PreScience Labs

IND Application

On January 11, 2013, the FDA informed PreScience that it may commence immediate enrollment of its Phase I clinical trial evaluating its lead drug candidate, PSL-001, delivered intra-arterially into the liver. Over many years of research, this drug has shown extraordinary efficacy in both multiple cancer cell lines and numerous animal tumor models. Preclinical studies in various tumor types have demonstrated that this potent drug is extremely effective and well-tolerated. These results have been reported in multiple published manuscripts and presented throughout the world at medical conferences. The planned Phase I study will evaluate the dosing regimen of the drug to determine the maximum tolerated dose (“MTD”). This will allow PreScience to prepare for the Phase II study which will specifically study drug efficacy.