiGard™ for the treatment of radiation proctitis, and now LexaGard™ which incorporates an active pharmaceutical agent," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "While Access is exploring the use of LexaGard™ in the esophagus, in conditions such as Barrett's esophagus, amlexanox has been gaining renewed attention recently as academic studies have shown that it may have broad utility in a number of conditions that are caused or exacerbated by chronic, low-level inflammation, such as diabetes, obesity and a variety of neurological conditions. We believe a proprietary formulation of amlexanox, in an easy to use format, could have broad clinical applications and commercial appeal."
LexaGard™ is a proprietary formulation of amlexanox in a mucoadhesive hydrogel formulation designed for treatment of conditions of the upper gastrointestinal tract including Barrett's esophagus and esophagitis. Amlexanox has been shown to be as effective as dexamethasone in treatment of erosive oral lichen planus. Barrett's esophagus is a pre-cancerous condition thought to be caused by chronic acid exposure from reflux esophagitis, and is estimated to be present in 10% to 20% of patients with gastroesophageal reflux disease (GERD).
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard® is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard® was launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States, RHEI Pharmaceuticals in China, and Hanmi Pharmaceuticals in Korea. Clinical data on MuGard®, entitled "Multi-Institutional, Randomized, Double Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptom in Patients being treated With Chemoradiation Therapy for Cancers of the Head and Neck," was recently published online at onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard® and is developing multiple follow-on products including ProctiGard™. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Scott Nogi
Vice President
Access Pharmaceuticals, Inc.
(212) 786-6203
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
Of MuGard Study In Erosive Oral Lichen Planus Presented At International Oral Medicine Meeting
14:35 15.04.14
PR Newswire
NEW YORK, April 15, 2014
NEW YORK, April 15, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biotechnology company, announced today that positive results from a study conducted at Nova Southeastern University were presented recently at the Frontiers in Oral Medicine 2014 conference, hosted by the American Academy of Oral Medicine, in Orlando, Florida. The poster, entitled "Effectiveness of a Polymer-Based Muco-Adhesive (MuGard®) in the Healing of Oral Ulcers in Erosive Lichen Planus: A Pilot Study" reflected results of a randomized, doubled-blinded study (1:1 randomization into MuGard® or bicarbonate rinse arm) of 20 patients with biopsy proven oral lichen planus. Patients in the MuGard® arm had statistically significant improvement in ulcerations and pain, and the changes in pain were closely related to the health of the ulcers. There was no statistically significant change in erythema.
"Oral lichen planus is a significant unmet medical need, that presents similarly to oral mucositis, with inflammation, erosive ulceration and significant pain," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "The results of this study, like others previously announced by Access, add to the growing body of clinical evidence of the significant benefits offered by MuGard®to patients suffering with a variety of conditions of the oral cavity."
Oral lichen planus ("OLP") is a chronic, dermatologic autoimmune disease affecting mucosal tissue and skin including, but not limited to, the oral cavity, pharynx, esophagus, nails and scalp. The prevalence of oral lichen planus in the US is unknown, but it is estimated to affect approximately one to two percent of the general adult population, predominately in adults older than 40 years, although younger adults and children can be affected. Patients with OLP are believed to have a higher risk of oral cancer and should be monitored regularly. Typically treatment includes systemic steroids or immunosuppressants, and there is a significant need for additional treatment regimens.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States, RHEI Pharmaceuticals in China, and Hanmi Pharmaceuticals in Korea. Clinical data on MuGard®, entitled "Multi-Institutional, Randomized, Double Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptom in Patients being treated With Chemoradiation Therapy for Cancers of the Head and Neck," was recently published online at onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products including ProctiGard™. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Christine Berni
Vice President, Corporate Development
Access Pharmaceuticals, Inc.
(212) 786-6203
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
14:35 15.04.14
PR Newswire
NEW YORK, April 15, 2014
NEW YORK, April 15, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biotechnology company, announced today that positive results from a study conducted at Nova Southeastern University were presented recently at the Frontiers in Oral Medicine 2014 conference, hosted by the American Academy of Oral Medicine, in Orlando, Florida. The poster, entitled "Effectiveness of a Polymer-Based Muco-Adhesive (MuGard®) in the Healing of Oral Ulcers in Erosive Lichen Planus: A Pilot Study" reflected results of a randomized, doubled-blinded study (1:1 randomization into MuGard® or bicarbonate rinse arm) of 20 patients with biopsy proven oral lichen planus. Patients in the MuGard® arm had statistically significant improvement in ulcerations and pain, and the changes in pain were closely related to the health of the ulcers. There was no statistically significant change in erythema.
