Replies to post #117888 on Innovation Pharmaceuticals Inc (IPIX)

[GregChase]

750 MG didn't start until late April 2015


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.

http://finance.yahoo.com/news/cellceutix-provides-corporate-140507963.html

[BonelessCat]

We don't know if the 11 cohort is done. The 3 original patients surely have finished, but I have seen nothing that states the cohort complete and cohort 12 started. CTIX received permission to expand the trial by up to 20 more patients. We don't know yet how the trial expansion is applied. It could be up to 20 more at 750 or it could be 3 more at an escalated dose for cohort 12 with a determination for the final 17, return to lower dose or expand 12 as the final cohort. They might even reduce the dosage to 450 which would expand cohort 10. This would be to reduce the chance of another DLT event so that all 20 patients could complete dosing cycles with out the complication of a possible DLT and forced application of MTD that would cause more delays for completing the trial. As far as cohort and dose is concerned, there are too many unknowns to effectively predict these final days of the Kevetrin Phase 1 trial.