Shares of Peregrine Pharmaceuticals, Inc. (PPHM) were up 14.5% after the company announced that its oncology candidate, bavituximab, has received Fast Track designation from the U.S. Food and Drug Administration (FDA). The Fast Track status was granted to bavituximab for second-line non-small cell lung cancer (NSCLC).
The news comes on the heels of the announcement last month of the initiation of a pivotal phase III study, SUNRISE, on bavituximab for 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 and placebo.
The SUNRISE study was designed on the basis of encouraging data from a phase II study. In the phase II study, bavituximab improved overall survival in patients suffering from second-line NSCLC.
Apart from NSCLC, bavituximab is being developed for multiple oncology indications including HER2-negative metastatic breast cancer (phase I – final data expected in 2014), advanced hepatocellular carcinoma (phase I/II – interim data to be presented in the first quarter of 2014), treatment naïve stage IV NSCLC (phase Ib) and stage II/III rectal adenocarcinoma (phase I). Peregrine Pharma also plans to initiate a phase Ib study evaluating bavituximab for advanced melanoma shortly.
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 carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Lannett Company, Inc. (LCI) and Forest Laboratories Inc. (FRX). Both carry a Zacks Rank #1 (Strong Buy).
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