A new study in a prestigious British medical journal strongly endorses a brain cancer treatment developed by Guilford Pharmaceuticals Corp., whose executives plan to submit the product to the U.S. Food and Drug Administration for marketing approval late this year.
An analyst who follows Guilford said speedy FDA approval of the company's Gliadel product could make Guilford profitable as soon as 1998. Gliadel is a slow-dissolving polymer wafer saturated with chemotherapy drugs that surgeons implant in the hole left in the brain by the removal of cancerous tumors.
Gliadel uses the same chemotherapy drug doctors now use, but places the drug directly upon any cancerous cells left behind after surgery. That eliminates need to circulate the drug, a distant chemical cousin to mustard gas, to other parts of the body, where it can cause severe side effects.
"It changes the way chemotherapy can be administered," said ** Henry Brem, a Johns Hopkins Medical Institutions neurosurgeon who led 10 years of Gliadel research and is lead author of the paper in today's issue of the Lancet. "It can be delivered directly to a tumor, which is the most effective way to give chemotherapy, and it spares the rest of the body the side effects of chemotherapy."
The researchers report that advanced brain cancer patients given Gliadel lived an average of 31 weeks, compared to 23 weeks for a control group of patients who were given placebos. The study, representing the results of the drug's Phase III clinical trial, was done on 222 patients, all of whom had suffered relapses after previous surgeries to remove brain cancers.
Dr. Brem said direct delivery of chemotherapy could also pave the way for much stronger anti-cancer drugs, including taxol, to be given to brain cancer patients.
These stronger drugs have increased long-term brain cancer survival rates from virtually zero to better than 20 percent in animal studies. But they aren't used on human brain tumors because without a direct delivery system like Gliadel, they either damage healthy cells outside the brain or cannot penetrate blood vessels in the brain to reach the tumor.
Gliadel is one of many products that Baltimore-based Guilford is developing, but is several years ahead of any of the company's other drugs in clinical trials required for FDA approval. Josephthal, Lyon & Ross Inc. analyst Franklin M. Berger said Gliadel could be enough to make the year-old biotechnology company profitable for the first time.
