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WKN: 900425
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Gruss E.
MacroChem Reports FDA Has Placed Its INDs on Clinical Hold
Updated: Friday, October 11, 2002 01:17 PM ET Printer-friendly version
LEXINGTON, Mass., Oct. 11 /PRNewswire-FirstCall/-- MacroChem Corp. (Nasdaq: MCHM, news) announced today that the Food and Drug Administration (FDA) has advised the Company that further clinical trials of MacroChem's drugs containing its absorption enhancer SEPA(R) have been placed on clinical hold until issues regarding a transgenic mouse carcinogenicity study have been resolved. During the clinical hold, the Company will be unable to conduct human clinical trials on its SEPA-based investigational drug products.
According to the FDA, the Executive Committee of its Carcinogenicity Advisory Committee has determined that SEPA is responsible for carcinogenic findings in a six-month transgenic Tg.AC mouse assay. That study, which was conducted by MacroChem in 1999 and reported to the FDA in February 2000, yielded no adverse effects at SEPA doses up to 50 mg/kg/day. At the two highest doses used in the study, skin injury and inflammation preceded the development of papillomas in the treated animals. In contrast, similar skin injury and inflammation was not observed at the lower doses used in the study. The Company believes the papillomas noted at the high doses are a response to skin injury and inflammation in the transgenic mice and not a direct effect of SEPA.
In addition to the transgenic mouse study, MacroChem has completed and submitted to the FDA results from a range of genetic and dermal toxicity studies of SEPA in animals, as well as a two-year rat carcinogenicity study. Results from these studies showed that SEPA was not genotoxic and not carcinogenic.
"We are committed to working with FDA to resolve these issues so that we may continue our clinical development efforts as rapidly as possible," said Robert J. Palmisano, President and Chief Executive Officer of MacroChem.
MacroChem develops topical pharmaceuticals based on its platform absorption-enhancement technology, SEPA(R). Its three lead developmental products are Topiglan(R), a treatment for erectile dysfunction; EcoNail(TM), a SEPA-enhanced nail lacquer to treat nail fungus; and Opterone(TM), a SEPA- enhanced testosterone for hypogonadism.
With the exception of historical information contained in this document, the matters described herein are forward-looking statements and are subject to various risk factors that could cause actual results to differ materially from those expressed in the forward-looking statements. The relevant risk factors are set forth in MacroChem's annual report on Form 10-K as filed with the SEC and include, without limitation, risks regarding product development, clinical trials, dependence on third parties for development and licensing arrangements, and risks involving regulatory approval of products, and patents and licenses.
Visit our web site at: www.macrochem.com
Make Your Opinion Count - Click Here
tbutton.prnewswire.com/prn/11690X61448939
SOURCE MacroChem Corp.
CONTACT: Bernard R. Patriacca of MacroChem Corp.,
WKN: 900425
Gruss E.
MacroChem Reports FDA Has Placed Its INDs on Clinical Hold
Updated: Friday, October 11, 2002 01:17 PM ET Printer-friendly version
LEXINGTON, Mass., Oct. 11 /PRNewswire-FirstCall/-- MacroChem Corp. (Nasdaq: MCHM, news) announced today that the Food and Drug Administration (FDA) has advised the Company that further clinical trials of MacroChem's drugs containing its absorption enhancer SEPA(R) have been placed on clinical hold until issues regarding a transgenic mouse carcinogenicity study have been resolved. During the clinical hold, the Company will be unable to conduct human clinical trials on its SEPA-based investigational drug products.
According to the FDA, the Executive Committee of its Carcinogenicity Advisory Committee has determined that SEPA is responsible for carcinogenic findings in a six-month transgenic Tg.AC mouse assay. That study, which was conducted by MacroChem in 1999 and reported to the FDA in February 2000, yielded no adverse effects at SEPA doses up to 50 mg/kg/day. At the two highest doses used in the study, skin injury and inflammation preceded the development of papillomas in the treated animals. In contrast, similar skin injury and inflammation was not observed at the lower doses used in the study. The Company believes the papillomas noted at the high doses are a response to skin injury and inflammation in the transgenic mice and not a direct effect of SEPA.
In addition to the transgenic mouse study, MacroChem has completed and submitted to the FDA results from a range of genetic and dermal toxicity studies of SEPA in animals, as well as a two-year rat carcinogenicity study. Results from these studies showed that SEPA was not genotoxic and not carcinogenic.
"We are committed to working with FDA to resolve these issues so that we may continue our clinical development efforts as rapidly as possible," said Robert J. Palmisano, President and Chief Executive Officer of MacroChem.
