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Sopherion has the rights to this liposomal nanotechnology that targets the tumor vasculature and has enhanced cardiac safety vs parental doxorubicin.  Moreover, Myocet™ does not display any appreciable Hand Foot Syndrome, a rate limiting toxicity for other liposomal formulations of doxorubicin. Sopherion is sponsoring a global, regulatory  Phase III Randomized, Controlled Trial of Myocet™, Trastuzumab and Paclitaxel versus Trastuzumab and Paclitaxel for First Line Therapy of Metastatic Breast Cancer.  Recruitment will be completed by 1Q 2009 and the Company plans to submit an NDA to FDA in 2010. 

Sopherion Therapeutics also has a proprietary technology platform which it has employed to discover preclinical, targeted anti-cancer agents.

 

Sopherion Therapeutics has completed recruitment for its pivotal Phase III trial

Recruitment of the Phase III trial has been completed. 363 patients who have metastatic HER-2 overexpressing breast cancer have been recruited into Sopherion’s global, multicenter study for treatment of first line metastatic breast cancer. Eligible patients were randomized to receive either MyocetTM, paclitaxel and trastuzumab (Herceptin®), or paclitaxel (Taxol) and trastuzumab alone in a 1:1 randomization ratio.

FDA-mandated 200 Patient Phase III Trial data for 200 patients reviewed on 6/30/08

Conclusions: The trial should continue as planned and cardiac safety analysis based upon blinded, independent review of cardiac imaging studies failed to demonstrate any evidence of protocol-defined cardiotoxicity.

Marcel Rozencweig, M.D. joins Sopherion Therapeutics as Senior Executive VP for Clinical Affairs

Prior to joining Sopherion, Dr. Rozencweig had been a key Clinical Development Consultant to the Company and a member of the Sopherion Protocol Development Team for Myocet.

 

 

 

  

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