The primary objective of this multi-center, open-label Phase II study is to assess the overall response rate to bavituximab and docetaxel. In the trial's two-stage design, 15 patients with advanced breast cancer were enrolled in the first cohort. The 71% objective tumor response rate seen in the 14 evaluable patients in the first cohort compares favorably with historical response rates for docetaxel as solo therapy in advanced breast cancer patients and it exceeded the pre-specified primary endpoint needed to expand the trial. An additional 31 patients were then enrolled to achieve the planned study total of 46 patients overall. With patient enrollment complete, dosing and follow-up are continuing. The safety profile of bavituximab plus docetaxel in the study has been acceptable, with minor infusion reactions, epistaxis and nasal dryness among the most common reported bavituximab-related side effects. These did not require dose modification or treatment discontinuation.
Separately, Peregrine reported that researchers will present data at ASCO today from a Phase I study assessing the safety and pharmacokinetic (PK) properties of bavituximab as monotherapy in patients with advanced refractory cancers. This multi-center open label safety study is currently enrolling patients in the final cohort according to the initial study design. The study authors report on their experience with the first 25 patients in the st
|SOURCE Peregrine Pharmaceuticals, Inc.|
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