- Completion of Phase I Paves Way for Expanding Bavituximab Cancer Program -

- Inclusion of Patients with Diverse Advanced Cancers Along with Promising Interim Phase II Data Suggest Bavituximab Could Have Broad Anti-Cancer Utility -

TUSTIN, Calif., June 30 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced that it has completed the planned patient enrollment in its U.S. Phase I clinical trial evaluating bavituximab as monotherapy in patients with advanced refractory cancers. In a presentation of preliminary data from this trial at the 2009 ASCO Annual Meeting last month, the study's principal investigator at MD Anderson Cancer Center reported that bavituximab was generally safe and well-tolerated, with a predictable pharmacokinetic profile. In these patients, a maximum tolerated dose had not been reached even at the highest planned dose level. Peregrine has now begun designing additional bavituximab cancer trials based on findings from this Phase I study and the company's ongoing Phase II combination therapy trials in breast and lung cancer.

'Completion of patient enrollment in this Phase I trial is a significant milestone for the bavituximab cancer program,' said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine. 'We believe data from this study, along with our ongoing Phase II lung and breast cancer trials, set the stage for advancing the bavituximab oncology program into later-stage clinical studies. The safety data collected from the diverse cancer types in this study are encouraging as we plan for expansion of the bavituximab cancer program in the coming year. We look forward to sharing more data from the ongoing cancer trials as patient treatment and follow-up continue in this study and in our three ongoing Phase II bavituximab cancer trials.'

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.