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.
As the wafer slowly dissolves in the brain, it releases carmustine
directly to the tumor site in high concentrations over an extended
period of time.
In this randomized double-blind phase III study, 63% of the Gliadel-treated
patients were alive 1 year after treatment, compared with 19%
of placebo recipients. At 2 years, the figures were 31% and 6%,
The study, reported at the 11th International Conference on Brain
Tumor Research and Therapy in Napa, Calif, was coordinated by
Guilford's Scandinavian partner, Orion-Farmos Corporation, and
led by Dr. Simo Valtonen, of Turku University Central Hospital,
In a US phase III study, Gliadel was shown to extend survival
in patients with recurrent malignant glioma. Gliadel is currently
available under a Treatment IND to US patients.
In other news, Guilford announced that it has licensed exclusive
worldwide rights to a novel proprietary polyanhydride polymer
from Yissum Research Development Corporation of the Hebrew University