The FDA has completed the review of the company’s investigational new drug application for Kevetrin.
The Phase 1 trials were scheduled to be conducted at Harvard Cancer Center’s Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center.
The Institutional Review Board and the Scientific Review Committee at the hospital notified the company regarding the approval of the study protocol.
According to the company, Kevetrin has significant potential to be a major breakthrough in the treatment of solid tumors.
Kevetrin demonstrated its ability to affect both wild and mutant types of p53 and strongly induced apoptosis (cell death), characterized by activation of Caspase 3 and cleavage of PARP, in the mechanism of action studies.