MacroChem develops topical pharmaceuticals based on its platform absorption-enhancement technology, SEPA(R). Its three lead developmental products are Topiglan(R), a treatment for erectile dysfunction; EcoNail(TM), a SEPA-enhanced nail lacquer to treat nail fungus; and Opterone(TM), a SEPA- enhanced testosterone for hypogonadism.
With the exception of historical information contained in this document, the matters described herein are forward-looking statements and are subject to various risk factors that could cause actual results to differ materially from those expressed in the forward-looking statements. The relevant risk factors are set forth in MacroChem's annual report on Form 10-K as filed with the SEC and include, without limitation, risks regarding product development, clinical trials, dependence on third parties for development and licensing arrangements, and risks involving regulatory approval of products, and patents and licenses.
Visit our web site at: www.macrochem.com
Make Your Opinion Count - Click Here
tbutton.prnewswire.com/prn/11690X61448939
SOURCE MacroChem Corp.
CONTACT: Bernard R. Patriacca of MacroChem Corp.,
Von 0,30 locker auf 1,60.
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CardioTech to Acquire Gish Biomedical
Updated: Monday, October 28, 2002 09:36 AM ET Printer-friendly version
WOBURN, Mass. -(Dow Jones)- CardioTech International Inc. (CTE, news) agreed to acquire Gish Biomedical Inc. (GISH, news) for about 4.82 million newly issued shares, with each Gish share exchangeable for 1.3422 CardioTech shares.
In a press release Monday, CardioTech said it expects to obtain a leadership presence in the open-heart surgery field and expands its line of Food and Drug Administration-approved products through the deal.
(This story was originally published by Dow Jones Newswires)
Copyright 2002 Dow Jones & Company, Inc.
All Rights Reserved
CardioTech to Acquire Gish Biomedical
Updated: Monday, October 28, 2002 09:36 AM ET Printer-friendly version
WOBURN, Mass. -(Dow Jones)- CardioTech International Inc. (CTE, news) agreed to acquire Gish Biomedical Inc. (GISH, news) for about 4.82 million newly issued shares, with each Gish share exchangeable for 1.3422 CardioTech shares.
In a press release Monday, CardioTech said it expects to obtain a leadership presence in the open-heart surgery field and expands its line of Food and Drug Administration-approved products through the deal.
(This story was originally published by Dow Jones Newswires)
Copyright 2002 Dow Jones & Company, Inc.
All Rights Reserved
Ích lass mich überraschen, gehe jetzt in die Kneipe. Schönen Abend noch.
Gruss E.
Gruss E.
Gruss E.
chart.bigcharts.com/bc3/quickchart/...39&mocktick=1&rand=9416"
MacroChem Receives Clearance to Resume Clincial Trials of Topical Ed Treatment & Other Enhanced-Absorption Pharmaceuticals
THURSDAY, APRIL 10, 2003 11:06 AM
- PR Newswire
LEXINGTON, Mass., Apr 10, 2003 /PRNewswire-FirstCall via COMTEX/ -- MacroChem Corporation (MCHM) announced today that the U.S. Food & Drug Administration has lifted its October 2002 clinical hold on human trials of topical drugs utilizing the company's patented drug-absorption enhancer, SEPA(R). The clinical hold release does not impose any SEPA dosage or regimen constraints on subsequent trials, which MacroChem plans to restart as soon as possible.
The FDA had imposed a hold on human testing of drugs containing SEPA, pending review of questions surrounding a 26- week transgenic-mouse (Tg.AC) carcinogenicity study of SEPA performed by MacroChem in 1999. In releasing that hold, the FDA has requested additional information on that 1999 study, and MacroChem has agreed to provide it.
"Soon after the FDA issued its hold, MacroChem convened a panel of seven independent experts in Tg.AC testing, carcinogenicity and toxicology," explained Robert J. DeLuccia, interim president and chief executive officer of MacroChem.*
"MacroChem's independent experts reviewed documentation not only on our Tg.AC study, but in addition, our 2-year rat study and our portfolio of other laboratory studies," Mr. DeLuccia said.
At the panel's recommendation, MacroChem performed additional lab studies, including a limited irritation study in Tg.AC mice, and microscopic evaluation of certain mouse skin specimens from the first study. The experts also drew on their knowledge of the literature on transgenic animal testing, and guided MacroChem to publications on Tg.AC studies that support MacroChem's position concerning interpretation of the 1999 Tg.AC study.
"The work of our independent experts and our staff over the past few months was presented to the complete Carcinogenicity Assessment Committee (CAC) of the FDA on March 17," Mr. DeLuccia said.
"Following our presentation, the FDA released the hold on human testing of SEPA-containing drugs, without dosage or regimen restraint. The FDA has asked us to provide it with additional analysis from our 1999 Tg.AC study, in order to determine if an additional animal study might be necessary. MacroChem will continue to work with the FDA to address their questions."
