On February 1, 2018 SciTech Development reported that the U.S. Food & Drug Administration (FDA) has recently granted its lead drug product ST-001 Orphan Drug Status for the treatment of T-cell lymphoma (Press release, SciTech Development, FEB 1, 2018, View Source [SID1234523786]).

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SciTech’s lead drug product (ST-001) is comprised of the active pharmaceutical ingredient (API) fenretinide, a proven anti-cancer drug, and a specifically selected mixture of bioavailability enhancing phospholipids combined in a proprietary nano formulation. Fenretinide has previously demonstrated human efficacy in the treatment of neuroblastoma and leukemia as well as for lymphoma. ST-001 may be utilized as a standalone drug or in combination with other drugs and immunotherapy agents.

"The granting of orphan drug status by the FDA is a significant milestone in the development of our ST-001 drug program" said Earle Holsapple, President of SciTech Development. "We intend to make use of other FDA expedited programs including fast track designation, priority review and expedited new drug application (NDA) approval in bringing ST001 to market."

The FDA confers orphan status to drugs and biologics that treat rare diseases and disorders that affect fewer than 200,000 people in the United States. Benefits to companies receiving orphan drug status include tax credits and seven years of additional market exclusivity.