Allos Therapeutics, Inc announced that the European Medicines Agency (EMEA), with a positive opinion of the Committee for Orphan Medicinal Products, has granted orphan medicinal product designation to the company's novel antifolate, pralatrexate, for the treatment of non-papillary transitional cell carcinoma (TCC) of the urinary bladder, a form of bladder cancer. The company is currently investigating pralatrexate in a phase-2 study in patients with advanced or metastatic relapsed TCC of the urinary bladder. In April 2007, the EMEA granted orphan drug designation to pralatrexate for the treatment of patients with peripheral T-cell lymphoma.

"This additional orphan drug designation supports our global development strategy for pralatrexate," said Paul L Berns, president and chief executive officer of Allos Therapeutics. "We value the positive recognition from the EMEA of the unmet medical need for effective new therapies for the treatment of patients with bladder cancer. In addition, the orphan medicinal product designation further strengthens our program for pralatrexate by offering important clinical development and commercialization benefits."

Pralatrexate is a novel targeted antifolate designed to accumulate preferentially in cancer cells.

Allos Therapeutics is a biopharmaceutical company focused on developing and commercializing innovative small molecule drugs for the treatment of cancer.