Peregrine Completes Patient Enrollment in Cancer Combination Therapy Trial

Peregrine Pharmaceuticals has announced that enrollment of the planned 12 evaluable patients in its Phase Ib cancer trial has been completed. This trial at clinical sites in India is designed to assess the safety of bavituximab in combination with common chemotherapy agents in advanced cancer patients with metastatic disease who had failed prior therapy. Data from this study are expected to support the initiation of Phase II cancer trials later this year.

The Phase Ib open-label trial is designed to characterize the safety, tolerability and pharmacokinetics of bavituximab given in combination with standard chemotherapy regimens including docetaxel, gemcitabine and carboplatin/paclitaxel. Study patients are considered enrolled and evaluable for safety analysis after completing four of the planned eight weekly doses of bavituximab in combination with chemotherapy.

To date, the safety profile of bavituximab in combination with chemotherapy appears similar to that seen in advanced cancer patients undergoing chemotherapy treatment alone. Nine patients have completed their courses of therapy and have been assessed for tumor response. Of these, more than half achieved either disease stabilization or an objective tumor response. Both stable disease and objective response are considered potential signs of antitumor activity, according to the company. Patients demonstrating either an objective tumor response or stable disease have been offered continued treatment with the combination regimen on a compassionate use basis.

Bavituximab is a monoclonal antibody that targets and binds to a phospholipid called phosphatidylserine, which is located on the inside of normal cells but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anticancer treatments, according to Peregrine.