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.
Approximately 14 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.
Steven King, president and CEO of Peregrine, said: “We are very pleased with the early positive results from this Phase II breast cancer study. We look forward to sharing more data from this study as patient treatment and follow-up progress.”