SciTech announced today that it has successfully manufactured the clinical supply of its lead drug candidate, ST-001 nanoFenretinide, to initiate its upcoming clinical trial in T-cell non-Hodgkin lymphomas (NCT04234048).
SciTech’s contract drug manufacturing partner has successfully manufactured ST-001 under strict QA/QC quality standards. Through a combination of innovative science and advanced nanotechnology, SciTech has developed ST-001, a new and patented formulation that enables the safe and rapid infusion of high-dose fenretinide for cancer treatment. SciTech’s Delivery Platform maximizes the bioavailability of water-insoluble drugs. ST-001 has passed extensive testing required for IV-administered drug products, including United States Pharmacopeia (USP) testing for sterility, endotoxins, particle sizing, and particulate matter as well as International Conference on Harmonization (ICH) guidelines for heavy metals and drug impurities.
“SciTech is thrilled to announce the successful manufacturing of ST-001 as we begin our human clinical trials. This is another major milestone for the company. Our team and investors are passionate about bringing ST-001 to the market for the treatment of T-cell lymphomas and other broader indications,” said Earle Holsapple, President of SciTech Development. “We know that both patients and clinicians are looking for innovative and cost-effective ways to solve this cancer epidemic. SciTech is proud to be part of the medical community offering a new therapeutic and a giant step forward to help conquer cancer.”
SciTech’s specialized drug formulation increases the bioavailability of fenretinide, which allows more of the active drug to reach the cancer cells. ST-001 binds to the cancer cells and disrupts the nucleus, causing the cancer cells to die. With ST-001, our goal is to reduce drug-related toxicities and achieve optimal drug concentrations for better patient outcomes.