"Obviously, we have lost some valuable time since the imposition of the clinical hold," Mr. DeLuccia observed, "but we're back on track now."
"Continuing discussions with physicians and licensing prospects indicates continued interest in a truly topical ED treatment like our Topiglan. We are not aware of any topical alternatives closer to commercialization than ours, to compete in this multi-billion-dollar potential market."
MacroChem develops drugs utilizing SEPA to permit delivery through skin and nail of drugs ordinarily blocked by the barrier function of those tissues. Delivery through skin can minimize the side effects of some medications, and can enable better treatment of patients who cannot, should not or will not take medication by mouth or injection. In addition to Topiglan, MacroChem is developing three other SEPA-enhanced drugs: Opterone(TM), a SEPA-enhanced testosterone for men with diminished levels of this sex hormone; EcoNail(TM), a SEPA-enhanced antifungal nail lacquer to treat a common and potentially debilitating nail infection known as onychomycosis; and SEPA-enhanced ibuprofen-class drugs for international marketing to people with local muscular aches and pains.
* Mr. DeLuccia, a member of the MacroChem board of directors since 1999, was elected interim CEO of MacroChem today, replacing Robert J. Palmisano, who resigned to pursue a new opportunity. (Editors: See release today announcing DeLuccia appointment)
With the exception of historical information contained in this press release, the matters described herein are forward-looking statements and are subject to various risk factors that could cause actual results to differ materially from those expressed in the forward-looking statements. The relevant risk factors are set forth in MacroChem's annual report on Form 10-K as filed with the SEC and include, without limitation, risks regarding product development, clinical trials, dependence on third parties for development and licensing arrangements, and risks involving regulatory approval of products, and patents and licenses.
Visit our web site at: www.macrochem.com
Contact: Bernard Patriacca, VP/CFO
(781)862-4003
SOURCE MacroChem
Bernard Patriacca, VP/CFO of MacroChem, +1-781-862-4003
www.macrochem.com
MacroChem Receives Clearance to Resume Clincial Trials of Topical Ed Treatment & Other Enhanced-Absorption Pharmaceuticals
THURSDAY, APRIL 10, 2003 11:06 AM
- PR Newswire
LEXINGTON, Mass., Apr 10, 2003 /PRNewswire-FirstCall via COMTEX/ -- MacroChem Corporation (MCHM) announced today that the U.S. Food & Drug Administration has lifted its October 2002 clinical hold on human trials of topical drugs utilizing the company's patented drug-absorption enhancer, SEPA(R). The clinical hold release does not impose any SEPA dosage or regimen constraints on subsequent trials, which MacroChem plans to restart as soon as possible.
The FDA had imposed a hold on human testing of drugs containing SEPA, pending review of questions surrounding a 26- week transgenic-mouse (Tg.AC) carcinogenicity study of SEPA performed by MacroChem in 1999. In releasing that hold, the FDA has requested additional information on that 1999 study, and MacroChem has agreed to provide it.
"Soon after the FDA issued its hold, MacroChem convened a panel of seven independent experts in Tg.AC testing, carcinogenicity and toxicology," explained Robert J. DeLuccia, interim president and chief executive officer of MacroChem.*
"MacroChem's independent experts reviewed documentation not only on our Tg.AC study, but in addition, our 2-year rat study and our portfolio of other laboratory studies," Mr. DeLuccia said.
At the panel's recommendation, MacroChem performed additional lab studies, including a limited irritation study in Tg.AC mice, and microscopic evaluation of certain mouse skin specimens from the first study. The experts also drew on their knowledge of the literature on transgenic animal testing, and guided MacroChem to publications on Tg.AC studies that support MacroChem's position concerning interpretation of the 1999 Tg.AC study.
"The work of our independent experts and our staff over the past few months was presented to the complete Carcinogenicity Assessment Committee (CAC) of the FDA on March 17," Mr. DeLuccia said.
"Following our presentation, the FDA released the hold on human testing of SEPA-containing drugs, without dosage or regimen restraint. The FDA has asked us to provide it with additional analysis from our 1999 Tg.AC study, in order to determine if an additional animal study might be necessary. MacroChem will continue to work with the FDA to address their questions."
"Obviously, we have lost some valuable time since the imposition of the clinical hold," Mr. DeLuccia observed, "but we're back on track now."
"Continuing discussions with physicians and licensing prospects indicates continued interest in a truly topical ED treatment like our Topiglan. We are not aware of any topical alternatives closer to commercialization than ours, to compete in this multi-billion-dollar potential market."
