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SciTech’s Oncology Drug Granted Orphan

Friday, February 2, 2018   (0 Comments)
Posted by: Kate Oesterle
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(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/  and  .

 

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.

 

Forward-Looking Information

 

This press release and linked information contains forward-looking statements, including information about management's view of SciTech Development LLC (“the Company”), future expectations, plans and prospects. In particular, the words “believes,” “expects,” “intends,” “plans,” “anticipates,” or “may,” and similar conditional expressions are intended to identify forward-looking statements. Any statements made in this release and linked information other than those of historical fact, about an action, event or development, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors, which may cause the results of the Company, its subsidiaries and concepts to be materially different than those expressed or implied in such statements. Unknown or unpredictable factors also could have material adverse effects on the Company’s future results. The forward-looking statements included in this press release and linked information are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. Finally, the Company undertakes no obligation to update these statements after the date of this release, except as required by law, and also takes no obligation to update or correct information prepared by third parties that are not paid for by SciTech Development LLC.

 

For More Information:   Earle T. Holsapple, President

                                           SciTech Development, LLC

                                           (313) 938-5517

 

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