Peregrine Pharmaceuticals 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 - Free Report) 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 and Gilead Sciences, Inc. (GILD - Free Report) currently look more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).