Gliadel Used in Initial Malignant Glioma Surgery Increases Survival

December 1, 1995

BALTIMORE--Guilford Pharmaceuticals Inc.'s Gliadel biodegradable polymer implants significantly increased survival in a study of 32 patients with malignant glioma undergoing initial surgery. Gliadel wafers or placebo were inserted into the surgical cavity created when the brain tumor was removed, followed 3 weeks later by standard radiation therapy.

BALTIMORE--Guilford Pharmaceuticals Inc.'s Gliadel biodegradablepolymer implants significantly increased survival in a study of32 patients with malignant glioma undergoing initial surgery.Gliadel wafers or placebo were inserted into the surgical cavitycreated when the brain tumor was removed, followed 3 weeks laterby standard radiation therapy.

As the wafer slowly dissolves in the brain, it releases carmustinedirectly to the tumor site in high concentrations over an extendedperiod of time.

In this randomized double-blind phase III study, 63% of the Gliadel-treatedpatients were alive 1 year after treatment, compared with 19%of placebo recipients. At 2 years, the figures were 31% and 6%,respectively.

The study, reported at the 11th International Conference on BrainTumor Research and Therapy in Napa, Calif, was coordinated byGuilford's Scandinavian partner, Orion-Farmos Corporation, andled by Dr. Simo Valtonen, of Turku University Central Hospital,Finland.

In a US phase III study, Gliadel was shown to extend survivalin patients with recurrent malignant glioma. Gliadel is currentlyavailable under a Treatment IND to US patients.

In other news, Guilford announced that it has licensed exclusiveworldwide rights to a novel proprietary polyanhydride polymerfrom Yissum Research Development Corporation of the Hebrew Universityof Jerusalem.