The wafers are placed after the surgical resection of the tumor
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Gliadel Wafer

The GLIADEL® Wafer is a small wafer that contains the chemotherapeutic drug carmustine, or BCNU. After a specific brain tumor called a high-grade malignant glioma is surgically removed, up to 8 GLIADEL® Wafers are implanted in the cavity the tumor once occupied, slowly delivering BCNU directly to the tumor site. Find out more about GLIADEL® Wafer.
GLIADEL® is marketed by MGI® pharma more...

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GLIADEL® Wafer is indicated in newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. GLIADEL® Wafer is also indicated in recurrent glioblastoma multiforme patients as an adjunct to surgery.

The technology of the biocompatible and biodegradable polymer that constitutes the "body" of the wafer was developed by the MIT (Massachussets Institute of Thecnology).

GLIADEL® Wafer and survival

A recent clinical study was conducted in 240 men and women undergoing initial surgery for a newly diagnosed high-grade malignant glioma. Each patient was randomly assigned to receive either surgery with implantation of GLIADEL® Wafer followed by radiation therapy, or surgery with implantation of placebo wafers (wafers without any BCNU) followed by radiation therapy.

The results in this study showed that survival was significantly prolonged in the patients who received GLIADEL® Wafer compared to those who received the placebo wafers: median survival—the length of time half of the patients in the study survived—increased to 13.9 months from 11.6 months.

Patients undergoing craniotomy and implantation of GLIADEL® Wafer for malignant glioma should be monitored closely for complications of craniotomy. During a randomized trial of GLIADEL® Wafer vs placebo implanted during initial resection, five categories of adverse events occurred that are possibly treatment-related: seizure (33.3% vs 37.5%); brain edema (22.5% vs 19.2%); healing abnormalities (15.8% vs 11.7%) including cerebrospinal fluid (CSF) leaks (5.0% vs 0.8%); intracranial hypertension (9.0% vs 2.0%); and intracranial infection (5.0% vs 6.0%). During a randomized trial of GLIADEL® Wafer vs placebo for recurrent disease, five categories of adverse events occurred that are possibly treatment-related: post-operative seizure (19.0% vs 19.0%); healing abnormalities (14.0% vs 5.0%); intracranial hypertension (4.0% vs 6.0%); brain edema (4.0% vs 1.0%); and intracranial infection (4.0% vs 1.0%).

Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with GLIADEL® Wafer, including one case leading to brain herniation. GLIADEL® Wafer contains carmustine and should not be given to patients who are allergic to carmustine. There are no studies assessing the reproductive toxicity of GLIADEL® Wafer. Carmustine can also cause fetal harm when administered to a pregnant woman.

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Guilford's Supplemental New Drug Application For GLIADEL(R) Wafer Accepted For Review By The FDA
From Market Wire,

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.

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.

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