ALLOS UPDATES STATUS OF BRAIN CANCER TRIAL

Allos Therapeutics announced that an independent data monitoring committee (DMC) has completed a second planned interim analysis of data from the company's pivotal Phase III ENRICH trial of Efaproxyn (efaproxiral) plus whole-brain radiation therapy in women with brain metastases originating from breast cancer, and has recommended that the trial continue to the final efficacy analysis. The interim analysis was triggered by the occurrence of 188 patient deaths and was based on an evaluation of patients randomized through July. In order to protect the integrity of the trial, the results of the efficacy analysis will not be made available to the company until the study is completed. No major patient safety concerns were identified by the DMC.

The trial is a randomized, open-label, multicenter study designed to evaluate the safety and efficacy of with supplemental oxygen with or without Efaproxyn in women with brain metastases originating from breast cancer. Patient enrollment in the trial was completed in August, with a total of 368 patients enrolled at 78 medical centers in the United States, Canada, Europe and South America.

The primary endpoint of the trial is survival. Secondary endpoints include response rate in the brain at three months, Karnofsky Performance Status, and neurologic signs and symptoms assessment. 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.

The company will conduct the final analysis of safety and efficacy data from the ENRICH trial following the occurrence of 282 patient deaths, which is currently expected to occur in mid-2007. If the trial is deemed to be positive at the final analysis, the company intends to submit an amendment to its previously filed new drug application (NDA) to the FDA to seek marketing approval for Efaproxyn for use as an adjunct to radiation therapy for the treatment of brain metastases originating from breast cancer.