Allos Therapeutics, a biopharmaceutical company, has announced that the FDA has granted orphan drug designation to the company's novel antifolate, pralatrexate, for the treatment of patients with diffuse large B-cell lymphoma.
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Pralatrexate (PDX) is said to be a novel, small molecule chemotherapeutic agent that inhibits dihydrofolate reductase (DHFR), a folic acid (folate)-dependent enzyme involved in the building of nucleic acid, or DNA, and other processes. The company believes PDX has the potential to be delivered as a single agent or in combination therapy regimens.
Paul Berns, president and CEO of Allos, said: “We are pleased with this designation, which highlights the need for novel therapies to treat lymphoma.
“Pralatrexate previously received orphan drug designation from the FDA for the treatment of patients with T-cell lymphoma. This additional designation reinforces our intention to further evaluate pralatrexate as a potential treatment for patients with B-cell lymphoma.”
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