Peregrine to Begin Phase II Trial of Bavituximab

Peregrine Pharmaceuticals’ Phase II clinical protocol to study bavituximab in combination with the chemotherapy drug docetaxel in patients with metastatic breast cancer has been approved by the Drug Agency of the Ministry of Labor, Health and Social Affairs of Georgia.

The open-label, multicenter safety and efficacy trial is expected to begin enrolling patients in early 2008.

The primary objective of the trial is to assess the overall response rate to the combination of bavituximab with docetaxel, a chemotherapy drug commonly used in the treatment of metastatic breast cancer. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters.

Up to 15 patients with metastatic breast cancer will be enrolled initially. The study will expand to include 46 patients if promising results are observed, Peregrine said.