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Press Release

SciTech Oncology Drug Granted Orphan Status

SciTech Development,LLC
Posted on: 06 Feb 18
SciTech Oncology Drug Granted Orphan Status

SciTech’s Oncology Drug Granted Orphan Status

 

(GROSSE PONTE FARMS, MI) February 1, 2018 - SciTech Development is pleased to announce 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.

            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 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.

Information regarding SciTech’s nano formulation technology and oncology drug product ST-001 is available from SciTech Development, LLC by calling (313) 938-5517 or online at https://www.scitechdevelopment.com/ .

 

About SciTech Development

 

SciTech Development, LLC is a clinical stage oncology drug company currently bringing to market a proven cancer drug for diseases with otherwise limited therapeutic options. SciTech Development is headquartered in the Metropolitan Detroit Michigan Area with laboratories at the Sinai Hospital BioIncubator in Baltimore Maryland.

 

For More Information:   Earle T. Holsapple, President

                                           SciTech Development, LLC

                                           (313) 938-5517

For more information:
www.scitechdevelopment.com/news

Editor's Details

Lou Scarmoutzos
SciTech Development, LLC
www.scitechdevelopment.com
(617) 283-2182
lou@scitechdevelopment.com

Last updated on: 06/02/2018

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