Posted by: Thixia | March 9, 2008

Phase I/II Trial For Aggressive Multiple Sclerosis

Pixantrone To Be Studied In Phase I/II Trial For Aggressive Multiple Sclerosis

Biopharmaceutical Company Cell Therapeutics, Inc. that its new drug pixantrone would be studied in a multicenter phase I/II trial for treating multiple sclerosis. The company intends to complete a phase III trial with pixantrone in relapsed aggressive non-Hodgkin’s lymphoma soon. Cell Therapeutics noted that the U.S. Food and Drug Administration has accepted Mitoxantrone, a related compound, which is less active in preclinical studies, for the reduction of neurological disability and/or frequency of clinical response in patients with secondary progressive multiple Sclerosis (SPMS).

The study, commenced by the Fondation Charcot Stichting, in Brussels, Belgium, which sponsors a consortium of centers involved in studying new therapies, will enroll patients with aggressive relapsing remitting multiple Sclerosis (RRMS), or SPMS. Cell Therapeutics said that the study would include twenty patients with aggressive RRMS or SPMS who didn’t respond to accepted immunomodulatory agents.

According to Cell Therapeutics, the study is to decide the efficiency of pixantrone as an immunosuppressive agent on the basis of its capability to reduce the lymphocyte count and to assess the drug’s usefulness in MS based on gadolinium-enhanced magnetic resonance imaging.

The trial is an open-label, multi-center, non-comparative study of pixantrone administered at a dose of 120 mg/m2 once every 21 days, or 3 weeks. Four consecutive three-week courses of pixantrone will be supervised in order to assess if this treatment results in lymphopenia of less than or equal to 1000/mm3. The doses and the number of infusions will be modified to leukocyte, granulocyte and thrombocyte counts and perhaps reduced.

Gonsette, M.D., Chairman Fondation Charcot Stichting and principal investigator of the study, commented, “In addition to the potential for lower cardiac toxicity, preclinical studies suggest that pixantrone may provide more effective immune regulation than mitoxantrone, the only currently approved cytotoxic agent for treating MS.”

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