Lead cancer drug candidate, ST-001 nanoFenretinide, has received Institutional Review Board ("IRB") approval for its upcoming clinical trials for T-Cell Lymphomas.
GROSSE POINTE FARMS, MI / ACCESSWIRE / September 14, 2023 / SciTech Development ("SciTech" or the "Company"), a clinical-stage pharmaceutical company with a novel and patented drug delivery platform, today announced that the company has received IRB approval for its clinical trial protocol for their lead cancer drug candidate, ST-001 nanoFenretinide.
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SciTech is pleased to announce that it has received central IRB approval from WCG to enter the clinic at the University of Pittsburgh Medical Center. USC Keck Medicine also granted SciTech local IRB approval to enter the clinic. Additional clinical sites will be added as the trials expand. ST-001 has FDA Investigational New Drug (IND) approval, orphan drug designation, and is Phase 1 clinical trial ready.
An Institutional Review Board (IRB) is an FDA-registered consortium that has been formally designated to review and monitor biomedical research involving human subjects. IRB approval is a critical and necessary prerequisite to commencing human clinical trials and serves an important role in the protection of the rights and welfare of human research subjects. WCG is the world's largest independent centralized Institutional Review Board with over 200 IRB experts, servicing more than 800 institutions, with hundreds of active sites around the world.
"The IRB approval of our accelerated T-Cell Lymphoma trial protocol is an important step that allows us to move forward with recruitment for our Phase 1 clinical trial," commented Earle Holsapple, SciTech's President and CEO. "We are excited to initiate this important study as there have been relatively few new cancer breakthroughs for T-Cell Lymphomas in several years."
About SciTech Development
SciTech Development, LLC is a clinical-stage pharmaceutical company that has developed a patented nanoparticle drug delivery platform (SDP) that maximizes the bioavailability of water-insoluble therapeutics. SciTech's lead drug candidate, ST-001 nanoFenretinide, combines SDP and the drug fenretinide as a broadly applicable anticancer drug.
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SOURCE: SciTech Development