ALLOS COMPLETES ENROLLMENT IN TRIAL OF BRAIN TUMOR TREATMENT

Allos Therapeutics has completed patient enrollment in its Phase III study of Efaproxtn (efaproxiral) in women with brain metastases originating from breast cancer.

The trial is a randomized, open-label, multicenter study designed to evaluate the safety and efficacy of whole brain radiation therapy with supplemental oxygen with or without Efaproxtn in women with brain metastases from breast cancer. A total of 360 patients were enrolled at 126 participating centers in the United States, Canada, Europe and South America. The primary endpoint for the study is survival. Secondary endpoints include response rate in the brain at three months. The trial is being conducted under a special protocol assessment, which is an agreement between the company and the FDA that the design and planned analyses of the study, as reflected in the trial protocol, adequately address the objectives of the study in support of a new drug application.

If the trial results are positive at either a second interim or final analysis, the company will submit an amendment to its previously filed new drug application as expeditiously as possible to seek marketing approval for the drug. Efaproxtn is the first synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, areas of tumors during radiation therapy by facilitating the release of oxygen from hemoglobin and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy.