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Peregrine Pharmaceuticals' Bavituximab Achieves Primary Endpoint in First Stage of Phase II Breast Cancer Study
Date:2/11/2009

--Preliminary Data from Ongoing Study Shows Seven of 14 Evaluable Patients Achieved Objective Tumor Response by the End of Two Treatment Cycles--

--Bavituximab Has Now Produced Positive Early Results in All Three Ongoing Phase II Combination Therapy Cancer Trials--

TUSTIN, Calif., Feb. 11 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today reported that its lead product candidate bavituximab achieved the pre-specified Stage A primary endpoint in an ongoing Phase II clinical trial in patients with advanced breast cancer. The Phase II trial is an open-label, Simon two-stage design to evaluate the safety and efficacy of bavituximab in combination with the chemotherapy drugs carboplatin and paclitaxel in locally advanced or metastatic breast cancer patients. Fourteen of the 15 patients enrolled in Stage A were deemed evaluable for tumor response, with seven patients achieving an objective response by approximately eight weeks, after completing two treatment cycles. Six of the patients achieved partial tumor responses and one patient achieved a complete tumor response, according to RECIST criteria.

With the Stage A pre-specified primary endpoint achieved, the design of the clinical trial allows for an additional 31 study patients to be enrolled.

"We have now achieved early success in all of our ongoing Phase II bavituximab cancer trials, surpassing our pre-specified primary endpoint criteria for the number of patients achieving an objective tumor response in each of the three clinical studies, " said Steven W. King, president and CEO of Peregrine. "The results reported today reinforce the positive early data seen in our Phase II breast cancer trial assessing bavituximab in combination with docetaxel, as well as the promising early data we reported last week from our Pha
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SOURCE Peregrine Pharmaceuticals, Inc.
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