Guilford Pharmaceuticals Inc. Wednesday submitted a new drugapplication (NDA) to the FDA for approval of Gliadel, a first-of-its-kind method of delivering a chemotherapeutic agent directly to thesite of a malignant brain tumor.
Baltimore-based Guilford supported the NDA with two Phase IIIstudies of Gliadel showing statistically significant improvement insurvival of brain cancer patients without the adverse side effectscaused by systemic chemotherapy treatments.
Gliadel is a small wafer made of a biodegradable polymer thatcontains carmustine. The drug, which would be Guilford's firstmarketed product, is used in association with surgery, but is notdesigned as a replacement for subsequent radiation treatments.
Following removal of a brain tumor, up to eight Gliadel wafers areimplanted at the site of the malignancy where they slowly dissolve,releasing the chemotherapeutic drug to kill remaining and recurringcancer cells.
Because the carmustine is delivered directly to tumors, the dose isless than that needed for intravenous administration, minimizing sideeffects.
Current treatments for brain cancer involve surgery followed byradiation or intravenous chemotherapy and on average patients liveless than a year.
In October 1995, Guilford received FDA approval for a treatmentinvestigational new drug application (IND), which allowed thecompany to make Gliadel broadly available for recurrent malignantglioma, the most common and fatal form of brain cancer.
More than 20,000 brain tumor surgeries are performed each year inthe U.S.
Nick Landekic, Guilford's vice president of business development,said that since getting clearance for the treatment IND, the companyhas received requests for Gliadel from 100 medical institutionsthroughout the U.S.
Results from Guilford's first 222-patient Phase III study in NorthAmerica showed Gliadel improved median survival by two months.After six months, 60 percent of the Gliadel patients were alivecompared with 47 percent of those who received a placebo.
Patients enrolled in the U.S. trials were undergoing a repeat surgery.In the second 32-patient Phase III study in Europe, Gliadel was usedduring the first operation to remove a brain tumor.
Guilford officials said results of the European trials were better thanfindings in the North American studies. Sixty-three percent of theGliadel treated patients were alive after one year compared with 19percent of those receiving a placebo. At the end of two years, 31percent of the patients in the Gliadel group were living comparedwith 6 percent in the placebo group. Median survival with Gliadelwas more than four months greater than with the placebo.
Guilford's stock (NASDAQ:GLFD) closed Wednesday at $22.50, up37 cents. n
-- Charles Craig
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