The blinded study evaluated two dose levels of bavituximab given with docetaxel versus docetaxel plus placebo (control arm). Today’s rep[ort on the interim data showed a statistically significant improvement in overall survival and a doubling of median overall survival in the bavituximab-containing arms compared to the control arm.
Joseph Shan, vice president of clinical and regulatory affairs at Peregrine said, “The quality of this data gives us a solid foundation for designing a phase III trial with an increased probability of success. We are planning for an end-of-phase II meeting with the FDA as we plan to initiate this trial by mid-2013.”
Peregrine shares are now up a monster 49% at $4.59 on more than 7 million shares as of 1:22 PM EST and the market capitalization rate here is a mere $355 million.
JON C. OGG