"Oral lichen planus is a significant unmet medical need, that presents similarly to oral mucositis, with inflammation, erosive ulceration and significant pain," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "The results of this study, like others previously announced by Access, add to the growing body of clinical evidence of the significant benefits offered by MuGard®to patients suffering with a variety of conditions of the oral cavity."
Oral lichen planus ("OLP") is a chronic, dermatologic autoimmune disease affecting mucosal tissue and skin including, but not limited to, the oral cavity, pharynx, esophagus, nails and scalp. The prevalence of oral lichen planus in the US is unknown, but it is estimated to affect approximately one to two percent of the general adult population, predominately in adults older than 40 years, although younger adults and children can be affected. Patients with OLP are believed to have a higher risk of oral cancer and should be monitored regularly. Typically treatment includes systemic steroids or immunosuppressants, and there is a significant need for additional treatment regimens.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States, RHEI Pharmaceuticals in China, and Hanmi Pharmaceuticals in Korea. Clinical data on MuGard®, entitled "Multi-Institutional, Randomized, Double Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptom in Patients being treated With Chemoradiation Therapy for Cancers of the Head and Neck," was recently published online at onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products including ProctiGard™. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Christine Berni
Vice President, Corporate Development
Access Pharmaceuticals, Inc.
(212) 786-6203
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
Access Pharmaceuticals Awarded Hong Kong Patent For MuGard
17:00 08.07.14
PR Newswire
DALLAS and NEW YORK, July 8, 2014
DALLAS and NEW YORK, July 8, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, has received notification from the Hong Kong Patent Office that a patent for MuGard™ has been granted. The patent (HK1126134) protects a wide range of liquid formulations for the prevention and treatment of mucosal diseases and disorders.
"Being awarded the Hong Kong patent further expands and further strengthens our global MuGard patent portfolio position," commented Jeffrey Davis, President and CEO of Access. "We are actively seeking additional marketing partners worldwide and bolstering MuGard patent protection in areas like Hong Kong is in line with this licensing strategy."
MuGard provides the oral mucosa with a thin protective hydrogel layer which has been demonstrated in several clinical studies of mucositis to benefit patients in terms of reduced pain and discomfort as well as a reduction in objective mucositis scores.
Access recently announced that one of the oldest peer-reviewed journals in oncology, the American Cancer Society's journal publication, Cancer, featured MuGard as the cover article of its May 2014 edition. The publication, entitled "Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and Neck," discusses data on Access' post-marketing clinical trial that evaluated the efficacy of MuGard in controlling symptoms caused by oral mucositis in 120 patients receiving chemoradiation therapy for the treatment of cancers of the head and neck. In the trial, MuGard was shown to be superior to the sham control saline-bicarbonate rinse in mitigating oral mucositis symptoms and delaying oral mucositis progression. The article can be accessed by clicking on the following link: onlinelibrary.wiley.com/enhanced/doi/10.1002/cncr.28553/
Oral Mucositis: Oral mucositis ("OM") is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. There are an estimated 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States. MuGard is also licensed in China, RHEI/Jian An, and in Korea with Hamni Pharmaceuticals.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Christine Berni
VP Corporate Development
Access Pharmaceuticals, Inc.
(212) 786-6208
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
17:00 08.07.14
PR Newswire
DALLAS and NEW YORK, July 8, 2014
DALLAS and NEW YORK, July 8, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, has received notification from the Hong Kong Patent Office that a patent for MuGard™ has been granted. The patent (HK1126134) protects a wide range of liquid formulations for the prevention and treatment of mucosal diseases and disorders.
"Being awarded the Hong Kong patent further expands and further strengthens our global MuGard patent portfolio position," commented Jeffrey Davis, President and CEO of Access. "We are actively seeking additional marketing partners worldwide and bolstering MuGard patent protection in areas like Hong Kong is in line with this licensing strategy."
MuGard provides the oral mucosa with a thin protective hydrogel layer which has been demonstrated in several clinical studies of mucositis to benefit patients in terms of reduced pain and discomfort as well as a reduction in objective mucositis scores.
