The FDA has approved Guilford Pharmaceuticals Inc.'streatment investigational new drug application, makingavailable to brain cancer patients the company's Gliadelwafer, a first-of-its-kind method of delivering achemotherapeutic drug directly to the tumor site.

Gliadel is a small wafer made of a biodegradable polymerthat contains the FDA approved drug, carmustine, whichis made by Bristol-Myers Squibb, of New York.

After a surgeon removes a brain tumor, up to eightGliadel wafers are implanted at the site of themalignancy, allowing the cancer-killing agent to actdirectly on remaining tumor cells. The chemotherapeuticdrug is released gradually as the wafers dissolve.

Approval of the treatment IND allows neurosurgeonsthroughout the U.S. to use the Gliadel wafers.

Guilford's president and CEO, Craig Smith, said theBaltimore, Md. company anticipates distributing amaximum of 500 Gliadel treatments during the FDA'sreview of the market application. Those wafers, Smithadded, will be provided free of charge.

In April 1995, Guilford released data from its first PhaseIII trials showing Gliadel increased overall survival ofbrain cancer patients, including those with the mostsevere form of the disease, by 35 percent compared with aplacebo.

Median survival of the Gliadel patients increased by eightweeks and they did not experience the adverse sideeffects associated with systemic radiation andchemotherapy.

Guilford will release data Tuesday from a second PhaseIII clinical study in Europe. Smith hinted at the results,saying Guilford intends to include the data in its new drugapplication (NDA) for the FDA. He said the NDA isexpected to be filed by the end of this year or early in1996.

Guilford said as many as 20,000 surgeries a year areperformed to remove malignant brain tumors.

Guilford's stock (NASDAQ:GLFD) closed Friday at $15,down 25 cents. n

-- Charles Craig

(c) 1997 American Health Consultants. All rights reserved.