The U.S. Food & Drug Administration (FDA) has granted SciTech Development’s ST-001 orphan drug status for the treatment of T-cell lymphoma.
ST-001, the company’s lead drug product, 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 ST-001 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.
SciTech Development LLC, a clinical stage oncology drug company, is headquartered in the Metropolitan Detroit area with laboratories at the Sinai Hospital BioIncubator in Baltimore.
(Source: SciTech Deavelopment LLC)
Filed Under: Drug Discovery