MM Phase 1 trial, each patient received a single intralesional ("IL") injection of PV-10 into each of 1 to 20 target lesions.
In the MM Phase 2 trial, each patient received an initial IL injection into each of up to 20 target lesions. Additional injections ("repeat dosing") into treated lesions not exhibiting complete response were permitted at the discretion of the investigator at 3 time periods (week nos. 8, 12 and 16). Phase 2 trial results subsequently improved over the Phase 1 trial results.
In the contemplated MM Phase 3 trial, each patient would receive an initial IL injection of PV-10 into, presumably, any and all identifiable lesions. Additional injections then would be permitted into lesions every 2 weeks until disease control was achieved. The data and success of treating lesions more frequently with less or no constraints comes from Provectus' experience with patients in the company's compassionate use program, or CUP. As such, it is not unreasonable to think MM Phase 3 trial results, if the trial is undertaken at all, would improve over the Phase 2 trial results.