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Published on 6/14/2006 in the Prospect News Biotech Daily.

Allos says high exposure to Efaproxyn extends survival in brain metastases patients

By Elaine Rigoli

Tampa, Fla., June 14 - Allos Therapeutics, Inc. announced the publication of new findings from its phase 3 Reach study of Efaproxyn (efaproxiral) plus whole brain radiation therapy in patients with brain metastases from various primary cancers.

Results of the analysis found that patients who achieved sufficient efaproxiral exposure to realize the desired pharmacodynamic effect saw clinically meaningful survival and response rate benefits.

Patient outcomes were assessed based on primary tumor type and patient body weight. Patients who received at least seven of 10 doses were categorized into high or low exposure groups based on their efaproxiral red blood cell concentration.

Patients with efaproxiral concentrations of at least 483 mcg/mL were categorized to the high-exposure group; patients with efaproxiral concentrations of less than 483 mcg/mL were categorized to the low-exposure group.

Results of the analysis indicated that patients in the high-exposure group demonstrated increased survival and response rates relative to patients in the low-exposure group and control arm, according to a news release.

For patients with brain metastases from breast cancer, the median survival time was 25.7 months for patients in the high-exposure group relative to 7.3 months for low-exposure patients and 4.47 months for control patients.

Response rates in the breast cancer subset were 79.2%, 77.3% and 50.0% in the high-exposure, low-exposure and control groups, respectively.

Importantly, a majority of patients in the breast cancer subset achieved the target efaproxiral concentration of 483 mcg/mL, and thus demonstrated superior efficacy results, the release said.

Patients with brain metastases from non-small cell lung cancer who were categorized to the high-exposure group also demonstrated longer survival and better response rates relative to those with low exposure.

Allos Therapeutics is a biopharmaceutical company located in Westminster, Colo.


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