Guilford Pharmaceuticals Inc has filed a submission in Europe seeking an expanded indication for its innovative cancer therapy, Gliadel Wafer, for use during initial surgery for malignant glioma. Currently, Gliadel Wafer is approved in 24 countries, including the United States, for use during recurrent surgery for glioblastoma multiforme (GBM), a rapidly fatal form of malignant brain cancer, and in Canada for use in both primary and recurrent surgery for GBM.

Gliadel Wafer is a biodegradable wafer, implanted at the time of surgery that delivers chemotherapy directly to the tumor site, minimizing drug exposure to other areas of the body. Gliadel Wafer complements other standard therapies for brain cancer, such as surgery, radiation and traditional intravenous chemotherapy.

The European regulatory submission is based on favorable results from a randomized, double-blind, placebo-controlled Phase III clinical trial, which demonstrated a 30 per cent improvement in survival rates in patients who received Gliadel Wafer therapy at the time of their initial diagnosis and surgery for malignant glioma.

In the study, at one year, 59 per cent of patients given Gliadel Wafer were still alive compared to 48 per cent of those given placebo. A secondary endpoint in the study -- improvement in neurological symptoms -- also demonstrated a statistically significant benefit in the Gliadel Wafer treatment group.