GLFD Guilford Pharmaceuticals (MM)

Guilford Pharmaceuticals Presents New GLIADEL(R) Wafer Data at the Society for Neuro-Oncology Annual Meeting BALTIMORE, Nov. 22 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc. (NASDAQ:GLFD) today announced that new data for GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant) were presented on Saturday, November 20th at the Society for Neuro-Oncology (SNO) Annual Meeting in Toronto, Canada. The Society for Neuro-Oncology is regarded as the preeminent scientific society for clinical research on brain cancer. The data, which are part of a three-year, prospective patient registry called PROLONG(R), suggest that GLIADEL(R) may be useful in controlling local disease progression in patients with metastatic brain cancer. The frequency of metastatic brain cancer has increased in recent years and is estimated to occur in up to 40% of patients diagnosed with cancer. PROLONG(R), or Prospective Look at Outcomes Nationally with GLIADEL(R) Wafer, is a patient registry designed to capture prospective, observational data on the use of GLIADEL(R) in real-world clinical practice for the purpose of enhancing best practices in the management of brain cancer in patients receiving GLIADEL(R) as part of a multi-modal treatment regimen. Data in the PROLONG(R) registry were collected prospectively from December 2001 until December 2003. During this period a total of 322 patients were enrolled in the registry, beginning at the time of their first post-operative visit. They were then followed at 3-month intervals until death or loss to follow-up. The data presented at the Society for Neuro-Oncology annual meeting reported the results of a prospective analysis of 30 patients with metastatic brain cancer (representing 11% of the patients in the registry) who received therapy with GLIADEL(R) in addition to surgical resection and other therapies. After a median follow-up period of 27 weeks, 9 patients had died and disease progression was reported in 8 patients. Of the patients who experienced a recurrence, the data show that there was no evidence of local recurrence at the tumor resection site, while 7 patients experienced distal recurrence in the central nervous system. The recurrence location for 1 patient was unavailable. Dr. Matthew Meldorf, Senior Director of Medical Affairs for Guilford, commented, "So far, there has been very little published data describing the use of GLIADEL(R) in patients with metastatic brain cancer. The data from the PROLONG(R) registry reveal low local rates of disease recurrence when GLIADEL(R) is employed along with other therapies, suggesting a role for GLIADEL(R) in the management of metastatic disease. Two additional published studies provide further evidence of low local recurrence rates when GLIADEL is used in combination with initial surgical resection of CNS metastases and other therapies, however, randomized, controlled clinical trials are needed to confirm these findings before any conclusions about efficacy can be drawn." About GLIADEL(R) Wafer GLIADEL(R) Wafer is the only marketed cancer treatment capable of delivering chemotherapy directly to the site of a brain tumor, bypassing the blood-brain barrier and minimizing drug exposure to other areas of the body. GLIADEL(R) Wafer is a small, white to off-white dime-sized wafer comprised of a biodegradable polymer (polifeprosan 20) incorporating 7.7 mg. of carmustine (BCNU), a chemotherapeutic agent usually administered intravenously to treat a malignant glioma. Up to eight GLIADEL(R) Wafers can be implanted in the cavity created when a surgeon removes a brain tumor. There, they slowly dissolve, releasing BCNU directly to the tumor site in high concentrations, while minimizing drug exposure to other areas of the body. Additional information on GLIADEL(R) Wafer is available at http://www.gliadel.com/. For full prescribing information, please see http://www.guilfordpharm.com/, under Products / Marketed Products / GLIADEL(R) Wafer. Important Information About GLIADEL(R) Wafer GLIADEL(R) Wafer is indicated in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation. GLIADEL(R) Wafer is also indicated in recurrent glioblastoma multiforme patients as an adjunct to surgery. The following four categories of adverse events are possibly related to treatment with GLIADEL(R) Wafer during initial resection. Frequencies are listed of events that occurred in a randomized trial of GLIADEL(R) Wafer and placebo, respectively: seizure (33.3% vs. 37.5%); brain edema (22.5% vs. 19.2%); healing abnormalities (15.8% vs. 11.7%); and intracranial infection (5.0% vs. 6.0%). The following three categories of adverse events are possibly related to treatment with GLIADEL(R) Wafer for recurrent disease. Frequencies are listed of events that occurred in a randomized trial of GLIADEL(R) Wafer and placebo, respectively: post-operative seizure (19% vs. 19%); healing abnormalities (14% vs. 5%); intracranial hypertension (4% vs. 6%) and intracranial infection (4% vs. 1%). Patients undergoing craniotomy for malignant glioma and implantation of GLIADEL(R) Wafer should be monitored closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema. Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with GLIADEL(R) Wafer, including one case leading to brain herniation. 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. The short- and long-term toxicity profiles of GLIADEL(R) Wafer when given in conjunction with radiation or chemotherapy have not been fully explored. About Guilford Guilford Pharmaceuticals Inc. is a pharmaceutical company engaged in the research, development and commercialization of proprietary drugs that target the hospital and neurology markets. Presently, Guilford markets two commercial products, GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant), for the treatment of brain cancer, and AGGRASTAT(R) Injection (tirofiban hydrochloride), a glycoprotein GP IIb/IIIa receptor antagonist for the treatment of acute coronary syndrome (ACS). Guilford's product pipeline includes a novel anesthetic, AQUAVAN(R) Injection, and drugs for treating Parkinson's disease and peripheral nerve injury. For additional prescribing information about GLIADEL(R) and AGGRASTAT(R) please see http://www.guilfordpharm.com/, under Products / Marketed Products. Contact: Guilford Pharmaceuticals Inc. Stacey Jurchison 410.631.5022 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 Quarterly Report on Form 10-Q filed with the SEC on November 8, 2004, that could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. DATASOURCE: Guilford Pharmaceuticals Inc. CONTACT: Stacey Jurchison, Guilford Pharmaceuticals Inc., +1-410-631-5022 Web site: http://www.guilfordpharm.com/ http://www.gliadel.com/ Company News On-Call: http://www.prnewswire.com/comp/112882.html

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