MGI Pharma Announces Results from Study Involving the Dual Implantation of Gliadel Wafer and Radioactive Seeds for Treatment of Recurrent Glioblastoma Multiforme
The study was led by Ronald E. Warnick, M.D., Chairman of the Mayfield Clinic and professor of neurosurgery at the University of Cincinnati. This is the first study ever conducted to evaluate the effect of these two novel agents used simultaneously in combination with surgery to treat recurrent GBM. The Phase 1/2 single-arm study explored the safety and efficacy of the localized therapies in 34 patients. The dual implantation of Gliadel Wafer and radioactive seeds was well-tolerated among patients and may contribute to longer survival than when surgery is coupled with either therapy alone. Additional controlled clinical trials will need to be conducted in order to confirm this finding and demonstrate a survival benefit in comparison to control.
"Recurrent glioblastoma is a challenging disease, because the tumor grows and spreads so quickly," Dr. Warnick said. "These results suggest that by simultaneous application of two localized therapies, Gliadel Wafer and radioactive seeds, we may be able to provide an improved survival benefit for this patient population. We will continue to conduct further studies of this approach for both recurrent and newly diagnosed glioblastoma."
About Gliadel(R) Wafer
Gliadel(R) (polifeprosan 20 with carmustine implant) Wafer is indicated in patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation. Gliadel is also indicated in patients with recurrent glioblastoma multiforme as an adjunct to surgery. Gliadel should not be given to individuals who have demonstrated a previous hypersensitivity to carmustine or any of the components of Gliadel. Patients undergoing craniotomy for malignant glioma and implantation of Gliadel should be monitored closely for complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema.
Communication between the surgical resection cavity and the ventricular system should be avoided to prevent the wafers from migrating into the ventricular system and causing obstructive hydrocephalus. If a communication larger than the diameter of a wafer exists, it should be closed prior to wafer implantation. Computed tomography and magnetic resonance imaging of the head may demonstrate enhancement in the brain tissue surrounding the resection cavity after implantation of Gliadel. This enhancement may represent edema and inflammation caused by Gliadel or tumor progression. The short-term and long-term toxicity profiles of Gliadel, when given in conjunction with chemotherapy have not been fully explored.
About MGI PHARMA
MGI PHARMA, INC. is a biopharmaceutical company focused in oncology and acute care that acquires, researches, develops, and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA markets Aloxi(R) (palonosetron hydrochloride) Injection, Dacogen(R) (decitabine) for Injection, and Gliadel(R) 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. 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 determinations by FDA regarding the safety or efficacy of Gliadel Injection 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-K and Form 10-Q. MGI PHARMA undertakes no duty to update any of these forward-looking statements.
MGI PHARMA, INC.
Timothy J. Smith, 952-406-3100
Posted: January 2008