Shares of Peregrine Pharmaceuticals soared this afternoon after the biotech boasted of some impressive results from its Phase IIb study of the closely watched lung cancer drug bavituximab. The California biotech says the treatment arm demonstrated an overall survival rate more than double the placebo group's.
Depending on the drug dosage, non-small cell lung cancer patients who took bavituximab lived between 11.1 and 13.1 months with a median average of 12.1 months, according to Peregrine ($PPHM). Those on chemo alone had a survival rate of about 5-and-a-half months. The median progression-free survival (PFS) rate in the bavituximab arm was 4.2 months, compared with 3 months in the placebo group. That caused some excitement on Twitter, as some analysts wondered how a limited PFS rate could translate into such a dramatic score for OS. 121 patients with refractory non-small cell lung cancer took part in the randomized, double-blind trial.
"The median overall survival results from the proof-of concept study are truly outstanding and great news for patients," said Robert Garnick, Peregrine's head of regulatory affairs, in a statement. "Statistically significant overall survival results at this stage of development are rare and have put us in an excellent position for advancing the program."
For Peregrine, which has seen its stock rise higher and higher recently, the data provide an edge in partnership talks as investigators design a pivotal Phase III trial. Peregrine hopes to initiate a Phase III trial by mid-2013. Planning for an end-of-Phase II meeting with the FDA is also in the works.
Researchers aren't the only ones happy with the development. Investors also cheered as Peregrine's stock skyrocketed 46% Friday afternoon. The company's stock took a hit in March after a previous study revealed progression-free survival with bavituximab wasn't much different from what a standard cancer treatment offered.
But not all analysts are convinced by the data. Small, public biotech companies have a terrible track record when it comes to cancer drug development. That prompted TheStreet's Adam Feuerstein to take a skeptical look at the data, wondering whether ex-U.S. data from trials in Russia, the Ukraine, Georgia and India may have skewed results in its favor. More Phase II data due out soon may answer those questions.