MS'ers have gotten used to a "two steps forward and one step back" rate of progress over the past year, accentuated by the Tysabri-PML issue. The trend continues with Genzyme's Campath therapy, which reported good results, but serious side effects that will require the trials to be put on hold indefinitely while more stringent safety standards are put into place.
Campath is a cancer treatment that is currently approved to treat the rare cancer called B-cell chronic lymphocytic leukemia. Trials in MS have shown promise-- and in this latest round of results, Campath patients were only 25% as likely to have a relapse of symptoms as patients taking the interferon Rebif. Campath also showed some indicators of slowing long-term disease progression, but not enough to be seen as statistically significant.
Unfortunately with the two steps forward, comes one back: There were 3 serious adverse events reported, with one of those leading to a patient death. 3 of 219 MS patients dosed with Campath were diagnosed with a blood condition called idiopathic thrombocytopenic purpura, a highly dangerous drop in blood platelets that help clot wounds.
This possible side-effect is already on the label for the cancer treatment indication. The patient who died had shown symptoms of the condition for a month before seeking medical care. The other two patients were diagnosed more quickly and are responding to treatment.
Genzyme said it intends to continue testing the drug, but only after working with regulators to improve the safety of the trials. Obvious changes include monitoring patients more closely, as well as instructing them to look for symptoms of the blood condition before it becomes irreversible.
And so the dance continues...
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