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news.An independent data monitoring committee has recommended that Allos Therapeutics' phase III trial of Efaproxyn for women with brain tumors, should continue to final analysis after it reviewed data from the trial.
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The interim analysis was triggered by the occurrence of 188 patient deaths. The results of the analysis will not be made available to the company until the study is completed. No major patient safety concerns were identified by the monitoring committee.
The phase III trial is designed to evaluate the safety and efficacy of whole brain radiation therapy with supplemental oxygen with or without Efaproxyn in women with brain metastases originating from breast cancer. The primary endpoint of the trial is survival.
Allos will conduct the final analysis of safety and efficacy data from the 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, the company intends to submit an amendment to its previously filed new drug application to the FDA to seek marketing approval for Efaproxyn.