ALTH Allos Therapeutics, Inc. (MM)

Allos Therapeutics Announces Presentation of Phase 1 Results of PDX in Patients With Advanced Non-Small Cell Lung Cancer - Study of PDX in Combination With Paclitaxel or Docetaxel Yields Encouraging Results - BOSTON, Nov. 18 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. announced today the poster presentation of the results of a Phase 1 clinical trial of its antifolate compound PDX used in combination with paclitaxel (PTXL) or docetaxel (Taxotere(R) -- DTXL) in patients with non-small cell lung cancer (NSCLC). The study "Phase 1 study of 10-Propargyl-10-Deazaaminopterin (PDX) plus Docetaxel (DTXL) or Paclitaxel (PTXL) in Patients with Advanced Cancer," is being presented today at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics at the Hynes Center in Boston. Led by Dr. Christopher G. Azzoli of the Memorial Sloan-Kettering Cancer Center, the study indicates that PDX used in combination with DTXL at the doses studied is active, well tolerated and may warrant Phase 2 testing for patients with metastatic NSCLC, and other types of cancer where PDX demonstrates single-agent activity. Dose escalation in the study is ongoing. The primary objective of this study was to determine the Maximum Tolerated Dose (MTD) and toxicity profile of PDX when combined with paclitaxel (PTXL) or docetaxel (DTXL) in patients with solid tumors for whom PTXL or DTXL are considered acceptable treatment. Allos Therapeutics is planning to initiate a multi-site Phase 2 clinical trial with PDX in patients with NSCLC in the first half of 2004. Presenting the results of this Phase 1 study, Dr. Azzoli said, "We are encouraged by the results of this study, specifically in terms of the toxicity profile of PDX when combined with DTXL. Based on these preliminary results, we conclude that that PDX + DTXL + vitamin supplementation is active, and well tolerated. Adding vitamin supplements has allowed us to safely deliver PDX at a dose that approximates the single-agent maximum tolerated dose of PDX. Dose escalation in the study will continue, and we are interested in pursuing Phase 2 testing for patients with metastatic NSCLC and other tumor types where PDX and DTXL demonstrate single-agent activity." PDX (10-propargyl-10-deazaaminopterin) is an injectable small molecule cytotoxic agent that has a superior potency and toxicity profile relative to methotrexate and other related DHFR inhibitors. PDX is a more effective permeant and substrate for the folate transporter (RFC-1) and the enzyme FPGS than methotrexate, resulting in increased intracellular accumulation of polyglutamylated metabolites. In a Phase 2 trial in patients with metastatic non-small cell lung cancer previously treated with chemotherapy, PDX was found to have single-agent activity. About Allos Therapeutics 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: 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, alone or with MSKCC, to initiate, conduct and complete their planned clinical trials on schedule and in accordance with regulatory requirements, to adequately demonstrate the safety and efficacy of PDX for use as a chemotherapy treatment for patients with non-small cell lung cancer or any other type of cancer, and to adequately demonstrate a superior safety and efficacy profile of PDX relative to methotrexate and related antifolates and other competing chemotherapy agents, 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. DATASOURCE: Allos Therapeutics, Inc. CONTACT: Monique M. Greer VP, Corporate Communications and Investor Relations of Allos Therapeutics, Inc., +1-720-540-5241, ; or media, Fern Lazar of Lazar Partners Limited, +1-212-867-1765, for Allos Therapeutics, Inc. Web site: http://www.allos.com/

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