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=0.01). 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=0.018, 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, M.D. 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, Ph.D., Senior Vice President and Chief Scientific Officer of MGI PHARMA.
About Gliadel® 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.
About MGI PHARMA
MGI PHARMA, INC. is an oncology- and acute care-focused biopharmaceutical company that acquires, researches, develops and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA markets Aloxi® (palonosetron hydrochloride) Injection and Gliadel® Wafer (polifeprosan 20 with carmustine implant) in the United States. The Company directly markets its products in the U.S. and collaborates with partners to reach international markets. International distribution partners for Gliadel Wafer include: Link Pharmaceuticals Ltd. in the United Kingdom and the Republic of Ireland, Link Pharmaceuticals EU Ltd. in France and Germany, Dompe Farmaceutici s.p.a. in Italy, Laboratorios del Dr. Esteve S.A. in Spain and Portugal, Genesis Pharma S.A. in Greece, BioPro Pharmaceuticals Ltd. in South East Asia, PharmaPlan Pty Ltd. in South Africa and Medison Pharma Ltd. in Israel.
For more information about MGI PHARMA, please visit www.mgipharma.com.
This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements are not guarantees of MGI PHARMA's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause MGI PHARMA's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the ability of MGI PHARMA's product candidates to be proven safe and effective in humans, to receive marketing authorization from regulatory authorities, and to ultimately compete successfully with other therapies; continued sales of MGI PHARMA's marketed products; development or acquisition of additional products; reliance on contract manufacturing; changes in strategic alliances; continued access to capital; ability of MGI PHARMA to successfully complete the integration of Guilford with its existing operations; the risk that the perceived advantages of the Guilford transaction may not be achieved; and other risks and uncertainties detailed from time to time in MGI PHARMA's filings with the Securities and Exchange Commission including its most recently filed Form 10-Q or 10-K. MGI PHARMA undertakes no duty to update any of these forward-looking statements to conform them to actual results.