ALTH Allos Therapeutics, Inc. (MM)

Analysis From Phase 3 Trial Suggests That Some Non-Small Cell Lung Cancer Patients With Brain Metastases May Benefit From Allos Therapeutics' RSR13 (Efaproxiral) NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- Allos Therapeutics Inc. (NASDAQ:ALTH) announced that a retrospective analysis of the results from its Phase 3 trial of the investigational radiation sensitizer RSR13 (efaproxiral) in patients with brain metastases demonstrated a survival benefit in a group of patients with brain metastases originating from non-small cell lung cancer (NSCLC). Preliminary data from the Phase 3 study RT-009 called REACH, were first announced in April 2003. Abstract #7115, titled "Standard Whole Brain Radiation Therapy (WBRT) with supplemental oxygen (O2) with or without RSR13 (efaproxiral) in patients with brain metastases originating from NSCLC: Results of a subgroup analysis," was presented in a poster session on Saturday morning by Abdenour Nabid, MD, from the Centre Hospitalier Universitaire de Sherbrooke in Canada at the 40th Annual Meeting of the American Society of Clinical Oncology. Dr. Nabid also served as an investigator for the study. The REACH trial compared the median survival time (MST) of patients with brain metastases originating from select solid tumors receiving RSR13 (efaproxiral) and standard whole brain radiation therapy (WBRT) plus supplemental oxygen compared with a control group of patients receiving WBRT and supplemental oxygen alone. According to the abstract, Dr. Nabid's retrospective analysis indicated that patients who were diagnosed with brain metastases more than one month after they were diagnosed with NSCLC experienced a 31 percent reduction in the risk of death when treated with RSR13 (efaproxiral) compared with control. The analysis was conducted on the 299 NSCLC patients who enrolled in the REACH study and evaluated MST as a function of the time period between primary diagnosis of NSCLC and diagnosis of brain metastases. Patients in the RSR13 (efaproxiral) arm (n=75) who were diagnosed with primary NSCLC and brain metastases at least one month apart had a MST of 5.39 months compared with 4.37 months for controls (n=87), a 31 percent reduction in the risk of death for patients receiving RSR13 (efaproxiral) [HR=0.77, 95% CI (0.55, 1.09)]. MST for patients who had these diagnoses made within one month did not differ between the 2 treatment arms (RSR13 [efaproxiral] [n=73] 4.5 months; Control [n=64] 4.8 months). The abstract may be accessed online at http://www.asco.org/ at the conclusion of the meeting. "These results are very encouraging," Dr. Nabid observed. "Previous studies have reported that patients with brain metastases originating from NSCLC have different prognosis depending on the time between diagnosis of their primary tumors and diagnosis of their brain metastases. The results of this retrospective analysis suggest that RSR13 (efaproxiral) may provide clinical benefit to patients who have their primary and metastatic diagnoses made at least one month apart. These data support the further evaluation of RSR13 (efaproxiral) and WBRT in this patient population." "Data from ongoing analyses of the results of the REACH trial continue to support the potential clinical utility of RSR13 (efaproxiral) and WBRT in the treatment of brain metastases originating from solid tumors," said Michael E. Hart, President and CEO of Allos Therapeutics, Inc. The REACH study was a randomized, open label Phase 3 clinical trial designed to demonstrate that RSR13 is safe and effective for treating patients with brain metastases resulting from a variety of solid tumors. The study enrolled 538 patients and compared the safety and efficacy of RSR13 plus WBRT and supplemental oxygen (271 patients) versus VBRT and supplemental oxygen (267 patients) in patients with brain metastases. The primary endpoint of the trial was survival. About RSR13 (efaproxiral) RSR13 (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, RSR13 (efaproxiral) has the potential to enhance the efficacy of standard radiation therapy. Unlike chemotherapeutics or other radiation sensitizers, RSR13 (efaproxiral) 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, 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, an injectable small molecule chemotherapeutic agent that has enhanced potency and better toxicity profile relative to methotrexate and other dihydrofolate reductase, or DHFR, inhibitors. For more information, please visit the company's web site at: http://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 adequately demonstrate the safety and efficacy of RSR13 for the treatment of brain metastases from NSCLC or any other type of cancer, 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, 2003, as amended. Results from earlier clinical trials are not necessarily predictive of future clinical results. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. 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. DATASOURCE: Allos Therapeutics Inc. CONTACT: Fern Lazar of Lazar Partners Limited, +1-212-867-1762, Web site: http://www.asco.org/ http://www.allos.com/

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