Shares in drug-maker Peregrine Pharmaceuticals took off on very heavy volume following news that the FDA was giving Fast Track designation to bavituximab, Peregrine’s lung-cancer treatment. Shares shot up over 22.5 percent on volume that exceeded 16.5 million shares by lunch. Average daily volume for the stock is only 1.2 million shares.
Bavituximab Fast-Tracked to Approval
The FDA’s Fast Track designation is applied to those drugs that treat serious or life-threatening illnesses and conditions and fill an unmet medical need, allowing drug companies addressing a need in the market to move products through the approval process faster.
The designation means an increase in the frequency of meetings and written correspondences with the FDA regarding the design of any clinical studies. It also allows for “rolling review,” which the FDA’s website describes as letting companies “submit completed sections of its Biological License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.”
While final approval is not guaranteed, the Fast Track designation would appear to improve its likelihood and reduce the amount of time before Peregrine would be able to begin marketing and selling the treatment. The company recently initiated a Phase-III clinical trial comparing bavituximab plus the chemotherapy docetaxel against placebo plus docetaxel in treating second-line non-small cell lung cancer (NSCLC), calling it SUNRISE.
"The fast track designation is a milestone for the SUNRISE trial program and represents a step closer to bringing bavituximab to the market," said Peregrine’s head of regulatory affairs, Robert Garnick, Ph.D. "We are very pleased that the FDA has recognized the potential of this novel therapy as a treatment for this serious and devastating type of cancer and look forward to working closely with them to ensure the most efficient review process."
PPHM May Have Novel Treatment for Lung Cancer in Bavituximab
Peregrine’s bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody. All cells have PS, a powerful immunosuppressive molecule, on the inside of cell membranes. However, this flips in cancerous cells, with the PS appearing on the outside of cells to allow tumors to evade detection. According to Peregrine’s website, “Bavituximab targets PS and blocks this immunosuppressive signal, and has been shown to reactivate the body’s immune system, restoring its ability to recognize and respond to tumors.”
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