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Leader in First-in-Class Monoclonal Antibodies Focused on the Treatment and Diagnosis of Cancer

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. We are pursuing multiple clinical programs in cancer with our lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( ), which provides development and biomanufacturing services for both Peregrine and outside customers.

For oncology indications , our lead PS-targeting candidate bavituximab in combination with chemotherapy has demonstrated promising signs of anti-tumor activitiy and survival trends in patients with non-small cell lung cancer (NSCLC) and advanced breast cancer.

Strong intellectual property is a valuable asset for Peregrine and we will continue to seek robust patent protection for key areas of our research and development efforts. Our extensive patent portfolio covers a number of technologies, including our drug product candidates and preclinical platforms.

While we are advancing the development of our later-stage product candidates in multiple ongoing clinical programs, we are seeking strategic alliances to broaden the geographic reach of our development programs or to advance our earlier-stage technologies and product candidates. For further information, please contact our Business Development department at: This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Bavituximab: A Novel Immunotherapy in Phase III Clinical Development in Second-Line Non-Small Cell Lung Cancer

In December, 2013, we announced the opening to enrollment of the SUNRISE (""Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study") trial of our lead clinical immunotherapeutic candidate bavituximab at leading oncology centers in the United States. SUNRISE is a pivotal Phase III clinical trial comparing the company's investigational immunotherapy bavituximab plus the chemotherapy docetaxel against placebo plus the chemotherapy docetaxel in patients with second-line non-small cell lung cancer (NSCLC). Patients with stage IIIb/IV non-squamous, NSCLC who have progressed after standard front-line treatment are eligible for enrollment. Patients will be randomized into 1 of 2 treatment arms. All patients will receive up to six 21-day cycles of docetaxel (75mg/m2) plus weekly infusions of either bavituximab (3mg/kg) or placebo, until progression or toxicity. The primary endpoint of the trial will be overall survival. This trial will enroll approximately 600 patients from more than 100 medical centers worldwide.

This follows reaching agreement with the U.S. Food and Drug Administration (FDA) in May 2013 on the design of the SUNRISE trial which was supported by promising data from a Phase IIb trial in patients treated with bavituximab plus docetaxel. These data showed an improvement in median overall survival (OS) of 11.7 months in the 3mg/kg bavituximab plus docetaxel arm compared to 7.3 months in the combined control arm (docetaxel plus 1mg/kg bavituximab or placebo) with a persistent separation in the Kaplan Meier survival curves (HR=0.662). In addition, overall survival subgroup analyses of key patient characteristics favored the bavituximab 3mg/kg arm, including age, gender, ECOG status, ethnicity and prior treatment. The results also indicated that the 3mg/kg bavituximab plus docetaxel combination was well-tolerated with no significant differences in adverse events between the trial arms.

For additional information about the SUNRISE trial please visit or using Identifier NCT01999673.

Bavituximab has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of second-line non-small cell lung cancer (NSCLC).

Bavituximab's broad therapeutic potential is also being explored through several cost-effective investigator sponsored trials (IST).

Cotara: A Novel Treatment for GBM Ready for Phase III Development

Cotara , our lead Tumor Necrosis Therapy (TNT) agent, demonstrated promising results in a Phase II clinical trial in glioblastoma multiform (GBM) patients at first relapse. Patient treatment in this trial was 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.

In December 2012, we announced that we had made significant progress in advancing the Cotara program into late-stage development through an agreement with the U.S. Food and Drug Administration (FDA) on the design of a single registration trial for Cotara in patients with recurrent glioblastoma multiforme (GBM).  The FDA agreed with our proposed randomized trial design comparing two dose levels of Cotara in up to 300 patients. The advancement of this program is dependent upon securing a licensing or funding partner to further advance Cotara into Phase III development.

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.