Header graphic for print
Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

New Cancer Drug (Bavituximab – Peregrine Pharmaceuticals) Gains FDA Fast Track Designation

Posted in Drug Studies, Public Health

In recent pharmaceutical news, a new cancer drug from Peregrine Pharmaceuticals, Inc. called Bavituximab has earned Fast Track designation by the US Food and Drug Administration, The Wall Street Journal reports.

“The FDA Fast Track Development Program is a designation of the United States Food and Drug Administration (FDA) that accelerates the approval of investigational new drugs undergoing clinical trials with the goal review time of 60 days. Such status is often given to agents that show promise in treating serious, life-threatening medical conditions for which no other drug either exists or works as well.” (Wikipedia)

Bavituximab is used in the treatment of “second-line non-small cell lung cancer (NSCLC)” and “represents a new approach to treating cancer.” (WSJ)

This drug works by targeting immunosuppressive molecules known as phosphatidylserine (PS).  While PS molecules are found inside healthy cells, in cancer cells they lie on the outer membrane “of cells that line tumor blood vessels”, and make for a relatively straightforward target for cancer drugs.  Bavituximab seeks out PS molecules and binds with them, thus suppressing their immunosuppressant quality, if you will, and allowing the immune system to attack the cancerous cells. (WSJ)

The research explaining the mechanism by which Bavituximab targets PS molecules appears in an October 2013 edition of Cancer Immunology Research, the peer-reviewed publication of the American Association for Cancer Research.

“Bavituximab is currently being evaluated in several solid tumor indications, including non-small cell lung cancer, breast cancer, liver cancer and rectal cancer with a trial in advanced melanoma anticipated to initiate in the near future.” (WSJ)