Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

There will be a cohort 9 regardless of whether or not the dose escalates. If there was a DLT, then cohort 9 returns to the previous dosage of 165 mg/m2 and the number of participants expands to 6. If there was no DLT, then the next cohort will probably escalate ~35%, though it could be less. The next dosage would be 270 to 290 mg/m2. If a dlt appears in that cohort, then the 10th cohort would return to 215 mg/m2 which is well above the expected efficacy range.

Though some hope that the 9th cohort will be the last, IMO 10 cohorts will allow much greater latitude in designing the dose optimization protocol for K as a stand alone in a 2a/b trial, and a much higher safe starting dose for Phase 1b combination trials.

Either way, it looks like K Phase 1 won't wrap up until March or April 2015 at the earliest.