The protocol safety committee met on April 13, 2015 to review data for patients treated in the 450 mg/m2 cohort and recommended that the next cohort receive Kevetrin doses of 750 mg/m2 (a 67% increase in dose and 75x the initial dose).
The current protocol was originally designed to evaluate 40 patients. 39 patients have been treated to date, meaning that one patient will receive the 750 mg/m2 to complete enrollment per the original trial design. Because of the stepwise increases in Kevetrin dose that have occurred, and the fact that a maximum tolerated dose has not been identified, Cellceutix has requested amendment of the protocol to allow treatment of additional patients at higher doses of Kevetrin. The Company has been advised that this request has been scheduled for the next Institutional Review Board meeting in late April or early May.