Peregrine Pharmaceuticals (PPHM) recently presented encouraging data related to immune-stimulatory mechanism of action of phosphatidylserine (:PS)-targeting antibodies from preclinical studies and other ongoing studies. We note that the company’s lead candidate, bavituximab, a PS-targeting monoclonal antibody, is being developed for multiple oncology indications.
Peregrine Pharma expects to initiate a phase III study on the candidate for the treatment of second-line non-small cell lung cancer (:NSCLC) by the end of 2013. In May 2013, the U.S. Food and Drug Administration agreed on the design of the phase III registration trial on bavituximab for the treatment of second-line NSCLC.
The randomized, double-blind, placebo-controlled, phase III trial (n=600) will be conducted across the world among stage IIIB/IV non-squamous NSCLC patients, whose disease progressed after standard front-line treatment, with the primary endpoint being overall survival. The study will compare bavituximab in combination with Sanofi’s (SNY) Taxotere (docetaxel) to Taxotere alone.
We note that bavituximab is a key pipeline candidate at Peregrine Pharma. In addition to second-line NSCLC, bavituximab is being studied for other indications including front-line pancreatic cancer, breast, liver and rectal cancer.
We expect investor focus to remain on updates pertaining to bavituximab. The successful development and commercialization of bavituximab would be a major positive for Peregrine Pharma which currently has no approved drug.
Peregrine Pharma currently carries a Zacks Rank #3 (Hold). Stocks such as Actelion (ALIOF) and Gilead Sciences, Inc. (GILD) currently look more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).
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