The original protocol for the trial specified 40 patients to be enrolled. Due to maximum tolerated dose ("MTD") not yet being identified and data indicating that the effect of Kevetrin on p53, a key tumor suppressor protein often referred to as the "Guardian of the Genome," is dose dependent as expected, Cellceutix requested an amendment to the protocol to continue to evaluate administration of Kevetrin at higher doses. The trial is currently in its eleventh cohort, with one patient (the 40th in the trial) having received two infusions of Kevetrin at 750 mg/m2. The Company has been advised that screening of additional patients is underway and they are expected to be enrolled into the study
Edit for correction: The ASCO poster presented May 30 said Cohort 11 (10 on the poster) was still ongoing. Shapiro stated that 2 of the 3 were still in the dosing cycle. So, as of end of May Cohort 11 had not yet finished. Just before that, the trial was expanded by 20 more patients without explanation of how those final 20 would enroll.