CytoCore Announces the Licensing of a New Bio-Marker That Identifies Uterine Pre-Cancerous and Cancer Cells
As part of the recently signed technology transfer agreement, CytoCore, Inc. (OTCBB: MCDG), a bio-technology development company committed to bringing new cancer solutions to market, today announced that it has licensed a new cancer bio-marker from Dr. George Gorodeski, the inventor, and University Hospitals Cleveland.
The new biomarker, labeled CGI5 is unique among the few apoptosis markers that were found in preliminary experiments to distinguish pre-cancerous and cancer cells from the corresponding normal cells. Cells that transform into cancer cells usually display two distinctive characteristics: rapid, uninhibited proliferation, and a slowing of programmed cell death (apoptosis). Current bio-marker technology has typically focused on proteins associated with cell proliferation. CytoCore's CGI5 bio-marker tracks the changes in the dying or apoptotic process. The initial lab results have produced excellent sensitivity and specificity (measures of bio-marker accuracy) in testing for both Cervical and Endometrial cancers.
Dr. David Weissberg, CytoCore's CEO stated: "We are very excited by the prospects this bio-marker brings to CytoCore. Early indications suggest that when combined with the other more standard proliferation bio-markers such as EGFR and IGFR, through triangulation, produces an assay with increased accuracy for identifying both cervical and endometrial cancers. The tests also suggest that the marker may have more general applications in other types of epithelial cancers, such as skin cancer. This marker when combined with our existing CVX assay has produced some very accurate initial test results in Dr. Gorodeski's lab. We will be working with Dr. Gorodeski to put together the plans for initial trials on this marker."
The CGI5 marker offers CytoCore commercial potential in several areas.
One, when combined with the Company's existing CVX assay, the new combined Assay, called the GCI Assay, significantly increased the accuracy of the initial tests for cervical cancer screening. Trials will begin on this new combination Assay as soon as it is optimized for operation with the AIPS automated microscopy platform.
Two, if the lab test results are verified in the trials, the level of accuracy of GCI Assay could allow it to become a diagnostic test. The requirements and accuracy required by a diagnostic are higher than for a screening test. However if accuracy is replicated in trials for this new Assay as a diagnostic, it will open up significant new markets for this Assay when utilized with the AIPS platform in analyzing tissue samples.
Dr. George Gorodeski, a Gynecologist at University Hospitals of Cleveland and Professor of Reproductive Biology, Oncology and Physiology and Biophysics at CASE (Case Western Reserve) University stated: "This is an unusual marker, and when combined with more well known markers, has produced some very interesting test results. It is especially gratifying to see these test results with different types of uterine epithelial tissues, thereby potentially providing screening and diagnostic modalities for two common gynecological cancers - cervical and endometrial. The CVX-GCI Assay with the AIPS platform could improve screening for cervical dysplasia and cancer, while the GCI assay could address endometrial cancer."
"Endometrial cancer typically occurs in postmenopausal women and its principal symptom is uterine bleeding usually occurring after the cessation of normal menstrual periods. The occurrence of abnormal uterine bleeding in pre- and peri-menopausal women is relatively common occurring in about 15% of women. Although it is rarely associated with endometrial cancer, it is often a source of significant concern both for the patient and her physician. If our results are confirmed in a larger controlled study I believe that the assay could be developed into a simple, accurate bedside point-of-care screening method for endometrial cancer. This test would provide a rapid-answer reassurance to women who test negative, and would advise prompt additional intervention in cases of a positive suspected result. Such a test is currently lacking and would be an important adjunct for the physician practicing in this area."
Dr. Gorodeski added that he, in collaboration with other physicians at the Department of Obstetrics and Gynecology at University Hospitals of Cleveland plan to soon develop a clinical study protocol and obtain the Institution's approval to begin a clinical trial to test the accuracy of the novel CGI5 marker. "We are all eager to see the results of the expanded trial and the performance of this new marker and Assay."
This new marker and Assay substantially expands CytoCore's InPath System capabilities. Assuming the trials bear out the lab results, this new Assay will be able to identify uterine cancer risks to the cervix and the endometrium expanding the InPath System cancer screening coverage for the entire arc from the onset of sexual activity throughout a woman's life.
