SciTech Development Announces IRB Approval for Human Clinical Trials
GROSSE POINTE FARMS, Mich., September 14, 2023 (Newswire.com) - 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.
For more information about the Company, please visit: https://SciTechSDP.com
Safe Harbor - Forward-Looking Statement: This document contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding attempts to identify new products, services or strategic opportunities which may include a strategic transaction, plans regarding partnering activities, service pricing or financial forecasts. Such statements are only predictions, and the Company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that the Company may not be able to identify acceptable strategic opportunities or conclude any identified strategic transaction, the risk that products or services that appeared promising in early use do not demonstrate the same utility in larger-scale uses or trials, the risks associated with the Company's reliance on outside financing to meet its capital requirements, and the risks associated with the Company's reliance on forward-looking contracts. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted, or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underly the forward-looking statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, political, environmental, competitive, and/or other material risks.
Source: SciTech Development
