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news.The FDA has awarded orphan drug designation to Allos Therapeutics' PDX, a novel next-generation antifolate for the treatment of patients with T-cell lymphoma.
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The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. In addition to potential market exclusivity, orphan drug designation will provide Allos with benefits such as potential protocol assistance, advice on the conduct of clinical trials with PDX (pralatrexate), and tax credits.
“This designation underscores the acute need for new therapies to treat T-cell lymphoma and provides Allos with potential market exclusivity and other benefits to support the development of PDX in this important clinical setting,” said Paul Berns, president and CEO of Allos.
Allos currently plans to initiate a phase II study of PDX in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) in Q3 2006.
Interim results from an ongoing phase I/II study of PDX in patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and Hodgkin’s disease have demonstrated preliminary evidence of activity in patients with various subtypes of aggressive and chemotherapy resistant T-cell lymphoma.
As reported previously, four of seven evaluable patients with T-cell lymphoma achieved a complete response following treatment with PDX, despite having failed multiple prior chemotherapies.