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Peregrine Pharmaceuticals' Bavituximab Achieves Primary Endpoint in First Stage of Phase II Lung Cancer Study
Date:2/4/2009

-Preliminary Data Show Seven of 17 Evaluable Patients Achieved an Objective Tumor Response by End of Four Treatment Cycles-

TUSTIN, Calif., Feb. 4 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today reported that its lead product candidate bavituximab achieved the primary efficacy endpoint in the first stage of its ongoing Phase II clinical trial in patients with non-small cell lung cancer (NSCLC). The open-label, Simon two-stage study is designed to evaluate the safety and efficacy of the combination of bavituximab with the chemotherapy drugs carboplatin and paclitaxel in NSCLC patients. Seventeen of the 21 patients enrolled in Stage A were deemed evaluable for tumor response by the end of four treatment cycles, with six patients achieving partial tumor responses and one patient achieving a complete tumor response, according to RECIST criteria. These preliminary results exceed the pre-specified benchmark criteria established for enrolling an additional 28 patients in Stage B of this trial, up to a total of 49 patients.

"We are very pleased with the promising early results from this pilot Phase II lung cancer trial and will now move forward to initiate the second stage of the study," said Steven W. King, president and CEO of Peregrine. "We are encouraged by the number of tumor responses seen at this early time point of approximately 12 weeks in patients with NSCLC, a leading cause of cancer deaths that responds poorly to current treatments. As these patients continue on treatment, we will be assessing them for further signs of anti-tumor activity, and we look forward to sharing more data from this study as patient treatment and follow-up progress."

The primary objective of the multi-center Phase II clinical trial in patients with previously untreated locally advanced or metastatic NS
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SOURCE Peregrine Pharmaceuticals, Inc.
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