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Peregrine Pharmaceuticals' Bavituximab Achieves Primary Endpoint in First Stage of Phase II Breast Cancer Study
Date:2/11/2009

se II bavituximab lung cancer trial. We will continue assessing patients for anti-tumor activity as treatment and follow-up progress, and we look forward to sharing more data from these trials in the coming months."

The primary objective of this multi-center Phase II trial is to assess overall tumor response rate. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. All tumor responses in the trial are being evaluated using RECIST criteria. Patients may continue to receive bavituximab alone after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable. The trial is being conducted in India according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.

The World Health Organization reports that 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 approximately 182,460 U.S. women were diagnosed with breast cancer in 2008 and 40,480 women died of the disease in the U.S. alone.

Bavituximab is a monoclonal antibody that binds to the cellular membrane component phosphatidylserine (PS) that is usually located inside 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. By binding to PS, bavituximab is believed to help mobilize the body's immune system to destroy the tumor and the tumor blood vessels. Bavituximab currently is in two separate Phase II combination therapy trials for the treatment of advanced breast cancer and a Phase II combination therapy trial for the treatment of non-small cell lung cancer. A Phase I bavituximab monotherapy trial in advanced solid cancers is also continuing.

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SOURCE Peregrine Pharmaceuticals, Inc.
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