Genzyme halts drug test after death
Three MS patients in Campath trial get blood disorder
By Stephen Heuser, Globe Staff | September 17, 2005
Genzyme Corp. said yesterday that it has halted an experimental treatment for multiple sclerosis after three patients contracted a rare bleeding disorder and one of them died.
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Sign up for: Globe Headlines e-mail | Breaking News Alerts The company was testing Campath, a drug currently used to treat leukemia, on patients with multiple sclerosis.
Campath appeared to alleviate MS symptoms and showed signs that it might be able to halt long-term damage from the disease. But in some patients, it also triggered a dangerous drop in blood platelets, the cells that help the body clot and seal wounds.
Three of 219 MS patients given the drug were diagnosed with the blood condition, called idiopathic thrombocytopenic purpura. Genzyme said it will not give Campath to patients until the safety issue can be resolved.
''Multiple sclerosis is a very serious disease, and you don't want any deaths," Dr. Richard Moscicki, the Cambridge company's chief medical officer, said yesterday.
Moscicki said the patient who died had shown symptoms of the condition for a month without seeking medical care. The other two patients were diagnosed more quickly and are responding to treatment, he said.
Genzyme said it intends to continue testing the drug after working with regulators to improve the safety of the trials, but it will monitor patients more closely and instruct them to look for symptoms of the blood condition.
Campath is one of two cancer drugs Genzyme acquired last year when it bought Ilex Oncology Inc., a Texas company, for $1 billion. Ilex had already started the multiple sclerosis trial. Under the deal, Campath is owned by Genzyme but sold by the German drug company Schering AG.
The test was designed to measure the effectiveness of Campath in comparison with Rebif, a drug now on the market to treat MS symptoms, which can include numbness, vision problems, and disorientation.
After analyzing data from the first year of the planned three-year trial, Genzyme said patients on Campath were only one-quarter as likely to have a relapse of symptoms as those taking Rebif. It also showed some signs of slowing long-term damage, though not enough to be statistically significant.
Campath is approved only to treat a rare cancer called B-cell chronic lymphocytic leukemia. If it is approved to treat multiple sclerosis, sales could increase dramatically. The National Multiple Sclerosis Society estimates that approximately 400,000 people in the United States have MS.
An analyst said yesterday that the news was unlikely to have an immediate effect on the company's financial picture because Campath probably would not receive approval as an MS treatment before 2009.
''I think the data are intriguing because the efficacy seemed to be very strong," said Phil Nadeau, a biotechnology analyst for SG Cowen. ''It's now up to the company to better define the safety of the compound."
Stephen Heuser can be reached at email@example.com
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John was diagnosed Jan 2005. On lipitor 20mg .On Copaxone since July 4,2005. Vitamin D3 2000iu-4000iu (depending on sunshine months)June 10 2005(RX::Dr. O'Connor) Omega 3 as well Turmeric since April 2005. Q10 60mg. 1500mg liquid Glucosamine Nov 2005.