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Phase III Open Label Study of Efaproxiral in Women With Brain Metastases Launched
WESTMINSTER, Colo., Feb. 12 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. today announced that it has launched a multi-center Phase 3 randomized open label trial of RSR13 (efaproxiral) as an adjunct to whole brain radiation therapy for the treatment of brain metastases from breast cancer. The study will seek to enroll approximately 360 patients at up to 50 cancer centers across North America. The management of Allos Therapeutics will be available to discuss this announcement during its fourth quarter and year-end financial results conference call at 11 a.m. EST today.
On February 2, 2004 the U.S. Food and Drug Administration (FDA) accepted for priority review the company's New Drug Application (NDA) to market RSR13 as an adjunct to whole brain radiation therapy for the treatment of brain metastases from breast cancer. The FDA has established a target date of June 4, 2004 to take action on the NDA.
"We are committed to expanding the body of clinical data in support of RSR13 and believe it is prudent to launch this study now, even as the FDA reviews our NDA on a priority basis," said Michael E. Hart, President and CEO of Allos Therapeutics, Inc. "Our findings to date suggest that RSR13, when combined with whole brain radiation therapy, is an important advance in the treatment of patients with brain metastases for whom there are few therapeutic options."
The Phase 3 study, called ENRICH (ENhancing Whole Brain Radiation Therapy In Patients with Breast Cancer and Hypoxic Brain Metastases), is designed to compare the effect of WBRT with supplemental oxygen with or without RSR13 in women with brain metastases from breast cancer. This trial will also evaluate the safety profile of RSR13 in this patient population. The design of the study calls for two interim analyses for safety and efficacy. The company has successfully completed the Special Protocol Assessment (SPA) of the ENRICH trial. Under SPA, the FDA evaluates whether the protocol for a clinical trial is adequate to meet scientific and regulatory requirements for marketing approval of the drug by the FDA.
The National Breast Cancer Coalition (NBCC) is partnering with Allos to support trial enrollment and to gain additional insight about how to improve radiation treatment for women with brain metastases from breast cancer. Through its Clinical Trials Initiative, the NBCC is mobilizing its nation-wide network of advocates to inform women about this trial. "The National Breast Cancer Coalition has long said that clinical trials which ask the right questions are absolutely necessary to arrive at the best treatments and to end breast cancer," commented Fran Visco, President of NBCC. "We believe the ENRICH study will answer important questions, and we are committed to working with Allos to help with oversight and enrollment of patients for the trial."
NBCC is made up of more than 600 organizations representing several million patients, professionals, families and friends. Its main goals are to increase federal funding for breast cancer research and collaborate with the scientific community to implement new models of research; improve access to high quality health care and breast cancer clinical trials for all women; and expand the influence of breast cancer advocates in all aspects of the breast cancer decision making process. Additional information about NBCC can be found at http://www.stopbreastcancer.org/.
RSR13 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, RSR13 has the potential to enhance the efficacy of standard radiation therapy. Unlike chemotherapeutics or other radiation sensitizers, RSR13 does not have to cross the blood brain barrier or enter the tumor to be effective.
Source: Allos Therapeutics, Inc.