GLFD Guilford Pharmaceuticals (MM)

Guilford Pharmaceuticals Receives European Marketing Authorization for Expanded Use of GLIADEL(R) Wafer GLIADEL(R) Approved to Treat Newly-Diagnosed Patients with Malignant Glioma BALTIMORE, Sept. 14 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc. (NASDAQ:GLFD) today announced that its proprietary treatment for brain cancer, GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant), has been granted extended marketing authorization in Europe to include use in newly- diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation. Under the mutual recognition procedure, GLIADEL(R) has been approved for use in the following countries: France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain and the United Kingdom. GLIADEL(R) was previously authorized for use only in recurrent surgery for glioblastoma multiforme. GLIADEL(R) is a biodegradable wafer, implanted at the time of surgery, that delivers chemotherapy directly to the tumor site, minimizing drug exposure to other areas of the body. GLIADEL(R) complements other standard therapies for brain cancer, such as surgery, radiation and intravenous chemotherapy. The European approval was based on favorable data from a randomized, double-blind, placebo-controlled Phase III clinical trial that enrolled 240 adult men and women undergoing initial surgical resection of a high-grade malignant glioma in 38 centers in 14 countries. Complete follow-up for as long as 48 months was obtained for 239 of the 240 patients. Of the 11 patients known to be alive on the date of last follow up, 9 received GLIADEL(R) and 2 received placebo. Survival was prolonged in the GLIADEL(R) treatment group (median survival increased to 13.9 months from 11.6 months, p