Guilford seeks FDA OK of anti-cancer implant


February 08, 1996

Guilford Pharmaceuticals Inc., a Baltimore-based biotechnology company, said yesterday that it has filed an application for regulatory approval from the U.S. Food and Drug Administration to market its wafer implant that prevents brain cancer relapses.

The company hopes to have a hearing on the application later this year.

JTC Guilford Pharmaceuticals already has FDA approval to distribute the wafer, called Gliadel, to neurosurgeons who have patients with a recurrence of malignant brain cancer. The company says the implant was developed to prevent relapses and reduce the side effects of chemotherapy by applying drugs directly to cancer cells.

As part of its application to the FDA yesterday, Guilford submitted two clinical studies that showed that Gliadel improved patient survival rates after tumor removals.

One clinical trial involving 222 people showed that 60 percent of patients given Gliadel, a biodegradable implant that releases a chemotherapeutic drug into the tumor, survived for at least six months, and 47 percent of those given a placebo survived at least six months.

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