About University Hospitals of Cleveland: Founded in 1866, University Hospitals of Cleveland is a 947-bed tertiary medical center specializing in adult/pediatric medical and surgical specialties. UHC is also the primary affiliate of Case Western Reserve University. Together, they form the largest center for biomedical research in the State of Ohio. As the research arm of University Hospitals of Cleveland, the Center for Clinical Research focuses on translational research, taking fundamental advances in biomedical research and applying them to improvements in healthcare. This is achieved through a balanced approach involving federal-funded research, sponsored research agreements with the pharmaceutical, biotechnology and medical device industries, and a century-long partnership with Case Western Reserve University. The Center for Clinical Research is designed to aggressively translate fundamental advances in scientific knowledge into advances in the clinical medicine by establishing new alliances with the pharmaceutical, biotechnology and medical device industries. More information is available at: www.uhhs.com/
About CytoCore, Inc.
CytoCore develops cost-effective cancer screening systems, which can be utilized in a laboratory or at the point-of-care, to assist in the early detection of cervical, gastrointestinal, and other cancers. The InPath(TM) System is being developed to provide medical practitioners with a highly accurate, low-cost, cervical cancer screening system that can be integrated into existing medical models or at the point-of-care.
More information is available at: www.Molecular-Dx.com
Certain statements in this release are forward-looking. These statements are based on CytoCore's current expectations and involve many risks and uncertainties, such as the company's inability to obtain sufficient financing, the possibility that clinical trials will not substantiate CytoCore's expectations with respect to the InPath(TM) System, and other factors set forth in reports and documents filed by CytoCore with the Securities and Exchange Commission. Actual results may differ materially from CytoCore's current expectation depending upon a number of factors affecting the Company's business. These factors include, among others, risks and uncertainties detailed in the Company's periodic public filings with the Securities and Exchange Commission, including but not limited to the Company's Annual Report on Form 10-K for the year ended December 31, 2004 and its Quarterly Reports on Form 10-QSB for the quarters ended June 30, 2005 and September 30, 2005. Except as expressly required by law, CytoCore undertakes no obligation to publicly update or revise any forward-looking statements contained herein.
For CytoCore, Inc.
Gene Martineau, 212-348-1852
ebm@interport.net
Source: Business Wire (February 21, 2006 - 11:41 AM EST)
As part of the recently signed technology transfer agreement, CytoCore, Inc. (OTCBB: MCDG), a bio-technology development company committed to bringing new cancer solutions to market, today announced that it has licensed a new cancer bio-marker from Dr. George Gorodeski, the inventor, and University Hospitals Cleveland.
The new biomarker, labeled CGI5 is unique among the few apoptosis markers that were found in preliminary experiments to distinguish pre-cancerous and cancer cells from the corresponding normal cells. Cells that transform into cancer cells usually display two distinctive characteristics: rapid, uninhibited proliferation, and a slowing of programmed cell death (apoptosis). Current bio-marker technology has typically focused on proteins associated with cell proliferation. CytoCore's CGI5 bio-marker tracks the changes in the dying or apoptotic process. The initial lab results have produced excellent sensitivity and specificity (measures of bio-marker accuracy) in testing for both Cervical and Endometrial cancers.
Dr. David Weissberg, CytoCore's CEO stated: "We are very excited by the prospects this bio-marker brings to CytoCore. Early indications suggest that when combined with the other more standard proliferation bio-markers such as EGFR and IGFR, through triangulation, produces an assay with increased accuracy for identifying both cervical and endometrial cancers. The tests also suggest that the marker may have more general applications in other types of epithelial cancers, such as skin cancer. This marker when combined with our existing CVX assay has produced some very accurate initial test results in Dr. Gorodeski's lab. We will be working with Dr. Gorodeski to put together the plans for initial trials on this marker."
The CGI5 marker offers CytoCore commercial potential in several areas.
One, when combined with the Company's existing CVX assay, the new combined Assay, called the GCI Assay, significantly increased the accuracy of the initial tests for cervical cancer screening. Trials will begin on this new combination Assay as soon as it is optimized for operation with the AIPS automated microscopy platform.
Two, if the lab test results are verified in the trials, the level of accuracy of GCI Assay could allow it to become a diagnostic test. The requirements and accuracy required by a diagnostic are higher than for a screening test. However if accuracy is replicated in trials for this new Assay as a diagnostic, it will open up significant new markets for this Assay when utilized with the AIPS platform in analyzing tissue samples.
