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Peregrine Pharmaceuticals Announces Bavituximab Phase II Trial

September 10, 2007

Peregrine Pharmaceuticals reported that it has submitted a clinical protocol to the Drug Controller General of India 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.

Peregrine said it expects to begin enrolling patients in the multicenter trial pending regulatory and ethics committee approvals.

Approximately 15 patients will be enrolled initially and the study will be expanded to a maximum of 46 patients if promising results are observed in the first group. The primary objective is to assess the overall response rate, and secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters, the company said.

Patients may continue to receive weekly administration of the combination as long as their cancer does not progress, unless side effects require earlier cessation of therapy, the company added.