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What: Shares of Peregrine Pharmaceuticals (NASDAQ: PPHM ) , a developer of monoclonal antibodies targeted at cancer therapies, soared as much as 34% after the company agreed with the Food and Drug Administration on a late-stage trial design for Bavituximab.
So what: Peregrine announced today that it's come to an agreement with the FDA for its second-line non-small-cell lung cancer immunotherapeutic treatment, Bavituximab. The trial will include about 600 people worldwide and will compare Bavituximab with docetaxel versus just docetaxel alone, with overall survival being the primary endpoint. Peregrine expects to initiate this trial before the end of the year.
Now what: This might appear to be an exorbitant move for a small-cap biotech that's merely getting the thumbs-up from the FDA to run its late-stage trial. However, if you recall, Bavituximab's road to a phase 3 trial has been wrought with controversy. First, it supposedly more than doubled survival in mid-stage trials. Then, just a few weeks later, its CEO, Steven King (no, not that one!), delivered a nightmarish tale by informing investors not to trust these results. Finally, months later, it re-released the results, demonstrating a clinical benefit again. The simple fact that the FDA agreed to Peregrine's late-stage trial is in and of itself a big success. As for me, I'm still going to keep my distance, as small-cap cancer stocks have a terrible history of phase 3 success.
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