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National Brain Tumor Awareness Week 2001 Innovative Wafer Therapy Has Enhanced Treatment Options, Renewed Hope (PR Newswire)This year more than 185,000 Americans will be diagnosed with primary or metastatic brain tumors, now the leading cause of solid tumor cancer death in children younger than age 20, and the third leading cause of cancer death in young adults between the ages of 20 to 39.- May 07 8:32 AM ET


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Posted on: 05/07/2001

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Press Release

SOURCE: Guilford Pharmaceuticals, Inc.

National Brain Tumor Awareness Week 2001; Innovative Wafer Therapy Has Enhanced Treatment Options, Renewed Hope

BALTIMORE, May 7 /PRNewswire/ -- This year more than 185,000 Americans will be diagnosed with primary or metastatic brain tumors, now the leading cause of solid tumor cancer death in children younger than age 20, and the third leading cause of cancer death in young adults between the ages of 20 to 39. However, hope exists in battling this devastating disease, thanks to revolutionary drug therapies that may prolong patient survival and improve the quality of each day for patients.

In an effort to raise awareness of the most promising treatments for brain tumors, and to encourage further clinical research and funding, the North American Brain Tumor Coalition (NABTC) has set aside this week, May 6-12, as National Brain Tumor Awareness Week. Previously not one of the most well known types of cancer, brain cancer is becoming nationally recognized through the help of grassroots awareness campaigns, patient advocacy and the NABTC's lobbying efforts to bolster research funding.

Among the most promising treatments for recurrent glioblastoma multiforme (GBM) -- the most rapidly progressive and fatal of all brain tumors -- is GLIADEL® Wafer (polifeprosan 20 with carmustine implant), the first new treatment to be approved for recurrent brain cancer in over 20 years. Since receiving approval from the FDA in 1996, its availability has enhanced the way GBM is treated, and has offered renewed hope to patients worldwide.

Developed and marketed by Guilford Pharmaceuticals, (Nasdaq: GLFD - news) GLIADEL® Wafer is a biodegradable polymer wafer, about the size of a dime -- that can be implanted following surgery to remove a brain tumor. GLIADEL® Wafer is designed to deliver the chemotherapeutic agent carmustine (BCNU) directly to the tumor site, allowing a higher dose than can be achieved by intravenous chemotherapy and minimizing drug exposure to the rest of the body.

"GLIADEL® Wafer is a unique treatment option that allows patients with certain forms of primary malignant brain cancer to benefit from localized chemotherapy without experiencing some of the side effects usually associated with systemic chemotherapy," commented Allan J. Hamilton, MD, FACS, head of the Department of Surgery at the University of Arizona College of Medicine. "We are particularly excited about the positive outcome of a recent Phase III first surgery clinical trial, which could expand the benefits of GLIADEL® Wafer therapy to a much larger patient population."

The Potential to Offer Hope to More Patients

A Phase III clinical trial of GLIADEL® Wafer for initial surgery, completed in June 2000, was conducted at 38 centers in 14 different countries. A total of 240 eligible men and women between the ages of 18 and 65 were randomly assigned to receive either GLIADEL® Wafer or placebo. In addition to treatment with either GLIADEL® Wafer or placebo, patients received standard therapy for malignant glioma, which included surgery and radiation therapy. The primary endpoint for the trial was overall survival.

Median survival in patients receiving GLIADEL® Wafer increased from 11.6 months for patients given placebo wafer to 13.9 months in patients given GLIADEL® Wafer (p<0.03). The p-value was determined using the logrank test, stratified by the country in which treatment was administered. At one year, 59 percent of patients given GLIADEL® Wafer were still alive compared to 48 percent of those given placebo (p<0.01).

Based on the results from this Phase III clinical trial, Guilford has submitted a supplemental New Drug Application with the United States Food and Drug Administration to seek approval to expand the labeled indication for GLIADEL® Wafer to include first line therapy in patients newly diagnosed with malignant glioma.

"Brain cancer is one of the most universally fatal and difficult-to-treat of all cancers," said Thomas Grahm, MD, Tyler Neurosurgical Associates, P.A., Tyler, TX. "Tumors in the brain grow rapidly and often recur after removal due to residual cancer cells embedded within the brain tissue. GLIADEL® Wafer offers promise because it can deliver chemotherapy directly to the tumor site, inhibiting re-growth."

GLIADEL® Wafer is approved to treat recurrent glioblastoma multiforme. It has generally been well tolerated. However, GLIADEL® 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® Wafer should be monitored closely for the following know complications of surgery: seizures, intracranial infections, abnormal wound healing, and brain edema. Each of these complications has been associated with GLIADEL® Wafer treatment.

About Brain Tumors

There are two types of brain tumors: primary and metastatic. Primary brain tumors originate in the brain, while metastatic brain tumors are formed by cancer cells that originated elsewhere in the body and then spread to the brain. There are several types of primary brain tumors. The most common forms are gliomas, which originate in the glial (structural) tissue of the brain and often cause headaches, seizures, memory loss and mood or behavior changes. Glioblastoma multiforme (GBM) tumors, the most common type of glioma, are grade IV tumors, making them one of the most rapidly progressive and universally fatal of all cancers.

The most common symptoms of brain tumors include, increasing pressure in the skull; headaches; drowsiness; nausea/vomiting; mental changes that cause memory and speech impairments; seizures; difficulty communicating, reasoning or concentrating; changes in behavior, temperament or interests; sensory problems, including vision and hearing difficulties; and paralysis, numbness or loss of coordination.

GLIADEL® Wafer is a registered trademark of Guilford Pharmaceuticals.

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 Brain Tumor Awareness Week, please visit http://www.paonline.com/nmlarson.

For more information about GLIADEL Wafer, visit www.gliadel.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, 1999, 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® Wafer in the U.S., Europe and elsewhere for treatment of patients with malignant glioma at the time of first surgery.

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SOURCE: Guilford Pharmaceuticals, Inc.

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