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Biotech / Medical : Guilford (GLFD) - Steadily Rising -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (404)	12/6/2001 8:44:15 PM
From: Extra Pale	Respond to of 496

This seems like important news for glfd, given its relatively small market cap. Anyone follow this stock and care to comment? FDA Advisory Committee Believes GLIADEL(R) Wafer Provides Clinical Benefit With Acceptable Safety in Patients with Newly Diagnosed Malignant Glioma BALTIMORE, Dec 6, 2001 /PRNewswire via COMTEX/ -- Guilford Pharmaceuticals Inc., (Nasdaq: GLFD chart, msgs) announced today that the Oncologic Drugs Advisory Committee (ODAC) voted 8 to 5 that GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant) provides clinical benefit with an acceptable safety profile for the treatment of patients with newly diagnosed malignant glioma. Some committee members, however, expressed concerns about the size of the study, the analytical methods and the pathological diagnosis. While the FDA is not bound by the recommendation, it traditionally follows the Committee's advice. (Photo:http://www.newscom.com/cgi-bin/prnh/20011206/PHTH046 ) "The positive outcome of the FDA Advisory Committee meeting is an important step forward in our efforts to bring the benefits of GLIADEL(R) Wafer to more patients," said Craig R. Smith, M.D., President and Chief Executive Officer of Guilford. "We will continue to work closely with the FDA to help them expeditiously complete their action on our sNDA." Clinical Trial Design The Committee based their recommendation to approve an expanded label for GLIADEL(R) Wafer on a randomized, double-blind, placebo-controlled Phase III clinical trial, which was conducted in 240 eligible men and women at 38 study centers in 14 countries. Beginning in December 1997, patients were enrolled and randomly assigned to receive either GLIADEL(R) Wafer or placebo wafers, in addition to receiving standard therapy for malignant glioma, which included surgery and radiation. The primary endpoint in the study was overall survival at 12 months. Depending on the date of enrollment in the study, patients were followed for a minimum of 12 months and a maximum of 30 months. Secondary endpoints included measures of neurological outcome and disease progression. Clinical Trial Results The Phase III study results demonstrated about a 30 percent improvement in survival rates and neurological symptoms in patients who received GLIADEL(R) Wafer therapy. At one year, 59 percent of patients given GLIADEL(R) Wafer were still alive compared to 48 percent of those given placebo. A secondary endpoint in the study -- improvement in neurological symptoms -- also demonstrated a significant benefit in the GLIADEL(R) Wafer treatment group. "Implanted at the time of initial surgery, GLIADEL(R) Wafer offers patients the benefits of localized chemotherapy without the devastating side effects of systemic treatments, while offering the hope of extended survival and delayed onset of neurological deterioration," said Alan Hamilton, MD, Chief, Division of Neurosurgery, University of Arizona Health Sciences Center.