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 randomization ratio.
“Zoticon is delighted that Sopherion Therapeutics LLC has accomplished its recruitment objectives for the Phase III registration trial in a timely and efficient manner, which can be directly attributed to the strength and quality of its management team,” said Asher Nathan, Managing Director of Zoticon and Chairman of the Board of Sopherion Therapeutics LLC.
“Myocet has the potential to be a valued addition to the treatment of metastatic breast cancer,” said Ronald H. Goldfarb, Ph.D., President and CEO of Sopherion Therapeutics. “We look forward to reporting the efficacy results from this clinical trial after the required period of follow-up.”
About Myocet(TM) (Nonpegylated Liposomal Doxorubicin)
Myocet is a liposome-encapsulated doxorubicin-citrate complex. By encapsulating doxorubicin in a liposome — a manufactured, microscopic, vesicle consisting of discreet aqueous compartments surrounded by membranes composed of naturally occurring fats — its distribution in the body is altered in such a way as to reduce doxorubicin’s toxicity. Extensive clinical studies of Myocet in women with breast cancer have shown that the cardiac toxicity of doxorubicin can be significantly reduced, while the efficacy of the drug is maintained. This delivery system does not encompass pegylation and yields very little hand foot syndrome
About Sopherion Therapeutics, LLC
Sopherion Therapeutics, LLC is a privately-held biotechnology company based in Princeton, New Jersey. The Company is focused on developing novel anti-cancer therapies for patients suffering from advanced cancer, particularly in the metastatic stage. Sopherion is dedicated to the acquisition, discovery, development and commercialization of novel anti-cancer therapies with unique therapeutic activities that address unmet medical needs in and extend human life. In 2004, Sopherion entered into an exclusive licensing agreement with Zeneus Pharma Ltd., now Cephalon, Inc. to develop and commercialize Myocet in North America. For more information, visit http://www.sopherion.com.