Peregrine Pharmaceuticals, Inc. (PPHM) recently announced updated data on bavituximab from its randomized, double-blind placebo-controlled phase II trial that was conducted in patients with second-line non-small cell lung cancer (:NSCLC).
We note that last year, the company had presented results on bavituximab from the phase II study for second-line non-small cell lung cancer. However, later on, Peregrine Pharma had said that the data could not be relied on due to certain discrepancies between some patient sample test results and patient treatment code assignments.
Earlier this year, Peregrine Pharma provided an update on the situation and gave information from an internal review of the discrepancies.
The company said that discrepancies were isolated to the placebo and 1 mg/kg treatment arms of the trial with no evidence of discrepancies in the 3 mg/kg treatment arm of the trial.
The recently presented data from the phase II study were updated based on the completion of the earlier review of discrepancies in the study and the latest survival data from the study.
Updated results suggest a meaningful improvement in median overall survival in the 3mg/kg bavituximab + docetaxel arm compared to the control arm (11.7 months versus 7.3 months). Response rates and progression free survival were also favorable for the 3mg/kg bavituximab + docetaxel arm. Bavituximab was found to be well-tolerated with no significant differences in adverse events between the arms.
Peregrine Pharma intends to present these data as well as updated subgroup analysis and safety data at an upcoming scientific meeting.
Peregrine Pharma also intends to enter into discussions with regulatory bodies including an end-of-phase II meeting with the FDA by mid-2013. The company is looking to move the candidate into a pivotal study by year-end.
Bavituximab is a key pipeline candidate at Peregrine Pharma. Bavituximab is being studied for several indications including non-small cell lung cancer in the front and second-line settings, breast, prostate, liver and rectal cancers in combination with approved chemotherapies and radiation.
Peregrine Pharma currently carries a Zacks Rank #3 (Hold). We expect investor focus to remain on updates on the future development path for bavituximab. Biopharma companies that currently look more attractive include Cytokinetics, Inc. (CYTK) and Alexion Pharmaceuticals, Inc. (ALXN). While Cytokinetics is a Zacks Rank #1 (Strong Buy) stock, Alexion is a Zacks Rank #2 (Buy) stock. Another company that currently looks well-positioned is Actelion (ALIOF). Actelion is also a Zacks Rank #1 stock.
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