Surasek Phuphanich, MD, of Emory University's Winship Cancer Institute in Atlanta, GA, is principal investigator in a Phase 3, randomized, open-label trial called ENRICH (Enhancing Whole Brain Radiation Therapy In Patients with Breast Cancer and Hypoxic Brain Metastases). The trial is designed to compare the effects of whole brain radiation therapy with or without Efaproxyn (TM) (efaproxiral) in women with brain metastases originating from breast cancer. Enrollment in this global study is currently ongoing at Emory Winship and other leading cancer centers across North America.
Efaproxyn is a radiation sensitizer in clinical development that has the potential to improve the effectiveness of whole brain radiation therapy (WBRT) for the treatment of brain metastases originating from breast cancer. Results from a prior Phase 3 study showed that the addition of Efaproxyn to WBRT significantly improved survival among patients with metastatic breast cancer.
WBRT for the treatment of brain metastases is administered to approximately 175,000 patients per year in the United States and is intended to prevent or reduce complications and increase survival. Cancers that metastasize to the brain most often originate in the breast, lungs, kidneys, colon, rectum, or melanomas in the skin. Breast cancer is the second most common cause of brain metastases after lung cancer, accounting for 14 percent to 20 percent of the total incidence of brain metastases.
"Participation in the ENRICH study may allow a woman to receive a therapy that has the potential to slow the progress of brain metastases," says Dr. Phuphanich. "Efaproxyn has shown promise in previous clinical trials, and we believe that the ENRICH clinical trial has the potential to confirm that this experimental therapy will increase the effectiveness of radiation therapy in women with brain metastases originating from breast cancer"
Clinical Trial Enrollment Information
The ENRICH study has guidelines for participation. To enroll you must have brain metastases from breast cancer. You will not be able to participate in the study if you have had any previous treatment for brain metastases, including brain surgery and any form of radiation therapy to the brain. During study treatment, you may continue to receive all therapies except chemotherapy. There are other enrollment criteria that your physician or study clinician will explain.
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About EFAPROYXN (TM)
EFAPROXYN (efaproxiral) is the first synthetic small molecule designed to "sensitize" hypoxic (oxygen-deprived) areas of tumors prior to 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.
About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative drugs for improving cancer treatments. The company's lead clinical candidate, EFAPROYXN (TM), is a synthetic small molecule that has the potential to sensitize hypoxic (oxygen deprived) tumor tissues and enhance the efficacy of standard radiation therapy. In addition, Allos is developing PDX (pralatrexate), a novel small molecule cytoxic injectable antifolate (DHFR inhibitor) intended to treat non-small cell lung cancer, mesothelioma and non-Hodgkin's lymphoma. For more information, please visit the company's web site at: www.allos.com.