FDA grants orphan drug designation to pralatrexate for treatment of advanced TCC of urinary bladder

Allos Therapeutics, Inc. (Nasdaq: ALTH) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to pralatrexate for the treatment of advanced or metastatic transitional cell carcinoma (TCC) of the urinary bladder, a form of bladder cancer. The Company is currently investigating pralatrexate in a Phase 2 clinical study in patients with advanced or metastatic relapsed TCC of the urinary bladder.

“We are pleased that the FDA has recognized the unmet medical need for effective new therapies for the treatment of patients with advanced or metastatic transitional cell carcinoma of the urinary bladder, which is a very difficult disease”

"We are pleased that the FDA has recognized the unmet medical need for effective new therapies for the treatment of patients with advanced or metastatic transitional cell carcinoma of the urinary bladder, which is a very difficult disease," said Paul L. Berns, president and chief executive officer. "This orphan drug designation supports our development strategy for pralatrexate, and we look forward to completing patient enrollment in our ongoing Phase 2 study of pralatrexate in this patient population."

The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. Under the Orphan Drug Act, the FDA will not accept or approve other marketing applications from other sponsors to market the identical active moiety for the same therapeutic indication for a seven-year period once a designated orphan drug is approved for marketing. In addition to potential market exclusivity, orphan drug designation provides potential protocol assistance, advice on the conduct of clinical trials, tax credits for clinical research expenses, grant funding for research of rare disease treatments and waiver of the Prescription Drug User Fee Act (PDUFA) filing fee for the drug's sponsor.