Phase II trial resumes
Posted: Thu May 17, 2007 1:11 am
Genzyme gets OK to resume testing of MS drug 17 May 2007
Patient in trial died of bleeding in the brain.
The Food and Drug Administration will allow Genzyme Corp. to continue human tests of a new multiple sclerosis drug that caused a fatal bleeding disease in one trial patient, the company said yesterday.
The drug, Campath, is a cancer treatment that has showed promise as a once-a-year infusion for multiple sclerosis patients.
Compared to a standard MS drug, Campath sharply reduced the number of disabling relapses suffered by patients in a clinical trial. But in 2005, Genzyme disclosed that one patient on Campath had died of bleeding in the brain. The Cambridge company voluntarily suspended its clinical testing of Campath and put a tight surveillance system in place to watch for symptoms of the bleeding disorder.
At a meeting of financial analysts in Boston yesterday, a Genyzme executive said the FDA had lifted the suspension. He said the clinical trial so far has yielded five other cases of the bleeding disorder, called immune thrombocytopenic purpura , or ITP. All of those patients were treated and recovered. With early detection and treatment, the problem amounts to a "manageable risk" for Campath patients, said the company.
Although the trial was effectively complete before the suspension, the lifting of the suspension allows Genzyme to move ahead in discussions with the FDA on two larger trials of Campath. Genzyme expects to launch those trials later this year.
Source: Boston.com © 2007 The New York Times Company (17/05/07)
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Patient in trial died of bleeding in the brain.
The Food and Drug Administration will allow Genzyme Corp. to continue human tests of a new multiple sclerosis drug that caused a fatal bleeding disease in one trial patient, the company said yesterday.
The drug, Campath, is a cancer treatment that has showed promise as a once-a-year infusion for multiple sclerosis patients.
Compared to a standard MS drug, Campath sharply reduced the number of disabling relapses suffered by patients in a clinical trial. But in 2005, Genzyme disclosed that one patient on Campath had died of bleeding in the brain. The Cambridge company voluntarily suspended its clinical testing of Campath and put a tight surveillance system in place to watch for symptoms of the bleeding disorder.
At a meeting of financial analysts in Boston yesterday, a Genyzme executive said the FDA had lifted the suspension. He said the clinical trial so far has yielded five other cases of the bleeding disorder, called immune thrombocytopenic purpura , or ITP. All of those patients were treated and recovered. With early detection and treatment, the problem amounts to a "manageable risk" for Campath patients, said the company.
Although the trial was effectively complete before the suspension, the lifting of the suspension allows Genzyme to move ahead in discussions with the FDA on two larger trials of Campath. Genzyme expects to launch those trials later this year.
Source: Boston.com © 2007 The New York Times Company (17/05/07)
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