Cell Therapeutics and IDIS Announce Agreement for a European Named Patient/Compassionate Use Program for ... (assessment panel that was blinded to the...)

Cell Therapeutics and IDIS Announce Agreement for a European Named Patient/Compassionate Use Program for Pixantrone

Date:2/10/2009

assessment panel that was blinded to the treatment assignments.

The most common serious toxicities (>5%) seen in previous trials of pixantrone include grade 3 and 4 neutropenia and febrile neutropenia. Complete safety information is not yet available for the study, however, the study was monitored on an ongoing basis by an independent Data Safety Monitoring Committee and no serious concerns were raised.

The study received Special Protocol Assessment approval from the U.S. Food and Drug Administration (FDA) in 2004 and pixantrone has received fast track designation for this indication.

About Pixantrone

Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy. Pixantrone is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy 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 IDIS

IDIS is the world leader in the development and implementation of named patient programs and has a proven track record of working in strategic partnership with US-based companies to bring new drugs to Europe for the first time. IDIS supports customers in over 100 countries, supplying more than 400 different medicines per m
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SOURCE Cell Therapeutics, Inc.
Copyright©2009 PR Newswire.
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Cell Therapeutics and IDIS Announce Agreement for a European Named Patient/Compassionate Use Program for ...(assessment panel that was blinded to the...),Health