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Pixantrone to be Studied in Phase I/II Trial for Aggressive Multiple Sclerosis
Date:3/5/2008

Preclinical profile and potential for lower cardiac toxicity drives

investigator interest

SEATTLE, March 6 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that its investigational drug pixantrone will be studied in a multicenter phase I/II trial initiated by the Fondation Charcot Stichting, in Brussels, Belgium, which sponsors a consortium of centers involved in studying new therapies for the treatment for multiple sclerosis. This study will enroll patients with aggressive relapsing remitting (RR) or secondary progressive (SP) multiple sclerosis (MS). Mitoxantrone, a related compound which is less active in preclinical studies, has been approved by the U.S. Food and Drug Administration (FDA) for the reduction of neurological disability and/or frequency of clinical response in patients with SP MS. A phase III trial with pixantrone in relapsed aggressive non-Hodgkin's lymphoma (NHL) is near completion.

"Despite the availability of newer biologic agents, drugs such as mitoxantrone remain an important therapy in relapsing MS. Long term cardiotoxicity remains a major drawback to treating multiple sclerosis with mitoxantrone and imposes a limitation both for selection of patients and for the duration of the treatment," said R.E. Gonsette, M.D., Chairman Fondation Charcot Stichting and principal investigator of the study. "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."

The investigator-sponsored trial (IST) will enroll 20 patients in Belgium, France and Germany.

About the Study

Twenty patients with aggressive RR MS or SP MS who failed to respond to approved immunomodulatory agents (interferons, glatiramer acetate) will be included. The objectives of the study are to determine the
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SOURCE Cell Therapeutics, Inc.
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