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.
"I have them profitable in 1998," Mr. Berger said, based on projected Gliadel sales of $50 million to $75 million by 1998.
Shares in Guilford, which announced the results of the study yesterday, rose 37.5 cents, to $6.
There are as many as 20,000 brain cancer surgeries performed )) annually in the United States, Guilford President Craig Smith said. He said Gliadel could become the treatment of choice for 40 percent or more of brain cancer patients within three years after FDA marketing approval, depending on Guilford's success in reaching a marketing partnership with a larger company to sell the product.
"We would love to make a profit by 1998," Dr. Smith said. "That's not an unrealistic target if things go according to plan." But he warned that manufacturing problems, unforeseen problems getting FDA marketing approval or finding a marketing partner could delay the company's growth.
Dr. Smith said Guilford plans to manufacture Gliadel at a small factory in Baltimore that it recently completed. The 52-employee company expects to grow to between 100 and 150 employees if the FDA approves Gliadel, he said.