Ariad Pharmaceuticals Inc fka ARIA

[biomaven0]

Would they have to do another trial on front line patients if they wanted to use a lower dose?

They are certainly not required to do so. If time was no object you would run another Phase II in this population to determine the optimal dose, but I can't believe they would even consider doing that for a moment.

Perhaps they could get away with a flexible dosage regimen - start at 30mg (or even lower) and up the dose if there is inadequate response. The FDA might grumble a bit, but likely they could get away with it. Alternatively they could run a couple of dosage groups in the pivotal trial.

It's worth noting that a few resistant patients had a good response at 5mg in the Phase I, so quite likely there is room for a dose reduction from 45mg in the frontline population. Tolerability is of course key to wide use, so I am sure they will be focused on using the lowest dose that is feasible.

Peter