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Guilford Pharmaceuticals Inc. (ticker: GLFD, exchange: NASDAQ) News Release - 6/6/2001 -------------------------------------------------------------------------------- Guilford`s Supplemental New Drug Application for GLIADEL(R) Wafer Accepted For Review by the FDA BALTIMORE, June 6 /PRNewswire/ -- Guilford Pharmaceuticals Inc. (Nasdaq: GLFD) announced today that its supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to seek approval to expand the labeled indication for GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant) to include first line therapy in patients newly diagnosed with malignant glioma has been accepted for review by the FDA. The sNDA for GLIADEL(R) Wafer contains all required elements and the agency has indicated it will be proceeding with a priority review. The first new therapy to be approved for the treatment of brain cancer in over two decades, GLIADEL(R) Wafer received marketing approval from the U.S. Food and Drug Administration in September 1996 to treat recurrent glioblastoma multiforme (GBM), a common form of malignant brain cancer. Presently, GLIADEL(R) Wafer is approved for use for recurrent surgery in 21 countries worldwide. GLIADEL(R) Wafer is a small, white dime-sized wafer made of a biodegradable polymer that contains the cancer chemotherapeutic drug, carmustine or BCNU. Up to eight GLIADEL(R) Wafers can be implanted in the cavity created when a brain tumor is surgically removed. There, the wafers slowly dissolve over a period of 2 to 3 weeks, delivering chemotherapy directly to the tumor site in high concentrations, while minimizing drug exposure to other areas of the body. "Each year in the United States there are approximately 8,000 - 12,000 surgeries performed to treat malignant brain cancer. Unfortunately, the recurrence rate for GBM is very high and approximately one third of these patients will experience a recurrence of their primary tumor and require a second surgery," commented Dr. Craig R. Smith, President and Chief Executive Officer. "Presently, GLIADEL(R) Wafer is approved to treat only the 30% of patients who experience tumor recurrence. However, should GLIADEL(R) Wafer receive approval from the FDA for use at the time of initial diagnosis and surgery, we`re hopeful that we can bring the treatment benefits of localized chemotherapy with GLIADEL(R) Wafer to more patients worldwide." GLIADEL(R) Wafers have generally been well tolerated. However, GLIADEL(R) Wafer contains carmustine and should not be given to patients who are allergic to carmustine. Carmustine can also cause fetal harm when administered to a pregnant woman. Patients undergoing surgery for malignant brain cancer and implantation of GLIADEL(R) Wafer should be monitored closely for the following known complications of surgery including: seizures, intracranial infections, abnormal wound healing, and brain edema. Each of these complications has been associated with GLIADEL(R) Wafer treatment. Guilford Pharmaceuticals Inc. is a biopharmaceutical company engaged in the development of biopolymer-based therapeutics for cancer and other diseases, and novel products for the diagnosis and treatment of neurological disorders. For more information about GLIADEL(R) Wafer, visit www.gliadel.com. Contact: Guilford Pharmaceuticals Stacey Jurchison 410-631-5022 or (cell) 410-274-5266 Angie Rubin 410-631-6449 Internet addresses: www.guilfordpharm.com This press release contains forward-looking statements that involve risks and uncertainties, including those described in the section entitled "Risk Factors" contained in the Company`s Annual Report on Form 10-K for the year ended December 31, 2000, that could cause the Company`s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. Among other things, there can be no assurance that the results of the third multi-center Phase III clinical trial will support approval of GLIADEL(R) Wafer in the U.S., Europe and elsewhere for treatment of patients with malignant glioma at the time of first surgery. MAKE YOUR OPINION COUNT - Click Here http://tbutton.prnewswire.com/prn/11690X84636341 SOURCE Guilford Pharmaceuticals Inc. CONTACT: Stacey Jurchison, 410-631-5022, or cellular, 410-274-5266, or Angie Rubin, 410-631-6449, both of Guilford Pharmaceuticals/ |
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| aus der Diskussion: | GUILFORD PHARMACEUTICALS - PART III |
| Autor (Datum des Eintrages): | Maiestro (06.06.01 17:12:56) |
| Beitrag: | 9 von 66 (ID:3677776) |
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