Allos says interim analysis supports continuation of phase 3 trial of Efaproxyn for cancer

By Lisa Kerner

Erie, Pa., April 4 - Allos Therapeutics, Inc. said an independent data monitoring committee (DMC) has completed a planned interim analysis of data from the company's phase 3 Enrich trial with the synthetic molecule Efaproxyn (efaproxiral) and has recommended that the trial continue.

Enrich, a randomized, open-label, multi-center trial, is designed to compare the effect 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.

The interim review was triggered by the occurrence of 94 patient deaths and was based upon an evaluation of patients randomized through Feb. 14, according to a company news release.

The trial is expected to enroll 360 patients at up to 125 sites worldwide.

"This recommendation represents continued progress toward the completion of patient enrollment in Enrich and further validation of Efaproxyn's favorable safety profile," president and chief executive officer Paul L. Berns said in the release.

"We are pleased with the DMC's recommendation and are grateful for the support received from investigators and patients who enabled us to reach this milestone."

The DMC will conduct a second interim analysis of safety and efficacy data following the occurrence of 188 patient deaths, expected to occur in the second half of 2006.

Allos said if necessary, it will conduct the final analysis of safety and efficacy data following the occurrence of 282 patient deaths, expected to occur in the first half of 2007.

The company plans to submit an amendment to its previously filed New Drug Application to seek marketing approval for Efaproxyn for use as an adjunct to radiation therapy for the treatment of brain metastases originating from breast cancer depending on the results of the second and final analyses.

Allos is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. The company is located in Westminster, Colo.

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