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Allos Therapeutics' PDX Granted Orphan Medicinal Product,Designation by the European Commission

WESTMINSTER, Colo., April 19, 2007 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. today announced that the Commission of the European Communities, with a favorable opinion of the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA), has granted orphan drug designation to the Company's novel antifolate PDX (pralatrexate) for the treatment of patients with peripheral T-cell lymphoma (PTCL). In July 2006, the U.S. Food and Drug Administration (FDA) awarded orphan drug designation to PDX for the treatment of patients with T-cell lymphoma. In October 2006, the FDA granted fast track designation to PDX for the treatment of patients with T-cell lymphoma.

"This designation underscores the critical need for new therapies to treat peripheral T-cell lymphoma and reinforces our belief that PDX has the potential to become an important therapeutic option for patients with this devastating disease," said Paul L. Berns, President and Chief Executive Officer.

The EMEA 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 EMEA guidelines, 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 provides potential protocol assistance, advice on the conduct of clinical trials, a reduced Marketing Authorization Application (MAA) filing fee for the drug's sponsor and the potential for grant funding.

PDX is currently the subject of PROPEL, a pivotal Phase 2, international, multi-center, open-label, single-arm study that will seek to enroll 100 evaluable patients with relapsed or refractory PTCL who have progressed after at least one prior treatmen
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