Peregrine initiates Ph II bavituximab study

The USA's Peregrine Pharmaceuticals says that patient screening and dosing has begun in a Phase II trial designed to evaluate the safety and efficacy of bavituximab in combination with chemotherapy in patients with advanced breast cancer.

The new trial is the second mid-stage study evaluating bavituximab for this disease, and Peregrine is also conducting a third combination therapy trial of the drug in non-small cell lung cancer patients. The primary objective of the new breast cancer study is to assess the overall tumor response rate to the combination of bavituximab with carboplatin and paclitaxel.

In the trial's two-stage design, up to 15 patients with advanced breast cancer will be enrolled initially. The study will then be expanded up to a total of 46 subjects if promising results are observed. Secondary objectives of the trial include measuring time-to-tumor progression, duration of response, overall patient survival and safety parameters. Tumor response will be evaluated using Response Evaluation Criteria in Solid Tumors parameters. Patients may continue to receive bavituximab alone after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable.