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Allos Therapeutics Initiates Study of RH1 in Patients with Advanced Solid Tumors or non-Hodgkin's Lymphoma

WESTMINSTER, Colo., Nov. 12 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced the initiation of patient enrollment in a Phase 1, non-randomized, open-label, multi-center dose escalation study of the Company's targeted chemotherapeutic agent RH1 in patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL).

"We are pleased to advance the development of this agent," said Pablo J. Cagnoni, M.D., Chief Medical Officer of Allos. "RH1 is a small molecule chemotherapeutic agent that is bioactivated by the enzyme DT-diaphorase (DTD), which is over-expressed in many tumors, including lung, colon, breast and liver tumors. We believe that because RH1 is bioactivated in the presence of DTD, it has the potential to preferentially target certain tumors while limiting the amount of toxicity to normal tissue."

In this study, patients with either advanced solid tumors or NHL will receive a 3-hour intravenous (IV) infusion of RH1 administered once every 21 days. Patients will receive starting doses of RH1 at 1.5 mg/m2, with dose escalation in subsequent cohorts based on toxicity. Up to 60 evaluable patients will be enrolled in the study with the objective of determining the maximum tolerated dose (MTD), recommended Phase 2 dose and safety profile of RH1 in this population. Three to six patients will be enrolled per cohort. An expanded cohort of up to 24 evaluable patients who have tumor types with a high likelihood of DTD over-expression will be recruited to explore possible markers of anticancer activity. D. Ross Camidge, M.D., Ph.D., Assistant Professor of Medical Oncology at the University of Colorado Cancer Center, will serve as the study chair.

Information regarding this study is available at or the U.S. government's clinical trials database at

About Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma (NHL) is the most common hematological cancer and the fifth leading cause of cancer death in the U.S. An estimated 63,000 new cases of NHL will be diagnosed each year, of which peripheral T-cell lymphoma represents approximately 10 percent.

About Allos Therapeutics, Inc.

Allos Therapeutics, Inc. (ALTH) is a biopharmaceutical company focused on the development and commercialization of small molecule therapeutics for the treatment of cancer. The Company's lead product candidate, PDX (pralatrexate), is a novel antifolate currently under evaluation in a pivotal Phase 2 (PROPEL) trial in patients with relapsed or refractory peripheral T-cell lymphoma. The PROPEL trial is being conducted under an agreement reached with the U.S. Food and Drug Administration under its special protocol assessment, or SPA process. The Company is also investigating PDX in patients with non-small cell lung cancer and a range of lymphoma sub-types. The Company's other product candidate is RH1, a targeted chemotherapeutic agent that is currently being evaluated in a Phase 1 study in patients with advanced solid tumors or non-Hodgkin's lymphoma. For additional information, please visit the Company's website at

Safe Harbor Statement

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements relating to the potential safety and efficacy profile of RH1 for the treatment of advanced solid tumors, non-Hodgkin's lymphoma or any other type of cancer; the potential of RH1 to preferentially target certain tumors while limiting the amount of toxicity to normal tissue; and other statements that are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others: that the Company may experience delays in the completion of this Phase I trial, whether caused by competition, adverse events, patient enrollment rates, regulatory issues or other factors; that clinical trials may not demonstrate that RH1 is both safe and more effective than current standards of care; that data from preclinical studies and clinical trials may not necessarily be indicative of future clinical trial results; that the safety and/or efficacy results of clinical trials for RH1 will not support an application for marketing approval in the United States or any other country; and the risk that the Company may lack the financial resources and access to capital to fund future clinical trials for RH1 or any of its other product candidates. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2006 and in the Company's other periodic reports and filings with the Securities and Exchange Commission. 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 undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law.

Note: The Allos logo is a trademark of Allos Therapeutics, Inc.

SOURCE Allos Therapeutics, Inc.
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