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Sopherion Therapeutics, LLC Announces Publication of Phase I/II Myocet(R) (Nonpegylated Liposomal Doxorubicin) Data in Advanced Breast Cancer Patients
Date:2/5/2009

PRINCETON, N.J., Feb. 5 /PRNewswire/ -- Sopherion Therapeutics, LLC, a biopharmaceutical company focused on the development and commercialization of anti-cancer therapies, today announced the publication of data from a phase I/II study of nonpegylated liposomal doxorubicin (Myocet(R)) in the January 1 issue of Clinical Cancer Research. The study was supported by a grant from Roche and was conducted by the Spanish Breast Cancer Cooperative Group (SOLTI).

The study results suggest that Myocet(R), in combination with the approved trastuzumab (Herceptin(R)) plus paclitaxel (Taxol) treatment regimen, yielded an unusually high clinical response rate in patients with HER-2 overexpressing breast cancer. The 3-drug combination was well tolerated. There were no cases of treatment-related symptomatic congestive heart failure. This is noteworthy because cardiotoxicity is a common and therapy-limiting adverse event of the anthracycline class of anti-cancer agents and because Herceptin(R) has its own, well recognized, potential for cardiac toxicity.

Myocet is a liposomal delivery system for doxorubicin designed to reduce the risk of cardiotoxicity associated with doxorubicin while preserving its antitumor efficacy. It is currently in Phase III development in the United States for the treatment of advanced breast cancer.

"These clinical results are encouraging because they suggest that use of a nonpegylated liposomal anthracycline, such as Myocet, may provide important therapeutic benefits, while diminishing cardiac toxicity," said Ronald H. Goldfarb, Ph.D., President and CEO of Sopherion Therapeutics. "Moreover, the incidence of hand foot syndrome, a rate limiting toxicity of other liposomal anthracyclines, is rare with nonpegylated liposomal anthracyclines. We look forward to reporting additional data from ongoing Myocet clinical trials, which further test this concept in patients with advanced breast cancer."<
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SOURCE Sopherion Therapeutics, LLC
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