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Peregrine Pharmaceuticals Submits Clinical Protocol for New Phase II Trial of Bavituximab in Patients With Metastatic Breast Cancer
Date:10/22/2007

working with have solid experience in conducting mid and late stage cancer trials that adhere to FDA and international standards. We have been impressed to date by the professionalism of their operations, the efficiency of their patient recruitment infrastructure and their commitment to patient welfare."

Tumor response in this new study will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) parameters. The trial is being conducted according to ICH and GCP guidelines.

According to the World Health Organization, metastatic breast cancer is the most commonly diagnosed cancer in women, and is second only to lung cancer as a leading cause of female cancer deaths. The National Cancer Institute estimates that 178,480 U.S. women will be diagnosed with cancer of the breast in 2007 and 40,460 women will die of the disease.

Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is normally located inside normal cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. Bavituximab is believed to help mobilize the body's immune system to destroy the blood vessels needed for tumor growth and spread. In a Phase lb trial in advanced cancer patients, bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity, achieving objective response or disease stabilization in 50% of the evaluable patients. A protocol for a Phase ll trial of bavituximab in combination with the chemotherapy drugs paclitaxel and carboplatin in patients with metastatic breast cancer is currently undergoing regulatory review in India. A protocol for a Phase ll trial of bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC) is also under regulatory review in India. Bavituximab is in clinical trials in the U.S. i
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SOURCE Peregrine Pharmaceuticals, Inc.
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