Sopherion Therapeutics, a developer and marketer of anticancer therapies, has completed enrollment in its pivotal Phase III study of nonpegylated liposomal doxorubicin, or Myocet, 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), versus paclitaxel and trastuzumab alone. Progression-free survival is the primary efficacy endpoint, with careful monitoring for cardiac safety.
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 randomization ratio.
Ronald Goldfarb, president and CEO of Sopherion, said: Myocet has the potential to be a valued addition to the treatment of metastatic breast cancer. We look forward to reporting the efficacy results from this clinical trial after the required period of follow-up.
Sopherion Therapeutics is a biotechnology company focused on developing anti-cancer therapies for patients suffering from advanced cancer, with special focus in the metastatic stage. In 2004, Sopherion entered into an exclusive licensing agreement with Zeneus Pharma now Cephalon to develop and commercialize Myocet in North America.