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

Main Category: Multiple Sclerosis
Article Date: 07 Mar 2008 - 0:00 PST



Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced 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 efficacy of pixantrone as an immunosuppressive agent based on its ability to decrease the lymphocyte count and to evaluate efficacy in MS based on gadolinium enhanced magnetic resonance imaging. This trial is an open-label, multi-center, non-comparative study of pixantrone administered at a dose of 120 mg/m2 once every 21 days (3 weeks). Four consecutive three-week courses of pixantrone will be administered in order to determine if this regimen results in lymphopenia of less than or equal to 1000/mm3. The doses and the number of infusions will be adapted to leukocyte, granulocyte and thrombocyte counts and possibly reduced.

About Pixantrone

Pixantrone (BBR 2778) is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. A new chemical compound for the treatment of non-Hodgkin's lymphoma (NHL), and various other hematologic malignancies, solid tumors, and immunological disorders, pixantrone is being developed by CTI to improve the activity and safety in treating cancers usually treated with the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.cticseattle.com.

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of pixantrone and the risks related to this clinical trial include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including, without limitation, the potential failure of pixantrone to prove safe and effective for treatment of multiple sclerosis, the identification of new risks or limitations of pixantrone that may be discovered in this Investigator Sponsored Trial, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

Cell Therapeutics, Inc.
http://www.cticseattle.com

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