Positive data on MGI Pharma's Gliadel

Study results published in the February issue of the Journal of Neurosurgery show that treatment of patients who have recurrent glioblastoma multiforme (GBM) with both MGI Pharma's Gliadel Wafer (polifeprosan 20 with carmustine implant) and radioactive seeds (iodine-125) at the time of tumor resection, may provide for a better outcome than treatment of patients with surgery and either agent alone.

The trial was led by Ronald Warnick, chairman of the Mayfield Clinic and professor of neurosurgery at the University of Cincinnati, USA. This is the first assessment ever conducted to evaluate the effect of these two novel agents used simultaneously in combination with surgery to treat recurrent GBM. The Phase I/II 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.

Dr Warnick said that "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."