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Cancer vaccine testing gets green light
By: BRADLEY J. FIKES - Staff Writer | ∞
CARLSBAD ---- CancerVax Corp. said Monday it got approval to continue testing a cancer vaccine for patients with advanced melanoma, a deadly form of skin cancer.
The Carlsbad-based biotech company is in a Phase III trial of the cancer vaccine, named Canvaxin. Phase III testing determines a drug's safety and effectiveness. If successful, the trial is usually followed by an application to the U.S. Food and Drug Administration to begin selling the drug.
Shares of CancerVax closed Monday at $11.98 per share, down 27 cents for the day.
The approval came from the Data and Safety Monitoring Board, an independent panel of medical experts that is overseeing the trial.
The board could also have recommended changing the trial or ending it early due to obvious success. In this case, the board decided that no change was needed, and that running the trial to completion is reasonably likely to determine if Canvaxin is effective. Moreover, the board determined there was no unexpected or serious bad effects from Canvaxin that justified stopping the trial.
CancerVax has enrolled 842 out of a planned 1,118 patients in the trial, and estimates patient enrollment will be completed this year.
Canvaxin is a new kind of vaccine designed to stimulate the body's disease-fighting immune system. It's made from whole cancer cells, irradiated so they can't reproduce. The cells make about 40 antigens, which are proteins that provoke an immune response. These antigens appear to be associated with certain types of cancer cells.
The vaccine is injected into the patient. Since these cells are not the patient's, they are attacked by the immune system as foreign invaders. The expectation is that the immune system will associate the antigens with invading cells, so it will then attack the patient's own cancer cells.
Contact staff writer Bradley J. Fikes at bfikes@nctimes.com or (760) 739-6641.
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