Allos' Efaproxyn boosts effects of radiation in brain cancer study

By Angela McDaniels

Seattle, Jan. 3 - Allos Therapeutics Inc. said results from a phase 3 study of Efaproxyn (efaproxiral) suggest that the addition of Efaproxyn to whole-brain radiation therapy may improve survival and response rates in patients with brain metastases, particularly those from breast cancer.

Among 397 patients with non-small cell lung cancer or breast cancer, those who received Efaproxyn experienced an improvement in both response rate and median survival time: median survival time was 6 months for the Efaproxyn group versus 4.4 months in the control arm, the company said.

A Cox multiple regression analysis conducted to account for known predictors of survival in this heterogeneous patient population demonstrated a 25% reduction in the risk of death for patients in the Efaproxyn arm, and a statistically significant improvement (13%) in response rate was also observed for patients in the Efaproxyn group.

Results of the study were reported in the Jan. 1 edition of the Journal of Clinical Oncology.

"Our findings suggest that Efaproxyn has the potential to improve the survival of a group of patients with an otherwise very poor prognosis," lead investigator John H. Suh of the Cleveland Clinic Foundation said in a company news release.

"Results of this study are particularly compelling in light of the lack of progress made by the field over the past 25 years in extending the survival and quality of life of this patient population."

To further confirm the survival benefit observed in the trial, the company began a randomized, open-label, multi-center phase 3 trial designed to compare the effect of whole-brain radiation therapy with supplemental oxygen with or without Efaproxyn in women with brain metastases from breast cancer. The company said it expects to complete patient enrollment in the phase 3 trial during the second half of 2006 and report preliminary results six months thereafter.

Allos said Efaproxyn is the first synthetic small molecule designed to sensitize oxygen-deprived areas of tumors during radiation therapy by facilitating the release of oxygen from hemoglobin and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy, the company said.

Allos is a biopharmaceutical company based in Westminster, Colo., that develops and commercializes small molecule therapeutics for the treatment of cancer.

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