Friday, September 16, 2005
New MS Drug on the Horizon?
Here we go again:
- A drug from Genzyme Corp. and Schering AG helped reduce the risk of relapses in multiple sclerosis patients, but caused a serious side effect in three cases that led to a death, the companies said Friday."
In the Phase II or mid-stage trial, three patients developed idiopathic thrombocytopenic purpura, or ITP, a condition in which patients experience a low platelet count that can result in bruising easily and abnormal bleeding after being injured.
One patient died from the condition. Two remaining cases are being treated.
- Genzyme executives characterized the condition as reasonably manageable. Treatments include steroids, and in some cases, removal of the spleen.
- Genzyme and Schering said they have notified regulatory authorities in the United States and other countries, trial sites and patients about risks. The companies have consulted a panel of experts to advise the companies on how to reduce risks of ITP.
<...>
The companies said they will continue to collect both efficacy and safety data from this Phase II trial -- which compared Campath (alemtuzumab) with Rebif, a drug from Switzerland’s Serono -- while preparing to initiate a Phase III trial.
While Campath met one of its key goals, reducing relapse, it just missed a second, which was to show a statistically significant reduction in the risk of progression of clinically significant disability.
The drug, however, did show signs of reducing the progression of disability, with at least 60 percent of patients experiencing a benefit.
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