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Peregrine Pharmaceuticals Completes Planned Patient Enrollment in Bavituximab Phase I Cancer Trial
Date:6/30/2009

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The objectives of this multi-center open label dose escalation study are to determine the safety and tolerability of bavituximab in patients with advanced cancer, to characterize the pharmacokinetic profile of bavituximab and to identify dose-limiting toxicities and the maximum tolerated dose and/or maximum effective dose. The trial enrolled patients with breast, colorectal, pancreatic, liver, prostate, and head and neck cancers, as well as melanoma and mesothelioma. With planned enrollment complete, patient dosing and follow-up are continuing.

Bavituximab is a monoclonal antibody with a unique mechanism that enables the body's own immune system to recognize and act on the tumor and its supporting blood vessels, resulting in anti-cancer effects. Bavituximab is currently also being tested in combination with chemotherapy in one Phase II trial in advanced lung cancer and two Phase II trials in advanced breast cancer. All three trials, which have a two-stage design, surpassed the initial efficacy criteria need to expand patient enrollment. Interim results in these trials were very encouraging, with objective tumor response rates that compare favorably to chemotherapy alone. Enrollment is now complete in one of the Phase II breast cancer studies and is continuing in the other two Phase II cancer trials.

About Phosphatidylserine (PS)-Targeting Agents

The rapid and disorganized growth that is the hallmark of cancer results in the exposure of the lipid phosphatidylserine (PS) on the surface of tumor blood vessels. Since these phospholipids are typically not exposed on the surface of normal tissues, they represent a unique target for anti-cancer treatments. Bavituximab is a monoclonal antibody that binds specifically to these phospholipids exposed on the surface of the cells lining tumor blood vessels. Once bound, bavituximab alerts the body's immune system to attack the tumor blood ve
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SOURCE Peregrine Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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