Allos enrolls 360 women in phase 3 study of Efaproxyn in brain, breast cancer

By Lisa Kerner

Charlotte, N.C., Aug. 28 - Allos Therapeutics, Inc. said enrollment in its pivotal phase 3 Enrich study of Efaproxyn (efaproxiral) in women with brain metastases starting from breast cancer is complete.

The company said Efaproxyn, a synthetic small molecule, is designed to help increase the level of oxygen in tumors, making radiation therapy more effective.

The randomized, open-label, multi-center study is designed to evaluate the safety and efficacy of whole brain radiation therapy with supplemental oxygen with or without Efaproxyn. It is being conducted at 126 centers in the United States, Canada, Europe and South America.

Survival is the primary endpoint for the Enrich study, while secondary endpoints include response rate in the brain at three months, according to a company news release.

Allos said an independent data monitoring committee will conduct a second planned interim analysis of safety and efficacy data following the occurrence of 188 patient deaths, which is expected to occur in the second half of 2006.

A final analysis of safety and efficacy data will follow after 282 patient deaths, most likely in mid-2007.

Depending on the second interim and final results, Allos may submit an amendment to its previously filed New Drug Application seeking marketing approval for Efaproxyn.

Based in Westminster, Colo., Allos is a biopharmaceutical company developing small-molecule therapeutics for the treatment of cancer.

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