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Patient Enrollment Completed in Phase 3 Trial of Efaproxiral in Women With Brain Metastases
ENRICH (ENhancing whole brain Radiation therapy In patients with breast Cancer and Hypoxic brain metastases) is a Phase 3, randomized, open-label, multi-center study designed to evaluate the safety and efficacy of whole brain radiation therapy (WBRT) with supplemental oxygen with or without EFAPROXYN 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 and KPS. 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 an NDA submission.
"We gratefully acknowledge the investigators and patients who participated in this landmark study for their important role in helping to evaluate the safety and efficacy of EFAPROXYN in women with brain metastases originating from breast cancer," said Paul L. Berns, President and Chief Executive Officer. "Brain metastases are a devastating complication of breast cancer that result in nearly uniform mortality. With the completion of enrollment in this pivotal Phase 3 trial, we are one step closer to introducing an important new first-in-class therapeutic option that has the potential to improve the survival and quality of life of this patient population."
An independent data monitoring committee will conduct a second planned interim analysis of safety and efficacy data from the study at its first scheduled meeting following the occurrence of 188 patient deaths, which is currently expected to occur in the second half of 2006. The Company will conduct the final analysis of safety and efficacy data following the occurrence of 282 patient deaths, which is currently expected to occur in mid 2007. If the trial results are positive at either the 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 EFAPROXYN for the treatment of patients with brain metastases originating from breast cancer.
EFAPROXYN 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, the oxygen-carrying protein contained within red blood cells, and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy. By increasing tumor oxygenation, the Company believes that EFAPROXYN has the potential to enhance the efficacy of standard radiation therapy.
Source: Allos Therapeutics