Dr. George Gorodeski, a Gynecologist at University Hospitals of Cleveland and Professor of Reproductive Biology, Oncology and Physiology and Biophysics at CASE (Case Western Reserve) University stated: "This is an unusual marker, and when combined with more well known markers, has produced some very interesting test results. It is especially gratifying to see these test results with different types of uterine epithelial tissues, thereby potentially providing screening and diagnostic modalities for two common gynecological cancers - cervical and endometrial. The CVX-GCI Assay with the AIPS platform could improve screening for cervical dysplasia and cancer, while the GCI assay could address endometrial cancer."
"Endometrial cancer typically occurs in postmenopausal women and its principal symptom is uterine bleeding usually occurring after the cessation of normal menstrual periods. The occurrence of abnormal uterine bleeding in pre- and peri-menopausal women is relatively common occurring in about 15% of women. Although it is rarely associated with endometrial cancer, it is often a source of significant concern both for the patient and her physician. If our results are confirmed in a larger controlled study I believe that the assay could be developed into a simple, accurate bedside point-of-care screening method for endometrial cancer. This test would provide a rapid-answer reassurance to women who test negative, and would advise prompt additional intervention in cases of a positive suspected result. Such a test is currently lacking and would be an important adjunct for the physician practicing in this area."
Dr. Gorodeski added that he, in collaboration with other physicians at the Department of Obstetrics and Gynecology at University Hospitals of Cleveland plan to soon develop a clinical study protocol and obtain the Institution's approval to begin a clinical trial to test the accuracy of the novel CGI5 marker. "We are all eager to see the results of the expanded trial and the performance of this new marker and Assay."
This new marker and Assay substantially expands CytoCore's InPath System capabilities. Assuming the trials bear out the lab results, this new Assay will be able to identify uterine cancer risks to the cervix and the endometrium expanding the InPath System cancer screening coverage for the entire arc from the onset of sexual activity throughout a woman's life.
About University Hospitals of Cleveland: Founded in 1866, University Hospitals of Cleveland is a 947-bed tertiary medical center specializing in adult/pediatric medical and surgical specialties. UHC is also the primary affiliate of Case Western Reserve University. Together, they form the largest center for biomedical research in the State of Ohio. As the research arm of University Hospitals of Cleveland, the Center for Clinical Research focuses on translational research, taking fundamental advances in biomedical research and applying them to improvements in healthcare. This is achieved through a balanced approach involving federal-funded research, sponsored research agreements with the pharmaceutical, biotechnology and medical device industries, and a century-long partnership with Case Western Reserve University. The Center for Clinical Research is designed to aggressively translate fundamental advances in scientific knowledge into advances in the clinical medicine by establishing new alliances with the pharmaceutical, biotechnology and medical device industries. More information is available at: www.uhhs.com/
About CytoCore, Inc.
CytoCore develops cost-effective cancer screening systems, which can be utilized in a laboratory or at the point-of-care, to assist in the early detection of cervical, gastrointestinal, and other cancers. The InPath(TM) System is being developed to provide medical practitioners with a highly accurate, low-cost, cervical cancer screening system that can be integrated into existing medical models or at the point-of-care.
More information is available at: www.Molecular-Dx.com
Certain statements in this release are forward-looking. These statements are based on CytoCore's current expectations and involve many risks and uncertainties, such as the company's inability to obtain sufficient financing, the possibility that clinical trials will not substantiate CytoCore's expectations with respect to the InPath(TM) System, and other factors set forth in reports and documents filed by CytoCore with the Securities and Exchange Commission. Actual results may differ materially from CytoCore's current expectation depending upon a number of factors affecting the Company's business. These factors include, among others, risks and uncertainties detailed in the Company's periodic public filings with the Securities and Exchange Commission, including but not limited to the Company's Annual Report on Form 10-K for the year ended December 31, 2004 and its Quarterly Reports on Form 10-QSB for the quarters ended June 30, 2005 and September 30, 2005. Except as expressly required by law, CytoCore undertakes no obligation to publicly update or revise any forward-looking statements contained herein.
For CytoCore, Inc.
Gene Martineau, 212-348-1852
ebm@interport.net
Source: Business Wire (February 21, 2006 - 11:41 AM EST)
