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Peregrine Pharmaceuticals Doses First Patient in Phase II Trial of Bavituximab in Patients With Advanced Breast Cancer
Date:8/11/2008

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) standards.

Peregrine recently reported that a Phase II trial assessing the combination of bavituximab and docetaxel in patients with metastatic breast cancer had achieved the pre-specified Stage A primary endpoint needed to expand the trial to the second stage. Seven of the 14 evaluable patients achieved partial tumor responses and seven had stable disease at week eight according to RECIST criteria.

"Bavituximab showed promising signs of anti-tumor activity in metastatic breast cancer patients in combination with chemotherapy in a clinical study we helped conduct last year," said Dr. Raghunadharao Digumarti, professor of medical oncology at the Nizams Institute of Medical Sciences in Hyderabad, India and a principal investigator of the bavituximab Phase II breast cancer trial. "We look forward to assessing the results from this trial in a larger population of patients with breast cancer, the most commonly diagnosed cancer in women worldwide."

According to the World Health Organization, 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 will be diagnosed with breast cancer in 2008 and 40,480 women will die of the disease.

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 dest
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SOURCE Peregrine Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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