WASHINGTON (AP) — Shares of Peregrine Pharmaceuticals Inc. surged Monday after the company said it would move ahead with a late-stage trial of its lead product, the experimental lung cancer treatment bavituximab.
THE SPARK: Peregrine said in a release it reached an agreement with the Food and Drug Administration on a phase III study of its drug involving 600 patients. The trial will enroll patients with non-small cell lung cancer whose disease has progressed after treatment with standard therapy. The study will evaluate bavituximab based on patients’ overall survival.
The Tustin, Calif.-based drugmaker said it would present final data from its mid-stage studies of the drug at a meeting for cancer specialists on June 1.
THE BIG PICTURE: Peregrine does not have any approved products and bavituximab is its most advanced experimental drug. In early September Peregrine said patients who were treated with bavituximab lived twice as long as patients who received only chemotherapy in a clinical trial.
A few weeks later the company said it had found problems with the reported trial data and its initial analysis couldn’t be relied on. Peregrine said the problem appeared to be tied to another company that was contracted to code and distribute the product. In January Peregrine reported that the discrepancies are limited to a single dose of the drug.
SHARE ACTION: Peregrine shares rose 34 cents, or 22 percent, to $1.88 in trading Monday.
