Peregrine Pharmaceuticals (NASDAQ:PPHM) Receives Fast Track Designation


Dallas, Texas 03/25/2014 (FINANCIALSTRENDS) –  Bavituximab, Peregrine Pharmaceuticals (NASDAQ:PPHM)’s lead clinical- immunotherapeutic candidate, has now received a Fast Track designation from the United States FDA to and will be launched in 2014. This is the latest- milestone in the product’s clinical-development as the potential treatment for 2nd-line non-small cell-lung cancer (NSCLC). Peregrine Pharmaceuticals (NASDAQ:PPHM)’s pipeline also includes its brain-cancer agent, named Cotara. This is a tumor- necrosis therapy that has demonstrated very promising results in the phase-II clinical trial in the patients suffering from glioblastoma multiforme, who have relapsed.

In 2013 December, Peregrine Pharmaceuticals (NASDAQ:PPHM) opened the enrollment for its pivotal phase-III SUNRISE trial that is examining bavituximab in the 2nd-line NSCLC setting. This trial is open to the patients suffering from stage IIIb/IV nonsquamous-NSCLC and who have now progressed after the standard frontline treatment. The patients will now be randomized to one of the two treatment-arms. All the patients will now receive upto 6 different 21-day-cycles of docetaxel (75 mg/ m2) and the weekly infusions of bavituximab (3 mg/ kg) or a placebo, until the progression/ toxicity. The primary-endpoint of this trial will be of overall survival. The trial will now enroll around 600 patients from over 100 medical-centers worldwide.

Bavituximab is the monoclonal antibody that effectively targets phosphatidylserine which is a phospholipid that is generally found on inner-leaflets of cell membranes. Phospholipid is very highly immunosuppressive, to such an extent when it is actually flipped and is then exposed on an outside of the tumor cells and the cells that line the tumor blood vessels, it actually evades the immune detection. Cancer therapies raise PS exposure on any cell surface, which further increases the immune suppression in thetumor-environment. Peregrine Pharmaceuticals (NASDAQ:PPHM)’s Bavituximab targets PS & blocks the immunosuppressive signal, & has also been shown to reactivate the immune system of the body .