Bavituximab Anti-Cancer is a monoclonal antibody that targets a basic component of a cell’s membrane called phosphatidylserine (PS). Scientists working for Peregrine discovered that PS, which is normally found on the inside of healthy cell membranes, becomes exposed on the surface of tumor blood vessel cells. Bavituximab alerts the body’s immune system to attack the tumor blood vessel cells that exhibit exposed PS.

This has been shown to inhibit tumor growth and development. Bavituximab is not attracted to healthy cells in which PS is maintained on the interior of the membrane, thus the drug preferentially targets tumor blood vessels and potentially minimizes unwanted side effects. For more scientific information about bavituximab anti-cancer, click here.

Bavituximab Oncology Clinical Program

Based on encouraging data presented at the ASCO 2010 Annual Meeting, we have initiated two randomized Phase IIb NSCLC trials.

• A registrational Phase IIb trial is evaluating bavituximab combined with docetaxel in patients with refractory NSCLC. The multi-center randomized, double-blinded, placebo-controlled trial will enroll up to 120 patients.
• A randomized open-label Phase IIb trial is evaluating bavituximab plus paclitaxel and carboplatin as front-line therapy in patients with NSCLC.

Click here to learn more about these and our other clinical trials currently enrolling patients.

Peregrine is also assessing bavituximab in three open-label Phase II clinical trials in combination with chemotherapy in patients with advanced solid cancers – two in patients with advanced breast cancer and one in patients with non-small cell lung cancer (NSCLC). All patient enrollment and planned combination treatment has been completed in these trials, with encouraging preliminary results reported in all three. Patient follow-up is continuing. A Phase I bavituximab monotherapy trial in advanced solid cancers has been completed.

• In a Phase II trial assessing bavituximab in combination with carboplatin/paclitaxel in NSCLC patients, overall response rate (ORR) was 43% (21 of 49 patients). Median PFS was 6.1 months. These results compare favorably with data from a published study showing an ORR of 19% and median PFS of 4.2 months in a similar patient population receiving carboplatin/paclitaxel alone.
• In a Phase II trial assessing bavituximab in combination with carboplatin/paclitaxel in advanced breast cancer patients, overall response rate (ORR) was 74% (34 of 46 patients). Median PFS was 6.9 months. These results compare favorably with data from a published study showing an ORR of 62% and median PFS of 4.8 months in a similar patient population receiving carboplatin/paclitaxel alone.
• In a Phase II trial assessing bavituximab in combination with docetaxel in advanced breast cancer patients, overall response rate (ORR) was 61% (28 of 46 patients). Median PFS was 7.4 months. These results compare favorably with data from a published study showing an ORR of 41% in a similar patient population receiving docetaxel administered as a single agent.