Breaking News: The U.S. Food and Drug Administration (FDA) has accepted SciTech Development’s Investigational New Drug (IND) Application for ST-001 nanoFenretinide treatment of T-cell non-Hodgkin's lymphoma (NHL).
SCITECH at a glance
ST-001 nanoFenretinide (Proprietary Formulation)
= Fenretinide + SDV.
2 cancer indications: t-cell lymphoma; and,
small cell lung cancer (SCLC);
All diseases with limited therapeutic options.
Unique ST-001 nanoFenretinide Formulation
Drug delivery of therapeutic doses - safely & effectively.
Strategic & Rapid Drug Development
Existing human efficacy data;
Access to NCI data;
Streamlined clinical trials design;
Fenretinide provided free by NCI.
FDA expedited programs anticipated:
(1) Fast Track designation
(2) FDA Orphan Drug designation - Granted Dec. 2017
(3) Accelerated Approval pathway
(4) Priority Review designation.
Amount of Financing Sought
$15MM Series A for completion of clinical trials required for NDA filing.
Use of Funds
cGMP drug manufacture (ST-001) Clinical Trials (Phase I);
FDA compassionate use approval & NDA filings.
Time to Market
2-3 years (unusually short).
Drug Mechanism of Action (MOA)