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Gliadel Wafer Demonstrates Long-Term Survival Benefit for Patients With High-Grade Malignant Gliomas

MINNEAPOLIS, M.N. -- March 9, 2006 -- MGI Pharma, Inc. announced the publication of long-term (56 month) follow-up data showing that GliadelŪ Wafer provides a durable long-term survival benefit for patients with high-grade malignant glioma.

Gliadel Wafer is approved by the FDA for treatment of patients with newly-diagnosed high-grade malignant glioma as an adjunct to surgery and radiation. Gliadel Wafer is also indicated to treat recurrent glioblastoma multiforme (GBM) in addition to surgery. The approval was based on clinical trial results showing the median survival of patients with high-grade malignant gliomas increased to 13.9 months from 11.6 months, and the median survival of patients with recurrent GBM increased to 6.4 months from 4.6 months.

The newly-published data in the March edition of The European Journal of Neurosurgery, Acta Neurochirurgica, reports long-term survival results from a previously published 240-patient, randomized, multi-center, placebo-controlled study.

This study demonstrated that patients treated with Gliadel Wafer in combination with radiation therapy had a significant survival advantage at three years compared with placebo (9.2% vs. 1.7%; P =.01). Of the 59 patients available for long-term follow-up, 11 were alive at 56 months (4.7 years). Of those 11 patients, nine had received Gliadel Wafer and two had received placebo wafers. Two of the nine remaining patients had GBM.

Treatment with Gliadel Wafer in patients with high grade malignant glioma was associated with a 27% reduction in risk of death over the study period (P =.018, log-rank statistic).

"We feel that the publication of this important data contributes significantly to the result of the randomized, placebo-controlled study, showing that patients with high-grade malignant gliomas have a better chance of long-term survival when treated with Gliadel Wafer," said Manfred Westphal, MD, of the University Hospital Eppendorf in Hamburg, Germany and lead investigator of the study.

"MGI Pharma is committed to advancing the treatment of high-grade malignant brain tumors and will continue to investigate ways in which our products can provide greater benefit to more cancer patients," said Mary Lynne Hedley, PhD, Senior Vice President and Chief Scientific Officer of MGI Pharma.

About GliadelŪ Wafer
Gliadel Wafer (polifeprosan 20 with carmustine implant) is a biodegradable wafer containing the chemotherapy agent carmustine, or BCNU, and is indicated in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation. Gliadel Wafer is also indicated in recurrent glioblastoma multiforme patients as an adjunct to surgery.

Gliadel Wafer provides localized delivery of chemotherapy directly to the site of the tumor and is the only FDA approved brain cancer treatment capable of doing so. Up to eight Gliadel wafers can be implanted in the brain after tumors are surgically removed. As a Gliadel wafer dissolves, BCNU is delivered directly to the site once occupied by the tumor, providing site-specific chemotherapy to target any remaining tumor cells.

Side effects that have been reported in patients receiving Gliadel Wafer include seizures, intracranial infections, abnormal wound healing, and brain edema (swelling). Although these events may result as a consequence of brain surgery (craniotomy) without Gliadel Wafer, they may occur more frequently when Gliadel Wafer is used. In clinical studies, the most common side effects that occurred more often in patients receiving Gliadel Wafer than in patients receiving placebo, included pain and abnormal wound healing. Certain side effects reported with intravenous delivery of BCNU have not been seen after implantation of Gliadel Wafer.


SOURCE: MGI Pharma

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