WESTMINSTER, Colo.--(BUSINESS WIRE)--Allos Therapeutics, Inc. (Nasdaq:ALTH) announced today that the European Commission (EC) has granted orphan medicinal product designation for pralatrexate for the treatment of cutaneous T-cell lymphoma (CTCL). The Company is currently investigating pralatrexate in a Phase 1 clinical study in patients with relapsed or refractory CTCL. In addition, the Company plans to conduct a Phase 3 clinical study comparing FOLOTYN in combination with systemic bexarotene versus systemic bexarotene alone in patients with CTCL who are refractory to at least one prior systemic therapy. Prior to initiation of the Phase 3 study, the Company will conduct a Phase 1 study to determine the maximum tolerated dose of the combination, which the Company plans to initiate in 2010. The EC previously granted orphan designations for pralatrexate for the treatment of patients with peripheral T-cell lymphoma (PTCL) and non-papillary transitional cell carcinoma (TCC) of the urinary bladder, a form of bladder cancer.
