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Peregrine Pharmaceuticals Reports 61% Objective Response Rate in 46-Patient Bavituximab Phase II Trial in Advanced Breast Cancer
Date:10/21/2009

TUSTIN, Calif., Oct. 21 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHMD) today reported positive results from its Phase II trial evaluating bavituximab in combination with docetaxel in patients with advanced breast cancer. Preliminary data at the end of the six planned treatment cycles in the Phase II study showed that 28 of 46, or 61%, of all patients enrolled in the trial achieved an objective tumor response according to RECIST criteria. This data compares favorably with data from a published study showing an objective tumor response rate of 41% in a similar patient population receiving the same dosing regimen of docetaxel administered as a single agent.

Joseph Shan, vice president of clinical and regulatory affairs at Peregrine commented, "We are very encouraged by the initial results reported today for the full 46 patients enrolled in the bavituximab plus docetaxel Phase II trial. The tumor response data reported in this study exceeded the tumor response data for docetaxel alone that was used as the benchmark for the design of this study. With these positive initial data in hand, we and our expert advisors believe that this combination regimen warrants further clinical evaluation, and we are now assessing possible trial designs for future studies."

The primary objective of the multi-center, open-label Phase Il study is to assess the overall response rate to bavituximab and docetaxel. In this trial's Simon two-stage design, 15 patients were initially enrolled in the study followed by an additional 31 patients after the pre-specified primary efficacy endpoint for expanding the study was met, bringing the total to 46 patients. Initial data from the first set of 15 patients in the study was reported in an oral presentation at the 2009 ASCO Annual Meeting. Recent analysis showed the median progression-free-survival (PFS) of patients enrolled in the initial 15-patient cohort of the study was 7.4 mo
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SOURCE Peregrine Pharmaceuticals, Inc.
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