Allos Therapeutics' Pralatrexate Granted Orphan Medicinal Product Designation for the Treatment of Hodgkin Lymphoma by the Eu...

Allos Therapeutics, Inc. (Nasdaq: ALTH) announced today that the European Commission (EC) has granted orphan medicinal product designation for pralatrexate for the treatment of Hodgkin lymphoma (HL). The Company is currently investigating pralatrexate in a number of ongoing studies, including a Phase 2 clinical study in patients with relapsed or refractory non-Hodgkin lymphoma or Hodgkin lymphoma. The EC previously granted orphan designations for pralatrexate for the treatment of patients with peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and non-papillary transitional cell carcinoma (TCC) of the urinary bladder, a form of bladder cancer.

Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics, said: “The orphan medicinal product designation represents another important regulatory achievement for Allos and further strengthens our global development strategy for pralatrexate in patients with hematologic malignancies.”

The European orphan medicinal product designation is intended to promote the development of drugs that may provide significant benefit to patients suffering from rare diseases identified as life-threatening or very serious. Under EC legislation, orphan medicinal product designation provides ten years of potential market exclusivity once the product candidate is approved for marketing for the designated indication in the European Union. Orphan medicinal product designation also allows for protocol assistance free of charge on clinical trials, a reduced Marketing Authorisation Application (MAA) filing fee and the potential for grant funding. This designation is based on a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).

About Hodgkin Lymphoma (HL)

Hodgkin lymphoma is a type of cancer of the lymphatic system, a network of vessels that transport fluid from tissues through the lymph nodes and into the bloodstream. Because lymph nodes are found throughout the body, the cancer can begin in almost any part of the body. Many people with HL can be cured if the disease is found and treated early. However, despite the treatments available, HL remains a serious and life-threatening disease, mainly because it is associated with poor survival in patients whose disease does not respond to treatment or has come back after previous treatment. HL affects approximately 1.1 in 10,000 people in the European Union.*1 The National Cancer Institute estimated that approximately 8,490 new cases of HL were expected to be diagnosed in the United States in 2010.

About Allos Therapeutics

Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics. Allos is currently focused on the development and commercialization of FOLOTYN® (pralatrexate injection), a folate analogue metabolic inhibitor. FOLOTYN is the first and only drug approved in the U.S. for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. Allos is also developing FOLOTYN in other hematologic malignancies and solid tumors. Allos retains exclusive worldwide rights to FOLOTYN for all indications. Allos is headquartered in Westminster, CO. For additional information, please visit www.allos.com.

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 regarding the Company’s intent to develop and conduct clinical trials for pralatrexate for the treatment of patients with Hodgkin lymphoma; 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. Important factors that may cause actual results to differ materially include, but are not limited to, that the Company may experience difficulties or delays in the initiation, progress or completion of its clinical trials, whether caused by competition, adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues or other factors; and that the Company may lack the financial resources and access to capital to fund ongoing or planned clinical trials for pralatrexate or any of its other product candidates, or to continue evaluating their therapeutic utility in other potential indications. 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2010, 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.

*Disclaimer: For the purpose of the designation, the number of patients affected by the condition is estimated and assessed on the basis of data from the European Union (EU 27), Norway, Iceland and Liechtenstein. This represents a population of 506,500,000 (Eurostat 2010).

Source:

1European Medicines Agency Committee for Orphan Medicinal Products Public summary of opinion on orphan designation, Pralatrexate for the treatment of Hodgkin lymphoma.