Guilford Pharmaceuticals Inc. said data from a secondPhase III study of its Gliadel wafers showed the drug,which delivers a chemotherapeutic agent directly to thesite of a brain cancer, improved survival of patients bymore than four months without the usual adversechemotherapy side effects.
Current treatments for brain cancer involve surgeryfollowed by radiation or intravenous chemotherapy andon average, patients live less than a year.
Craig Smith, president and CEO of Baltimore-basedGuilford, said his company expects to file a new drugapplication with the FDA for Gliadel by the end of 1995or in early 1996. If approved, it would be Guilford's firstmarketed product.
Guilford received approval last week from the FDA for atreatment investigational new drug application, enablingthe company to make Gliadel available to patients outsideclinical trials. As many as 20,000 brain tumor surgeries ayear are performed in the U.S.
"We see Gliadel as an adjunct to surgery, but we're nottrying to replace radiation," Smith said, adding the drugcan be used with both radiation and intravenouschemotherapy depending on physicians' preferences.
Gliadel is a small wafer made of a biodegradable polymerthat contains the FDA-approved drug, carmustine, ageneric chemotherapeutic drug. After removal of thebrain tumor, the wafers are implanted at the site of themalignancy, allowing the cancer-killing agent to actdirectly on remaining and recurring cancer cells.
The second Phase III trial, conducted in Europe, involved32 patients with malignant glioma, the most common andfatal form of brain cancer. The participants wereundergoing their first surgery to remove tumors and theyreceived either Gliadel or placebo wafers.
"The median survival was 58.3 weeks with Gliadel,"Smith said. "It was just under 40 weeks with theplacebo."
As in the first Phase III trial in the U.S., improvement inoverall survival was the primary endpoint and results inboth studies demonstrated Gliadel achieved statisticalsignificance.
Data from the European Phase III trial showed 63 percentof the Gliadel-treated patients were still alive after oneyear compared with 19 percent of those receivingplacebo. After two years, 31 percent of patients in theGliadel group were living and only 6 percent in theplacebo group.
In the U.S. Phase III study, patients were undergoing atleast their second surgery to remove recurring tumors.Overall survival of those receiving Gliadel increased 35percent. Median survival was extended eight weeks.
Among Gliadel's advantages, Smith said, are delivery ofthe chemotherapeutic drug without the debilitating sideeffects of intravenous chemotherapy.
Guilford's stock (NASDAQ:GLFD) Wednesday lost 37cents, closing at $16.12. n
-- Charles Craig
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