Access recently announced that one of the oldest peer-reviewed journals in oncology, the American Cancer Society's journal publication, Cancer, featured MuGard as the cover article of its May 2014 edition. The publication, entitled "Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and Neck," discusses data on Access' post-marketing clinical trial that evaluated the efficacy of MuGard in controlling symptoms caused by oral mucositis in 120 patients receiving chemoradiation therapy for the treatment of cancers of the head and neck. In the trial, MuGard was shown to be superior to the sham control saline-bicarbonate rinse in mitigating oral mucositis symptoms and delaying oral mucositis progression. The article can be accessed by clicking on the following link: onlinelibrary.wiley.com/enhanced/doi/10.1002/cncr.28553/
Oral Mucositis: Oral mucositis ("OM") is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. There are an estimated 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States. MuGard is also licensed in China, RHEI/Jian An, and in Korea with Hamni Pharmaceuticals.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Christine Berni
VP Corporate Development
Access Pharmaceuticals, Inc.
(212) 786-6208
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
Access Pharmaceuticals Receives 510(K) FDA Marketing Clearance For ProctiGard™
14:35 22.07.14
PR Newswire
DALLAS and NEW YORK, July 22, 2014
DALLAS and NEW YORK, July 22, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a developer of new products for oncology supportive care, announced today that it has received 510(K) marketing clearance from the U.S. Food and Drug Administration (FDA) for ProctiGard™, its novel treatment for symptomatic management of rectal mucositis. The Company indicated its development of ProctiGard™ is a direct response to dialogue with the oncology community that is looking for better, more effective treatment options for rectal mucositis and radiation proctitis, a debilitating oncology side effect. Access believes that ProctiGard is a first-in-class treatment option that addresses a significant unmet medical need. Access currently holds global commercialization rights for ProctiGard.
"This second FDA marketing clearance is an important milestone for Access following the decision to focus on the development and commercialization of a portfolio of follow-on proprietary products," said Jeffrey Davis, CEO of Access Pharmaceuticals. He continued, "Rectal mucositis and radiation proctitis, presenting as inflammation and damage to the lower part of colon, is a common adverse event of the radiotherapy of tumors in the abdominal and pelvic region with no well-established effective standard of care. With the introduction of ProctiGard™, we look forward to providing cancer patients with an important treatment that manages this debilitating disease."
Radiation proctitis (RP) is a condition analogous to oral mucositis in the oral cavity, concerning the inflammation and damage to lower parts of the colon following pelvic radiation to the region. Rectal mucositis, a broader condition, can also be caused by factors other than radiation, including bacterial, viral or fungal infections, parasites, contact allergies or food allergies, and surgery. It is estimated that there are in excess of 250,000 new cases of prostate, cervical, rectal, testicular, bladder and endometrial cancer diagnosed each year. Approximately 50% of these patients require radiation therapy, and roughly 75% of patients undergoing pelvic irradiation experience radiation proctitis. Access is actively evaluating commercialization options for ProctiGard™, including the seeking of global marketing partners.
About Rectal Mucositis / Radiation Proctitis
Rectal mucositis, and specifically radiation proctitis, is the inflammation and damage to the lower portion of the colon, primarily the sigmoid colon and rectum, after exposure to x-rays or ionizing radiation as part of radiation therapy. RP is most common after treatments for cancer, such as cervical, colon, and prostate cancer. RP can be acute, occurring within weeks of initiation of therapy, or can occur months or years after treatment, and symptoms include diarrhea, nausea, cramps, urgency, mucus discharge and painful defecation. Experts believe that RP occurs due to damage to the blood vessels that occurs as part of the radiation therapy.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Christine Berni
VP Corporate Development
Access Pharmaceuticals, Inc.
(212) 786-6208
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
14:35 22.07.14
PR Newswire
DALLAS and NEW YORK, July 22, 2014
DALLAS and NEW YORK, July 22, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a developer of new products for oncology supportive care, announced today that it has received 510(K) marketing clearance from the U.S. Food and Drug Administration (FDA) for ProctiGard™, its novel treatment for symptomatic management of rectal mucositis. The Company indicated its development of ProctiGard™ is a direct response to dialogue with the oncology community that is looking for better, more effective treatment options for rectal mucositis and radiation proctitis, a debilitating oncology side effect. Access believes that ProctiGard is a first-in-class treatment option that addresses a significant unmet medical need. Access currently holds global commercialization rights for ProctiGard.
"This second FDA marketing clearance is an important milestone for Access following the decision to focus on the development and commercialization of a portfolio of follow-on proprietary products," said Jeffrey Davis, CEO of Access Pharmaceuticals. He continued, "Rectal mucositis and radiation proctitis, presenting as inflammation and damage to the lower part of colon, is a common adverse event of the radiotherapy of tumors in the abdominal and pelvic region with no well-established effective standard of care. With the introduction of ProctiGard™, we look forward to providing cancer patients with an important treatment that manages this debilitating disease."
