Treatment IND Approved For Gliadel

Guilford Pharmaceuticals Inc has received US Food and Drug Approval for its Treatment Investigational New Drug application on Gliadel wafer polymer implants (containing 7.7mg carmustine) for the treatment of malignant brain tumors.

In April, the results of Guilford's first Phase III clinical trial of Gliadel were published in The Lancet. In this placebo-controlled, double-blind study, 222 patients undergoing surgery for recurrent malignant glioma were enrolled. Use of the Gliadel wafer increased overall survival by approximately 35% compared to placebo, with no clinically-important adverse effects attributable to the product.

A second, placebo-controlled, double-blind Phase III trial in patients undergoing initial surgery for malignant glioma have been completed in Europe, coordinated by Guilford's partner, the Finnish company Orion. The results - which indicated dramatic survival improvements in brain cancer patients - were presented at the 11th International Conference on Brain Tumor Research and Therapy in Napa, California, USA, on November 1. These results are very important for the future treatment of brain cancer, according to lead investigator Henry Brem of Johns Hopkins.