The Medicines Company Discontinues Phase 2b Trial of MDCO-2010
(firmenpresse) - PARSIPPANY, NJ -- (Marketwire) -- 10/04/12 -- The Medicines Company (NASDAQ: MDCO) today announced that it has voluntarily discontinued its Phase 2b dose-ranging study of MDCO-2010, a serine protease inhibitor which was being developed to reduce blood loss during surgery. This action was taken in response to serious unexpected patient safety issues encountered during the trial, which had so far recruited 44 of a planned 90 patients in the first stage of the study.
While the cause of the safety issues and any potential link to the study drug are still under investigation, the Company decided to end both the trial and further development of MDCO-2010 because of the evidence of risk to patients. The Company is conducting an in-depth assessment of all patient data from the study and any information related to drivers of risk. Once this evaluation is completed and reviewed with experts in the field, the findings will be published.
The Company has informed the regulatory agencies in Germany and in Switzerland, where patients had been enrolled into the study. In addition the Company has informed Health Canada and U.S. Food and Drug Administration, where future patient enrollment was planned. The Company will work with regulatory authorities as further information becomes available.
The dose-ranging study was the only clinical trial of MDCO-2010 currently underway. A prior Phase 2a trial met its clinical objectives with results reported in October of 2011.
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients.
Contact:
Michael Mitchell
The Medicines Company
973-290-6000
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Datum: 04.10.2012 - 21:30 Uhr
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News-ID 189898
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Biotech
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