Allos Therapeutics, Inc. announced 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.

"This orphan medicinal product designation further strengthens our global development strategy for pralatrexate in patients with T-cell lymphomas," said Paul L. Berns, president and chief executive officer of Allos Therapeutics. "CTCL is a devastating condition that greatly impacts patients' lives. To date, pralatrexate has demonstrated encouraging evidence of clinical activity in patients with relapsed or refractory CTCL and we look forward to continuing to advance the pralatrexate development program in this difficult-to-treat patient population."

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).

Allos Therapeutics, Inc. 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.