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Leader in First-in-Class Monoclonal Antibodies for Cancer and Viral Infections

Peregrine Pharmaceuticals (Nasdaq: PPHM) is a clinical-stage biopharmaceutical company developing and manufacturing innovative monoclonal antibody therapeutics for the treatment of cancer and viral infections. Our clinical pipeline includes bavituximab, a first-in-class monoclonal antibody with demonstrated broad-spectrum potential in cancer and viral diseases, and Cotara®, our novel brain cancer therapy. Both bavituximab and Cotara are currently in Phase II clinical development.

For oncology indications, our lead PS-targeting candidate bavituximab in combination with chemotherapy has demonstrated in prior Phase II trials consistent, promising signs of anti-tumor activity in patients with non-small cell lung cancer (NSCLC) and advanced breast cancer. Based on these encouraging results, we are conducting several randomized Phase II trials in different oncology indications:

  • Second-line NSCLC trial evaluating bavituximab combined with docetaxel in up to 120 patients. Patient enrollment in this trial was completed in October 2011 and we expect to unblind data in the first half of 2012
  • Front-line NSCLC trial evaluating bavituximab plus paclitaxel and carboplatin in 86 NSCLC patients. Patient enrollment in this trial was completed in September 2011. In December 2011 we announced preliminary results from this 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 overall survival (OS) once reached during 2012.
  • Front-line pancreatic cancer evaluating bavituximab with gemcitabine in up to 70 patients with previously untreated stage IV pancreatic cancer

In addition to the trials we are conducting, bavituximab's broad-spectrum therapeutic potential is being explored through several cost-effective investigator-sponsored trials (IST).

For viral infection indications, we are evaluating bavituximab combined with ribavirin in a randomized Phase II trial in 66 treatment naive patients with genotype-1 hepatitis C virus (HCV) infection. Patient enrollment in this trial was completed in September 2011 with preliminary results from the study reported in December 2011.

Cotara, our lead Tumor Necrosis Therapy (TNT) agent, is currently being evaluated in a Phase II clinical trial in glioblastoma multiform (GBM) patients at first relapse. Patient treatment in this trial has been completed and top-line data was presented in a poster session at the ASCO 2011 annual meeting. A novel approach to treating brain cancer, Cotara targets necrotic cells at the core of solid tumors. It transports and binds radioactive iodine to the center of the tumor, allowing the radiation to destroy the tumor from the inside out.

Unique for a biopharmaceutical company, we have an integrated asset Avid Bioservices, which provides biomanufacturing services for its clients as well as products for our clinical trials.