First-in-Class PS-Targeting Monoclonal Antibody

Currently in Phase II clinical development, bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that has demonstrated broad therapeutic potential across multiple oncology indications and represents a new approach to treating cancer. Bavituximab is currently being evaluated in three randomized Phase II clinical trials for non-small cell lung cancer (NSCLC) and pancreatic cancer.

Randomized Phase II Bavituximab Clinical Trials

• Second-line NSCLC: This randomized, double-blinded, placebo-controlled Phase II trial is evaluating bavituximab with docetaxel versus docetaxel with placebo in up to 120 second-line NSCLC patients. Patient enrollment in this trial has been completed with data from the study expected to be unblinded in the first half of 2012.
• Front-line NSCLC: This randomized, open-label Phase II trial is evaluating bavituximab with paclitaxel and carboplatin versus paclitaxel and carboplatin in 86 front-line NSCLC patients. Patient enrollment in this trial has been completed with promising preliminary data from the study reported in the fourth quarter of 2011.
• Pancreatic Cancer: Patient enrollment is open in a randomized, open-label Phase II trial evaluating bavituximab with gemcitabine versus gemcitabine in up to 70 patients with previously untreated stage IV pancreatic cancer. Click here to learn more about this trial and other Peregrine clinical trials currently enrolling patients.

Investigator-Sponsored Trials

In addition to our company-sponsored trials, the broad therapeutic potential of bavituximab is being evaluated in four investigator sponsored trials in multiple indications. Read more...

Clinical Data

Conference Presentations and Data Releases

Lung Cancer

• In December 2011 we announced preliminary results from our randomized Phase II front-line NSCLC trial showing a 50% improvement in overall tumor response rate (ORR) in patients treated with bavituximab plus carboplatin and paclitaxel versus patients treated with carboplatin and paclitaxel alone. This preliminary analysis using RECIST guidelines included all 86 front-line, Stage IV NSCLC patients randomized in the trial. We plan to report on secondary endpoints, including median progression-free survival (PFS) and median overall survival (OS) once reached during 2012.

• In June 2011, we reported promising 12.4 month median overall survival (OS) from a single-arm Phase II front-line NSCLC trial. Read more...

• • Median OS of 12.4 months using bavituximab in combination with carboplatin and paclitaxel compared to 10.3 month MOS from a separate historical control trial using carboplatin and paclitaxel alone in a similar patient population.
  • Median OS is consistent with encouraging earlier data reported at ASCO 2010, including objective response rate (ORR) of 43% and median progression-free survival (PFS) of 6.1 months, versus historical control data of 15% ORR and 4.5 months PFS.

Breast Cancer

• In a Phase II front-line trial, ORR was 74% (n=46), median PFS was 6.9 months, and median OS was 23.2 months for patients treated with bavituximab in combination with carboplatin and paclitaxel. These results exceed the 62% ORR, 4.8 month median PFS, and 16 month median OS of carboplatin and paclitaxel alone from a separate historical trial.
  Read more... (300k PDF)
• In a Phase II second-line trial of patients treated with bavituximab in combination with docetaxel, ORR was 61% (n=46). This exceeds 41% ORR of docetaxel alone from a separate historical trial. Median overall survival from the study was 20.7 months which exceeds 11.4 months median overall survival from patients receiving docetaxel alone in a separate historical trial.
  Read more... (300k PDF)