Radiation proctitis (RP) is a condition analogous to oral mucositis in the oral cavity, concerning the inflammation and damage to lower parts of the colon following pelvic radiation to the region. Rectal mucositis, a broader condition, can also be caused by factors other than radiation, including bacterial, viral or fungal infections, parasites, contact allergies or food allergies, and surgery. It is estimated that there are in excess of 250,000 new cases of prostate, cervical, rectal, testicular, bladder and endometrial cancer diagnosed each year. Approximately 50% of these patients require radiation therapy, and roughly 75% of patients undergoing pelvic irradiation experience radiation proctitis. Access is actively evaluating commercialization options for ProctiGard™, including the seeking of global marketing partners.
About Rectal Mucositis / Radiation Proctitis
Rectal mucositis, and specifically radiation proctitis, is the inflammation and damage to the lower portion of the colon, primarily the sigmoid colon and rectum, after exposure to x-rays or ionizing radiation as part of radiation therapy. RP is most common after treatments for cancer, such as cervical, colon, and prostate cancer. RP can be acute, occurring within weeks of initiation of therapy, or can occur months or years after treatment, and symptoms include diarrhea, nausea, cramps, urgency, mucus discharge and painful defecation. Experts believe that RP occurs due to damage to the blood vessels that occurs as part of the radiation therapy.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Christine Berni
VP Corporate Development
Access Pharmaceuticals, Inc.
(212) 786-6208
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
::::::::::::::::::: 0,30 $ +11,11% +0,03 $
In Euro: 0,2227 € | Nasdaq OTC Other, 22.07.14::::::::: haaaaach watt iss uns SCHÖN
In Euro: 0,2227 € | Nasdaq OTC Other, 22.07.14::::::::: haaaaach watt iss uns SCHÖN
Access Pharmaceuticals Featured On OncLive.com
14:35 30.07.14
PR Newswire
DALLAS and NEW YORK, July 30, 2014
DALLAS and NEW YORK, July 30, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a developer of new products for oncology supportive care, announced that its novel product for oral mucositis, MuGard®, has been featured in an article on OncLive.com titled, "Study Finds Mouth Rinse Alleviates Oral Mucositis Symptoms in Head and Neck Cancers." Dr. Steve Sonis, a leading expert in oral mucositis, provides insight on the growing demand seen in the oncology community for evidence-based strategies for the debilitating anticancer regimen side effect.
The article can be read by clicking on the following link: www.onclive.com/publications/Oncology-live/...sh.f3xlnzkt.dpuf
Oral Mucositis: Oral mucositis ("OM") is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. There are an estimated 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States. MuGard is also licensed in China with RHEI/Jian An, and in Korea with Hamni Pharmaceuticals.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Christine Berni
VP Corporate Development
Access Pharmaceuticals, Inc.
(212) 786-6208
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
14:35 30.07.14
PR Newswire
DALLAS and NEW YORK, July 30, 2014
DALLAS and NEW YORK, July 30, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a developer of new products for oncology supportive care, announced that its novel product for oral mucositis, MuGard®, has been featured in an article on OncLive.com titled, "Study Finds Mouth Rinse Alleviates Oral Mucositis Symptoms in Head and Neck Cancers." Dr. Steve Sonis, a leading expert in oral mucositis, provides insight on the growing demand seen in the oncology community for evidence-based strategies for the debilitating anticancer regimen side effect.
The article can be read by clicking on the following link: www.onclive.com/publications/Oncology-live/...sh.f3xlnzkt.dpuf
Oral Mucositis: Oral mucositis ("OM") is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. There are an estimated 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States. MuGard is also licensed in China with RHEI/Jian An, and in Korea with Hamni Pharmaceuticals.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Christine Berni
VP Corporate Development
Access Pharmaceuticals, Inc.
(212) 786-6208
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
Datum Erster Hoch Tief Schluss Stücke Volumen
30.07.14 0,2915 0,2915§0,25 0,25 $ 265.597 69 T
GrB
30.07.14 0,2915 0,2915§0,25 0,25 $ 265.597 69 T
GrB
Access Pharmaceuticals Announces European License Agreement With Norgine
14:05 07.08.14
PR Newswire
DALLAS and NEW YORK, Aug. 7, 2014
DALLAS and NEW YORK, Aug. 7, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, today announced that it had entered into an exclusive license agreement with Norgine B.V., a leading independent European specialty pharmaceutical company, for the commercialization of MuGard in Europe. Under the terms of the license agreement, Access will receive up to $10 million in milestone payments and an escalating double digit royalty on the net sales of the oral mucositis product, MuGard, in the licensed territories. Norgine will develop, manufacture, and commercialize MuGard in the European Union, Switzerland, Norway, Iceland and Lichtenstein. Norgine anticipates launching MuGard in 2015.
