Peregrine Pharmaceuticals Submits Clinical Protocol for New Phase II Trial of Bavituximab in Patients With Metastatic Bre...( TUSTIN Calif. Oct. 22 /- Peregrin...),Health

TUSTIN, Calif., Oct. 22 /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 Phase II clinical protocol with the Ministry of Health of the Republic of Georgia to study bavituximab in combination with the chemotherapy drug docetaxel in patients with metastatic breast cancer. The open label, multi-center safety and efficacy trial will begin enrolling patients pending regulatory and ethics committee approvals.

The new 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 docetaxel, a chemotherapy drug commonly used in the treatment for metastatic breast cancer. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. The study is expected to enroll patients at a minimum of three clinical trial sites.

"The filing of this second breast cancer protocol continues our strategy of evaluating bavituximab in Phase II combination studies in specific cancer indications," said Steven W. King, president and CEO of Peregrine. "This study also marks our first clinical initiative in Eastern Europe, which has become a major venue for global clinical trials conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) standards. The sites we are
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