Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Bre...( TUSTIN Calif. Sept. 10 /- Peregri...),Health

TUSTIN, Calif., Sept. 10 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced that it has submitted a clinical protocol with the Drug Controller General of India (DCGI) for an open label Phase II safety and efficacy trial of bavituximab in combination with the chemotherapy drugs paclitaxel and carboplatin in patients with metastatic breast cancer. The multi-center trial is expected to begin enrolling patients pending regulatory and ethics committee approvals.

The trial has a two-stage design. Up to 15 patients with metastatic breast cancer will be enrolled initially and the study will be expanded up to a total of 46 patients if promising results are observed in the first cohort. The primary objective is to assess the overall response rate to the combination of bavituximab with doses of paclitaxel and carboplatin. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients may continue to receive weekly administration of bavituximab with weekly doses of paclitaxel and carboplatin as long as their cancer does not progress, unless side effects require earlier cessation of therapy.

"The filing of this second cancer clinical protocol reflects our strategy of fielding a number of targeted Phase II combination studies in specific cancer indications," said Steven W. King, president and CEO of Peregrine. "Despite advances in treatment, breast cancer remains a major source of mortality among women. We designed this study using data generated from our recen
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