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Sopherion has the US and Canadian 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 Phase III Randomized, Controlled Registration Trial of Myocet™, Trastuzumab and Paclitaxel versus Trastuzumab and Paclitaxel for First Line Therapy of HER-2-over expressing Metastatic Breast Cancer.  Recruitment was completed in 1Q 2009 and the Company plans to submit an NDA to FDA in 2010. The predecessor to Sopherion Therapeutics, LLC, Sopherion Therapeutics, Inc., now SPHN Holdings, Inc. also has a proprietary technology platform which it has employed to discover preclinical, targeted anti-cancer agents.


 
 

Sopherion Therapeutics receives FDA Fast Track Designation for Myocet in Metastatic Breast Cancer

Sopherion Therapeutics has received Fast Track Designation from the U.S. FDA for nonpegylatged liposomal doxorubicin (Myocet™) for first-line therapy of HER-2-over expressing metastatic breast cancer for its Phase III global, registration trial of Myocet plus paclitaxel and trastuzumab vs. trastuzumab combined with paclitaxel.

 

Sopherion Therapeutics Completes Enrollment in Phase III Study of Myocet in Metastatic Breast Cancer

Sopherion Therapeutics, LLC completed enrollment in its pivotal Phase III study of nonpegylated liposomal doxorubicin (Myocet™) in metastatic HER-2-overexpressing breast cancer. This is a registration trial of Sopherion’s lead product in combination with the current standard of care, paclitaxel and trastuzumab vs. paclitaxel and trastuzumab alone for first line treatment of HER-2-over expressing breast cancer. PFS is the primary endpoint with careful monitoring for cardiac safety.

 

Marcel Rozencweig, M.D. joins Sopherion 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.

 

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.

       

 

 

 

 

 

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