Innovation Pharmaceuticals Inc (IPIX)

[TOB]

Here is a slide showing the standard 3 + 3 Phase I Clinical Trial design.

So in the study below the cohort is 3 patients, and another 3 are only enrolled if only 1 of the 3 patients in the cohort shows Dose Limiting Toxicities (DLT) at which point another 3 patients are enrolled at that dose level to confirm that that will be the Maximum Administered Dose (MAD). If 2 or more of the 6 show DTL then it is the MAD.

Otherwise the next cohort of 3 patients can be approved to move to the higher dose level.

Once the Maximum Administered Dose (MAD) is determined with either 3 or 6 patients, they can then run further dosing at the lower dose to confirm it is the Maximum Tolerated Dose (MTD).

For the Kevetrin study it is:

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.