Peregrine has most of the P2 cancer data now, and has shared it with FDA. It must be very strong data. The company and FDA seem to have agreed on a P2 trial that will, if consistent with previous results, lead to accelerated bavituximab approval for second-line NSC Lung Cancer. The company (Avid) has already stockpiled large quantities of bavi.
We heard it from Steve King today. Here is Joe Shan from the recent Q3 CC:
“The first new trial will treat lung cancer patients who have progressed after standard first-line treatment. This will be one of the largest and most important trials for Peregrine to-date and has required extensive planning, manufacturing and regulatory preparations in anticipation of this critical milestone. This Phase II trial will be a randomized, double-blinded study comparing docetaxel plus bavituximab versus docetaxel plus a placebo. This is a very rigorous study designed with many features typically reserved for Phase III trials and results will be reported when the data are unblinded at the end of the study.
As you may recall, following our successful meeting with the FDA last November, we decided to pursue this segment of refractory lung cancer patients, who have an unmet medical need and believe this indication could provide an expedited path to regulatory approval. While the trial design I described could position us to take advantage of very strong clinical trial data and results and seek accelerated approval, we expect this trial will be part of a registrational package that will include Phase III development.”
With this design the phase III portion can be conducted after bavituximab's commercial approval.
I believe bavi will be approved to treat cancer in calendar year 2011.
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