Peregrine Pharmaceuticals Reports Positive Early Results in Phase II Study of Bavituximab in Bre...( - Pre-Specified Primary Efficacy Endp...),Health

- Pre-Specified Primary Efficacy Endpoint Met in Stage 1 of Two-Stage Study

- - 100% of Evaluable Patients to Date Continue to Show Objective Tumor

Response or Stable Disease -

TUSTIN, Calif., July 2 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today reported that its lead product candidate bavituximab achieved the pre-specified Stage 1 primary endpoint in its ongoing Phase II clinical trial in patients with metastatic breast cancer. The trial is an open-label, Simon two-stage design to evaluate the safety and efficacy of a combination of bavituximab and docetaxel in metastatic breast cancer patients. Fourteen of the 15 patients enrolled in Stage 1 were deemed evaluable for tumor response, with seven achieving partial tumor responses and seven having stable disease at week eight according to RECIST criteria. All 14 of the evaluable patients remain in the study and are continuing to receive treatment, along with continuing assessments of tumor response. With the Stage 1 primary endpoint of six or more objective tumor responses achieved, the design of the clinical trial now allows for an additional 31 study patients to be enrolled.

"We are very pleased with the early positive results from this Phase II breast cancer study," said Steven W. King, president and CEO of Peregrine. "We are particularly encouraged by the fact that at an early time point of eight weeks, half of the patients had achieved objective tumor responses. Equally encouraging is that with patients now out over four months since the start of the study, none have shown tumor growth or disease progression. As these patients continue on treatment, we will continue assessing
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