Replies to post #14689 on Innovation Pharmaceuticals Inc (IPIX)

[magicatlast]

"If that were to happen, what would happen to tumor sizing in Cohort 1 if they had been dosed at different levels in different time frames?"

What an excellent and intellegent question!! Goes to the optimum doesage issue. I can see where the cohort 1 folks would want the higher dosage. Guess maybe the optimum dosage question might have to wait for later testing stages??

Magic

[BonelessCat]

what would happen to tumor sizing in Cohort 1 if they had been dosed at different levels in different time frames?

Nothing. It doesn't change anything about the tumor sizing, other than I would pray that each escalated dose would show increased reduction up to the optimal dose. Each cohort has the right to continue at the next dose level upon completion of the succeeding cohort and confirmation of safety.

So, if the second cohort demonstrates safety and no signs of dose limit toxicity, then cohort 1 can receive approval to continue with double the dose, and cohort 2 can continue with their current dose level. It's all up to the IRB and Safety committee.

The protocol is specifically written to prevent the trial host from denying a cohort continued treatment because it might skew the tumor readings and data at 2 months, 4 months and 6 months. As immoral and unethical as that may sound, that decision has been made in the past.