PRINCETON, N.J., March 18 /PRNewswire/ -- Sopherion Therapeutics, LLC, a biopharmaceutical company focused on the development and commercialization of anti-cancer therapies, announced that it completed enrollment in its pivotal Phase III study of nonpegylated liposomal doxorubicin (Myocet(TM)) in metastatic HER-2-overexpressing breast cancer. This is a pivotal Phase III trial of Sopherion's lead product in combination with the current standard of care, paclitaxel (Taxol) and trastuzumab (Herceptin(R)), vs. paclitaxel and trastuzumab alone. Progression-free survival (PFS) is the primary efficacy endpoint, with careful monitoring for cardiac safety.
Dr. Jose Baselga, Chairman & Professor of Medicine, Vall d'Hebron Institute of Oncology (V.H.I.O.), Vall d'Hebron University Hospital in Barcelona, Spain, and principal investigator for the trial, said, "I am pleased to see that the recruitment phase of the Phase III trial has now been completed. This registration trial is based on our recently published, Roche-supported study conducted by the Spanish Breast Cancer Cooperative Group (SOLTI). Results showed that Myocet, in combination with trastuzumab and paclitaxel treatment, yielded an unusually high clinical response rate and time to progression in patients with HER-2 overexpressing breast cancer; the 3 drug combination was well tolerated with no cases of treatment-related symptomatic congestive heart failure. "
Phase III Study Design
The study is a global, randomized, multicenter pivotal Phase III study in 363 patients who have metastatic HER-2-overexpressing breast cancer. Eligibility criteria included no prior chemotherapy for metastatic disease, nor any trastuzumab, anthracyclines or taxanes within the previous 12 months. Eligible patients were randomized to receive either Myocet, paclitaxel and trastuzumab, or paclitaxel and trastuzumab alone in a 1:1 randomiza
|SOURCE Sopherion Therapeutics, LLC|
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