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PHARMACEUTICALS
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Tustin’s Peregrine Pharmaceuticals: more good news

Sixty-one percent of breast cancer patients in Phase II trial showed objective tumor response.

By Susan BelknappPublished: October 22, 2009 09:55 AM

Tustin-based Peregrine Pharmaceuticals Inc. reported Wednesday its Phase II trial evaluating bavituximab in combination with docetaxel in patients with advanced breast cancer showed very promising results.

Preliminary data at the end of six planned treatment cycles in the Phase II study showed that 28 of 46, or 61 percent, of all patients enrolled in the trial achieved an objective tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. The data compares favorably with that from a published study showing an objective tumor response rate of 41 percent in a similar patient population receiving the same dosing regimen of docetaxel administered as a single agent.

"We are very encouraged by the initial results reported today for the full 46 patients enrolled in the bavituximab plus docetaxel Phase II trial,” says Joseph Shan, vice president of clinical and regulatory affairs at Peregrine. “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."

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