(By Balaseshan) Peregrine Pharmaceuticals (NASDAQ:PPHM) shares touched a new 5-year high after biopharmaceutical company presented interim results from its non-small cell lung cancer trial.
The 121 patient randomized, double-blind, placebo-controlled Phase 2b study evaluated two dose levels of bavituximab (bavituximab-containing arms) given with docetaxel versus docetaxel plus placebo (control arm).
The interim data showed a statistically significant improvement in overall survival and a doubling of median overall survival (OS) in the bavituximab-containing arms compared to the control arm.
Peregrine is planning for an end-of-phase 2 meeting with the FDA as the company plans to initiate this trial by mid-2013. The company said the latest clinical data strongly support advancing program into phase 3 clinical development.
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The interim results from the study showed no significant safety differences between the three treatment arms as determined by the trial's independent data monitoring committee. Baseline characteristics were well balanced across all three treatment arms of the study, including performance (ECOG) status, age, gender, and race.
"Our attention is now turned to an end of phase 2 meeting by year end which will help us define the most efficient path forward to potential regulatory approval. A global Phase 3 trial designed very similarly to the robust design of this Phase 2 greatly increases bavituximab's likelihood of success," said Robert Garnick, head of regulatory affairs at Peregrine.
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The interim data was presented as part of a late-breaking plenary presentation at the 2012 Chicago Multidisciplinary Symposium in Thoracic Oncology by David Gerber, Associate Professor of Internal Medicine at the University of Texas Southwestern Medical Center, a principal investigator in the trial.
PPHM is trading 44.63% higher at $4.44 on Friday. The stock has been trading between $0.39 and $5.08 for the past 52 weeks.