Genzyme halts drug test after death(Campath)

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Genzyme halts drug test after death(Campath)

Postby Melody » Sat Sep 17, 2005 3:39 am

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 sheuser@globe.com.

© Copyright 2005 Globe Newspaper Company.

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Postby raven » Sun Sep 18, 2005 1:08 pm

As a recipient of Campath I was told of the death shortly after it happened. I now have monthly blood count tests to check for signs of the condition. If the information had been known before I commenced the trial I would still have taken part. ITP is treatable if caught early enough and I consider the benefit that I have received from treatment far outweighs any possible risk.

I really hope that this doesn't derail the licencing of Campath for MS because this stuff works!

Robin
Do not go gentle into that good night. Rage, rage against the dying of the light.
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Postby bromley » Sun Sep 18, 2005 1:29 pm

The NMSS article on Campath reports that there have been two deaths on the trial.

http://www.nationalmssociety.org/Resear ... Sept16.asp

Robin,

Glad to hear you're still doing well. Not sure what this means for those currently on the trial / have received Campath on a compassionate basis. Will you be getting a second dose next year?

Some of the press reports suggest that Campath for MS will not reach the market until after 2009 (and some say it may never reach the market because of the risks). As usual, where there is any promising treatment MS always finds a way to spoil the party (as with Antegren).

What's surprising is that the reported side effects were not seen before - Campath has been used for MS (in experiments) since the late 1980s.

All the best

Bromley
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Postby raven » Mon Sep 19, 2005 1:46 am

Hi Ian,

I don't know at this stage how this will affect me. I have my next appointment with the trial doctors early next month and will find out then.

My view is that Graves is treatable, ITP is treatable, the case of listeria was due to the participant eating unpasteurised goats cheese shortly after the infusion. The second fatality was due to unknown causes so it might not have had anything to do with Campath anyway.

MS is non-fatal but given the full range of effects that it can bring about, it might as well be as far as I'm concerned.

It would be nice if there was a simple, risk free treatment that we could take that would make this thing go away but at the moment this is not the case.

Knowing what benefits I personally have received from the treatment and also knowing the further risks that have come to light I would still sign up for Campath without hesitation.

Robin
Do not go gentle into that good night. Rage, rage against the dying of the light.
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Postby OddDuck » Mon Sep 19, 2005 4:04 am

Hi, Robin!

I'm happy to hear you're doing better these days! Keep up the good fight!

Best,

Deb
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