Commenting on the news, Jeffrey Davis, CEO of Access Pharmaceuticals, Inc stated, "Access is excited to announce this partnership with Norgine, a leading European specialty company, as it further validates our global MuGard commercial strategy." He added, "With product offerings in complementary therapeutic areas and an established presence in the cancer supportive care space, Norgine is an ideal partner for us and we believe this partnership will drive commercial adoption in Europe and facilitate access of a proven treatment option to help protect patients from oral mucositis, a debilitating side effect."
"This new partnership with Access Pharmaceuticals Inc. represents an excellent opportunity to ensure that cancer patients affected by oral mucositis can access MuGard, to help manage this condition for which there are limited effective treatment options," said Peter Stein, CEO of Norgine. He continued, "This collaboration is further evidence of Norgine's commitment to acquire specialty pharmaceutical products to strengthen its portfolio."
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States. MuGard is also licensed in China, RHEI/Jian An, and in Korea with Hamni Pharmaceuticals.
About Norgine
Norgine is a leading independent European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. In 2013, Norgine's total revenue was €274 million and the company employs over 1,000 people.
Norgine's focus is the development and marketing of pharmaceutical products that address significant unmet clinical needs in therapeutic areas such as gastroenterology, hepatology , critical and supportive care. Norgine owns a manufacturing and development site in Hengoed, UK and a manufacturing site in Dreux, France. In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US.
For more information, please visit www.norgine.com
About Access
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access' products include MuGard™ (www.MuGard.com), which has received FDA-marketing clearance for the management of patients with mucositis, and ProLindac™, a second generation DACH platinum drug. The Company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Christine Berni
Director of Investor Relations
Access Pharmaceuticals, Inc.
(212) 786-6208
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
14:05 07.08.14
PR Newswire
DALLAS and NEW YORK, Aug. 7, 2014
DALLAS and NEW YORK, Aug. 7, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, today announced that it had entered into an exclusive license agreement with Norgine B.V., a leading independent European specialty pharmaceutical company, for the commercialization of MuGard in Europe. Under the terms of the license agreement, Access will receive up to $10 million in milestone payments and an escalating double digit royalty on the net sales of the oral mucositis product, MuGard, in the licensed territories. Norgine will develop, manufacture, and commercialize MuGard in the European Union, Switzerland, Norway, Iceland and Lichtenstein. Norgine anticipates launching MuGard in 2015.
Commenting on the news, Jeffrey Davis, CEO of Access Pharmaceuticals, Inc stated, "Access is excited to announce this partnership with Norgine, a leading European specialty company, as it further validates our global MuGard commercial strategy." He added, "With product offerings in complementary therapeutic areas and an established presence in the cancer supportive care space, Norgine is an ideal partner for us and we believe this partnership will drive commercial adoption in Europe and facilitate access of a proven treatment option to help protect patients from oral mucositis, a debilitating side effect."
"This new partnership with Access Pharmaceuticals Inc. represents an excellent opportunity to ensure that cancer patients affected by oral mucositis can access MuGard, to help manage this condition for which there are limited effective treatment options," said Peter Stein, CEO of Norgine. He continued, "This collaboration is further evidence of Norgine's commitment to acquire specialty pharmaceutical products to strengthen its portfolio."
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States. MuGard is also licensed in China, RHEI/Jian An, and in Korea with Hamni Pharmaceuticals.
About Norgine
Norgine is a leading independent European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. In 2013, Norgine's total revenue was €274 million and the company employs over 1,000 people.
Norgine's focus is the development and marketing of pharmaceutical products that address significant unmet clinical needs in therapeutic areas such as gastroenterology, hepatology , critical and supportive care. Norgine owns a manufacturing and development site in Hengoed, UK and a manufacturing site in Dreux, France. In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US.
For more information, please visit www.norgine.com
About Access
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access' products include MuGard™ (www.MuGard.com), which has received FDA-marketing clearance for the management of patients with mucositis, and ProLindac™, a second generation DACH platinum drug. The Company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
Company and Media Contact:
Christine Berni
Director of Investor Relations
Access Pharmaceuticals, Inc.
(212) 786-6208
SOURCE Access Pharmaceuticals, Inc.
Quelle: PR Newswire
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