MacroChem develops drugs utilizing SEPA to permit delivery through skin and nail of drugs ordinarily blocked by the barrier function of those tissues. Delivery through skin can minimize the side effects of some medications, and can enable better treatment of patients who cannot, should not or will not take medication by mouth or injection. In addition to Topiglan, MacroChem is developing three other SEPA-enhanced drugs: Opterone(TM), a SEPA-enhanced testosterone for men with diminished levels of this sex hormone; EcoNail(TM), a SEPA-enhanced antifungal nail lacquer to treat a common and potentially debilitating nail infection known as onychomycosis; and SEPA-enhanced ibuprofen-class drugs for international marketing to people with local muscular aches and pains.
* Mr. DeLuccia, a member of the MacroChem board of directors since 1999, was elected interim CEO of MacroChem today, replacing Robert J. Palmisano, who resigned to pursue a new opportunity. (Editors: See release today announcing DeLuccia appointment)
With the exception of historical information contained in this press release, the matters described herein are forward-looking statements and are subject to various risk factors that could cause actual results to differ materially from those expressed in the forward-looking statements. The relevant risk factors are set forth in MacroChem's annual report on Form 10-K as filed with the SEC and include, without limitation, risks regarding product development, clinical trials, dependence on third parties for development and licensing arrangements, and risks involving regulatory approval of products, and patents and licenses.
Visit our web site at: www.macrochem.com
Contact: Bernard Patriacca, VP/CFO
(781)862-4003
SOURCE MacroChem
Bernard Patriacca, VP/CFO of MacroChem, +1-781-862-4003
www.macrochem.com
Liefern sich nen Rennen mit GPC.
Gruss E.
Gruss E.
Noch nix eingetrudelt. Ich gebe aber zu, GPC Biotech ist besser gelaufen.
Gruss E.
MACROCHEM CORP - Nasdaq National Market: MCHM
Consolidated Real-time Market Quote*
| Last | Change (%) | After Hours Chg (%)** | Bid | Ask | Trade Time |
| 1.251 | N/A | 1.25 (20) | 1.38 (8) | 11:12 |
Exchange Quote
| Last | Change (%) | Bid (size) | Ask (size) | Trade Time |
| 1.38 | 1.33 (32) | 1.38 (30) | 10:53 | |
| Day Volume | Last Size | Open | High | Low |
| 258,138 | 1,000 | 1.29 | 1.46 | 1.15 |
| Latest Ticks | # of Trades | Avg Trade Size | VWAP | 52 Wk High |
| +=-= | 269 | 960 | 1.2964 | 2.92 |
| 52 Wk Low | Prev Close | Avg Day Vol | ||
| 0.23 | 1.02 | 67,200 |
MACROCHEM CORP - Nasdaq National Market: MCHM
Real-time ECN Quote*
Exchange Quote
Real-time ECN Quote*
| Last | Change (%) | After Hours Chg (%)** | Trade Time | Bid | Ask |
| 1.79 | 0 (0.00) | 16:15 | 0 (0) | 0 (0) |
Exchange Quote
| Last | Change (%) | Trade Time | Bid (size) | Ask (size) |
| 1.79 | 15:59 | 0.01 (1) | 611.392 (1) | |
| Latest Ticks | Prev Close | Open | Low | High |
| =--+ | 1.66 | 1.74 | 1.68 | 1.89 |
| Day Volume | Avg Day Vol | VWAP | 52 Wk Low | 52 Wk High |
| 740,937 | 636,300 | 1.7975 | 0.40 | 1.84 |
| # of Trades | Last Size | Avg Trade Size | P/E Ratio | Market Cap (mil) |
| 1,117 | 300 | 663 |
Macrochem anti-impotence cream fails in study
Wednesday April 14, 4:56 pm ET
NEW YORK, April 14 (Reuters) - MacroChem Corp. (NasdaqSC:MCHM - News) on Wednesday said its experimental topical cream to treat impotence failed to meet the
primary goal of a mid-stage clinical trial.
The Lexington, Massachusetts company, which does not yet have any products on the market, said it was disappointed by the preliminary results but planned to further analyze the study's data for its drug Topiglan.
Truth is stranger than fiction, because fiction has to make sense
Wednesday April 14, 4:56 pm ET
NEW YORK, April 14 (Reuters) - MacroChem Corp. (NasdaqSC:MCHM - News) on Wednesday said its experimental topical cream to treat impotence failed to meet the
primary goal of a mid-stage clinical trial.
The Lexington, Massachusetts company, which does not yet have any products on the market, said it was disappointed by the preliminary results but planned to further analyze the study's data for its drug Topiglan.
Truth is stranger than fiction, because fiction has to make sense
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