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Date: 11/24/2004
Disease: General Cancer
NewsRx.com
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Allos Therapeutics, Inc. (ALTH) announced the presentation of updated results from its phase 3 clinical trial of the investigational radiation sensitizer Efaproxyn (efaproxiral) in patients with brain metastases.
Preliminary data from the phase 3 study, called REACH, were first announced in April 2003. John H. Suh, MD, director, Gamma Knife Center, clinical director, Radiation Oncology, Brain Tumor Institute at the Cleveland Clinic Foundation, and the study's lead investigator, presented the findings in an oral presentation at the 29th Annual Meeting of the European Society for Medical Oncology.
In abstract #785, titled "Standard Whole Brain Radiation Therapy (WBRT) Plus Supplemental Oxygen (O2) with or without Efaproxiral (Efaproxyn) in Patients with Brain Metastases: Updated Survival Results of the Randomized REACH (RT-009) Study," Suh and colleagues presented an updated survival analysis of enrolled patients from the time of randomization until death or January 2004, whichever occurred first.
Results of the analysis indicated that the addition of Efaproxyn to whole brain radiation therapy (WBRT) led to a significant reduction in the risk of death for the co-primary patient populations (all eligible patients and all eligible lung and breast patients), consistent with results reported previously. Specifically, there was a 21% (95% confidence interval: 5%-35%) and 23% (95% confidence interval:I:5%-38%) reduction in the risk of death, for all eligible patients and all eligible lung and breast cancer patients respectively. Moreover, Suh's analysis affirmed a distinct survival benefit for patients with brain metastases originating from breast cancer in the Efaproxyn arm. Two-year survival for breast cancer patients was 17% in the Efaproxyn arm as compared to 0% in the control arm.
To further confirm the survival benefit observed in the breast cancer sub- group, in February 2004, Allos initiated a phase 3, randomized, open-label, multi-center trial, called ENRICH (ENhancing Whole Brain Radiation Therapy In Patients with Breast Cancer and Hypoxic Brain Metastases), designed to compare the effect of whole brain radiation therapy (WBRT) with supplemental oxygen with or without Efaproxyn in women with brain metastases from breast cancer. Allos is currently enrolling patients in the ENRICH study at leading cancer centers across North America and expects to expand enrollment to Europe and South America shortly.
The REACH study was a randomized, open label phase 3 clinical trial designed to demonstrate the safety and efficacy of Efaproxyn in treating patients with brain metastases and good performance status. Patients with non- small cell lung cancer, germ cell tumors or lymphoma were excluded. Prior brain tumor resection was allowed as long as measurable lesion(s) remained. The study enrolled 538 patients and compared the safety and efficacy of Efaproxyn plus WBRT and supplemental oxygen (271 patients) versus WBRT and supplemental oxygen (267 patients) alone in patients with brain metastases. The primary endpoint of the trial was survival.
Efaproxyn (efaproxiral) is the first synthetic small molecule designed to "sensitize" hypoxic (oxygen-deprived) areas of tumors during radiation therapy by facilitating the release of oxygen from hemoglobin, the oxygen-carrying protein contained within red blood cells, and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy in the treatment of cancer. By increasing tumor oxygenation at the time of treatment, Efaproxyn has the potential to enhance the efficacy of standard radiation therapy. Unlike chemotherapeutics or other radiation sensitizers, Efaproxyn does not have to cross the blood brain barrier or enter the tumor to be effective.
Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing drugs for improving cancer treatments. This article was prepared by Biotech Week editors from staff and other reports. Copyright 2004, Biotech Week via NewsRx.com & NewsRx.net.
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