Peregrine’s Phase II breast cancer trial meets primary endpoint

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.

Approximately 14 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. Approximately 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, the company said.

The primary objective of this multi-center Phase II trial is to assess overall tumor response rate. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. All tumor responses in the trial are being evaluated using RECIST criteria.

Bavituximab currently is in two separate Phase II combination therapy trials for the treatment of advanced breast cancer and a Phase II combination therapy trial for the treatment of non-small cell lung cancer. A Phase I bavituximab monotherapy trial in advanced solid cancers is also continuing.

Steven King, president and CEO of Peregrine, said: The results reported 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 from our Phase II bavituximab lung cancer trial. We will continue assessing patients for anti-tumor activity as treatment and follow-up progress, and we look forward to sharing more data from these trials in the coming months.