Guilford Pharmaceuticals Inc. of Baltimore said yesterday that a successful clinical trial of its brain cancer implant in Europe paves the way for the company to ask federal regulators for permission to use the product to treat more of the 20,000 patients who have brain cancer surgery annually in the United States.
The results, if they lead to a broader U.S. regulatory approval of the company's chemotherapy substitute, would expand the commercial potential of a product that analysts predict will make the 2-year-old biotech firm profitable by 1997 or 1998.
"We don't know how the [U.S. Food and Drug Administration] will react to the European trial," said Andrew R. Jordan, Guilford's chief financial officer.
The product, called Gliadel, is a wafer saturated with chemotherapy drugs that surgeons implant after removing a brain tumor to kill stray remaining cancer cells and delay or prevent a relapse.
The FDA recently allowed the company to put the product on the market under limits on pricing and marketing. The company plans to apply next year for permission to market Gliadel without those limits.
But the European clinical trial was aimed at a much different group of patients than were the previous U.S. studies.
The trial allowed Guilford to seek a broader U.S. approval than it could have supported based on U.S. research.
In the European trial, surgeons gave Gliadel to 16 patients who were undergoing surgery to remove brain tumors for the first time and gave 16 other patients placebos that resembled Gliadel. Patients in the U.S. trials were not given Gliadel until they were having their second brain surgeries, after conventional chemotherapy and/or radiation treatments had failed to prevent a relapse.
Mr. Jordan said the company needed to conduct the latest trial outside the United States, because most American doctors would not agree to give placebos to brain cancer patients undergoing their first surgeries.
European doctors were more receptive, because many physicians in Finland and Sweden, where the trial was held, do not routinely give chemotherapy. They believe that chemotherapy is ineffective against brain cancer after the first operation.
"In the U.S., it would be highly unlikely you could do this trial on first surgery," Mr. Jordan said.
He said 63 percent of the patients who were given Gliadel in the European trial survived a year after their first surgery, compared with 19 percent of those who were given a placebo. The Gliadel patients' median survival after surgery was 58 weeks, almost 50 percent better than the 40-week median survival of placebo patients.
"This is not a cure for brain cancer," Mr. Jordan said. "It is what we hope will be a first therapy that will prolong life, with an increase in the quality of life."
Because Gliadel allows surgeons to put chemotherapy drugs so pTC close to the cancerous cells that are left behind during surgery, the drugs do not have to travel through the bloodstream to reach the brain. That should allow Gliadel patients to have fewer side effects than those who undergo conventional chemotherapy, the company said.
Conventional intravenous chemotherapy adds only four weeks to the average life span of a brain cancer patient, Mr. Jordan said.