The Medicines Company discontinues phase IIb trial

Friday, October 5, 2012 02:27 PM

The Medicines Company has voluntarily discontinued its phase Iib, dose-ranging study of MDCO-2010, a serine protease inhibitor 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 so far had 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 regulatory agencies in Germany and in Switzerland, where patients had been enrolled into the study. In addition, the company has informed Health Canada and the FDA, since patient enrollment was planned in both countries. 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 IIa trial met its clinical objectives, with results reported in October 2011.

Share:          
CWWeekly

April 13

Quintiles-Quest Diagnostics joint venture latest in CRO-central lab deals, more could be on horizon

Biotech companies raise record amount of capital in Q1

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

Already a subscriber?
Log in to your digital subscription.

Purchase the February issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs