Peregrine Financial Results and Recent Developments: Three Phase II Programs Advancing in Liver Cancer and HCV

07/15/2011 | 06:20 am
Peregrine Pharmaceuticals Reports Fourth Quarter and Fiscal Year 2011 Financial Results and Recent Developments

Three Phase II Programs Advancing in Oncology and HCV Infection Indications
TUSTIN, CA -- (MARKET WIRE) -- 07/14/11 -- Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced financial results for the fourth quarter and fiscal year (FY) 2011 ended April 30, 2011 and provided an update on its advancing clinical pipeline and other corporate developments.

"During this fiscal year, we advanced our clinical pipeline significantly by reporting promising clinical data from five trials and launching four new randomized Phase II trials and four investigator-sponsored trials for our lead clinical product bavituximab, building for what we expect to be an exciting fiscal year 2012," said Steven W. King, president and chief executive officer of Peregrine. "Our primary focus for the second half of this year is to continue advancing our three Phase II clinical programs for bavituximab and Cotara® and to reach important and potentially value-building clinical and regulatory milestones. This effort will be led by our management team, which has been expanded with additional clinical, quality, and manufacturing experts with experience in developing and commercializing biological therapies similar to our bavituximab and Cotara programs."

Clinical Program Update

Bavituximab Clinical Trials

In four ongoing randomized Phase II trials, Peregrine is evaluating bavituximab's broad therapeutic potential in non-small cell lung cancer, pancreatic cancer, and hepatitis C virus (HCV) infections. Bavituximab is a first-in-class monoclonal antibody that targets the highly immunosuppressive molecule phosphatidylserine (PS), enabling the immune system to recognize and fight cancer and viral infections.

-- Phase II front-line NSCLC trial evaluating bavituximab with carboplatin

and paclitaxel versus carboplatin and paclitaxel. Enrollment of up to

86 patients is expected to be completed over the next few weeks with

interim data expected by the end of this year. Last month, Peregrine

reported promising 12.4 months median overall survival (OS) from a

prior single-arm Phase II trial using this same therapeutic regimen in

49 front-line NSCLC patients. The OS was consistent with encouraging

earlier data, including 43% objective response rate (ORR) and 6.1

months median progression-free survival (PFS). These data exceed the

10.3 month OS, 15% ORR, and 4.5 months PFS reported from a separate

historic control trial evaluating carboplatin and paclitaxel alone in a

similar patient population.

-- Phase II second-line non-small cell lung cancer (NSCLC) trial

evaluating bavituximab with docetaxel versus docetaxel plus placebo.

Peregrine has modified patient enrollment criteria and has 37 sites

open in the U.S. and internationally and expects to complete enrollment

of up to 120 patients early in the fourth quarter of this year. The

primary endpoint for this study is overall response rate and these data

are expected to be unblinded in the first half of 2012. Secondary

endpoints include median OS and median PFS.

-- Phase II pancreatic cancer trial evaluating bavituximab with

gemcitabine versus gemcitabine is currently enrolling up to 70 patients

with previously untreated stage IV pancreatic cancer.

-- Phase II trial in patients with previously untreated genotype-1

hepatitis C virus (HCV) infection, Peregrine is measuring the early

virologic response (EVR) rate after 12 weeks of therapy with

bavituximab in combination with ribavirin versus standard of care,

pegylated interferon alpha 2a and ribavirin.

To further evaluate bavituximab's broad potential in additional oncology indications and therapeutic combinations, Peregrine's investigator-sponsored trials (IST) program has four currently enrolling clinical trials.

-- Phase I/II trial evaluating bavituximab combined with sorafenib in

approximately 50 patients with advanced liver cancer. This IST is

being conducted at University of Texas Southwestern Medical Center.

-- Phase I/II trial evaluating bavituximab combined with cabazitaxel in 31

patients with second-line castration resistant prostate cancer (CRPC).

This IST is being conducted at the University of California, Irvine.

-- Phase Ib trial evaluating bavituximab combined with pemetrexed and

carboplatin in up to 25 front-line NSCLC patients. This IST is being

conducted at the University of North Carolina at Chapel Hill.

-- Phase I trial evaluating bavituximab combined with paclitaxel in

patients with HER2-negative metastatic breast cancer. This IST is

being conducted at the Arizona Cancer Center at UMC North.

Cotara® Phase II Brain Cancer Program

At the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June, Peregrine reported promising interim OS data of 8.8 months (38 weeks) from a Phase II trial treating 41 patients with recurrent glioblastoma multiforme (GBM) with a single infusion of Cotara. Cotara is a targeted monoclonal antibody linked to a radioisotope that is administered as a single-infusion treatment directly into the tumor, destroying the tumor from the inside out, with minimal exposure to healthy tissue. Peregrine plans to meet with the FDA in the fourth quarter of 2011 to determine the optimal registration pathway for Cotara.

For more information on Peregrine's clinical trials, please visit http://www.peregrinetrials.com/ .