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news.The FDA has granted orphan drug designation to Seattle Genetics for its treatment for acute myeloid leukemia and another drug used in the treatment of Hodgkin's disease.
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Seattle Genetics expects that SGN-33, the candidate for acute myeloid leukemia (AML) patients, will be advanced into two combination clinical trials during 2007. This will include a phase II study in combination with low dose chemotherapy for older patients with AML.
With the drug for Hodgkin's disease SGN-35, the company is conducting an ongoing phase I dose-escalation study with plans to report data in December 2007.
Orphan drug designation provides Seattle Genetics with seven years of marketing exclusivity, as well as the opportunity to obtain grant funding from the US government to defray costs of clinical trial expenses, tax credits for clinical research expenses and potential waiver of the FDA's application user fee.
The orphan drug act is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals in the US.