ALTH Last 2.41 High 2.6 Low 2.35 وهذا نص الخبر Allos Therapeutics Submits First Component of Rolling New Drug Application for RSR13 for the Treatment of Brain Metastases From Breast Cancer 8/5/2003 6:00:00 AM WESTMINSTER, Colo., Aug 5, 2003 /PRNewswire-FirstCall via COMTEX/ -- Allos Therapeutics, Inc. (ALTH) today announced that it has begun submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the company's investigational radiation sensitizer, RSR13 (efaproxiral), for the treatment of patients with breast cancer that has metastasized to the brain. The electronic submission was produced in the Common Technical Document format, which is an internationally agreed upon format that facilitates regulatory review in the USA, Europe and Japan. The submission will occur on a "rolling" basis and is expected be completed by the end of the year. The first component submitted contained the nonclinical section, consisting of one CD-ROM containing 40 volumes and over 6,900 pages of data and analysis. The chemistry, manufacturing and controls (CMC) and the clinical modules will be submitted later this year. When complete, the NDA submission will contain safety and efficacy data from over 700 patients treated under 17 RSR13 study protocols and will be based largely on the company's recently completed pivotal Phase 3 clinical trial, one of the largest randomized studies ever conducted in patients with brain metastases. The submission will also include supporting data from three Phase 2 studies of RSR13 in patients with brain metastases, primary non-small cell lung cancer and glioblastoma multiforme. "The submission of the first section of our NDA to the FDA is an extremely gratifying milestone for an emerging company like Allos," said Michael E. Hart, President and CEO of Allos Therapeutics, Inc. "There is clearly an unmet medical need for new treatments that can provide better local control of brain metastases while extending survival. This hypothesis was confirmed by the results of the Phase 3 trial, demonstrating a significant survival benefit in patients with metastatic breast cancer. Our goal is to get RSR13 into the hands of oncologists that treat patients as quickly as possible. To help facilitate this process, we are in ongoing discussions with the FDA regarding future development of RSR13 as a radiation sensitizer." An estimated 211,300 women and 1,300 men will be diagnosed with breast cancer in the USA in 2003. Approximately 20-to-30 percent of breast cancer patients will develop brain metastases. Brain metastases, the most common type of brain cancer, are tumors that have spread to the brain from a malignant tumor in another part of the body. This condition occurs in approximately one out of five cancer patients, most often in patients with breast cancer or non-small cell lung cancer. There are approximately 175,000 annual cases of brain metastases in the USA. Standard whole brain radiation is the primary palliative therapy for treating patients with brain metastases and it has been shown to prevent or reduce complications and to increase survival. Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative drugs for improving cancer treatments. The company's lead clinical candidate, RSR13 (efaproxiral), 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, a novel small molecule cytotoxic injectable antifolate (DHFR inhibitor) being developed for 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 . This announcement contains forward-looking statements that involve risks and uncertainties. Future events may differ materially from those discussed herein due to a number of factors, including, but not limited to, risks and uncertainties related to the company's ability to complete the submission of its NDA to the FDA on schedule and in accordance with regulatory requirements, to adequately demonstrate the safety and efficacy of RSR13 for use as a radiation sensitizer in the treatment of metastatic breast cancer and any other type of cancer, and its ability to obtain regulatory approval for RSR13, as well as other risks and uncertainties detailed from time to time in the company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2002. All forward-looking statements are based on information currently available to the company on the date hereof, and the company assumes no responsibility to update such statements. SOURCE Allos Therapeutics, Inc. Monique M. Greer, VP, Corporate Communications and Investor Relations of Allos Therapeutics, Inc., +1-720-540-5241, firstname.lastname@example.org http://www.allos.com Copyright (C) 2003 PR Newswire. All rights reserved.