Innovation Pharmaceuticals Inc (IPIX)

[TOB]

No, that is an incorrect interpretation. That refers to the number of patients in a cohort, not the dosing cycles.

i took this to mean 3 people on 3 doses per cycle. -goverchin

If it was said that "this is a standard 3 x 3 design" which is called 3 + 3, then that means a cohort is only 3 patients. It doesn't refer to the number of doses, rather the number in a cohort.

If no dose limiting toxicities (DLT) are observed, 0 of the 3 in that cohort, then the next cohort of 3 can move to the next dosing level. If exactly 1 patient shows DLT, then an additional 3 patients are treated at that current dose to see if the prior dose is the MTD and that dose will be the maximum administered dose. Otherwise the prior dose is the tentative MTD.

A tentative MTD becomes final when a total of 6 patients are treated at that level with less than 2 showing DLT, after the maximum administered dose has been determined by enrolling a second cohort of 3 and having 1 or more experience DLT.

The principal aim of an Oncology phase 1 trial is the identification of the Maximum Tolerated Dose (MTD). The majority of oncology phase 1 trials are run using a design called “3+3. Under this design, subjects are treated in cohorts of 3, and based on the number of dose limiting toxicities seen in that cohort, decisions on which dose to give the next cohort and whether to stop the trial are made. Oncology phase 1: CRM vs 3+3

Phase I Clinical Trial Design

A dose will be declared the MTD if at least 1 patient out of 6 patients experience a dose limiting toxicity (DLT) at the highest dose level below the maximally administered dose. Once an MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level for confirmation of safety.

The maximally administered dose is if 1 or more of 6 patients experience a DLT. Kevetrin trial outline

So they are using the standard cohort groups of 3, and as there were no reports of toxicity in the first cohort, another 3 were not enrolled at that dose and instead the next cohort of 3 were approved for the next planned dose escalation.

This would indicate we now have 6 patients total in dosing, 3 in cohort #1 and 3 in cohort #2.