RE:Patients 5 & 6 from Phase 1 We are in the realms of hypothesis JustforFun. We don`t know whether there will be future immune responses or if they occur whether they will be be full or partial although it is interesting that you completely write off the possibility of any immune response even with a second treatment when in reality much inferior photosensitisers in much cruder Trials have consistently produced immune responses and after only one treatment.The Company`s speculation of micro-metastases in the bone suggests that they themselves didn`t believe that P4`s recurrence came from the UUT.
You then imply that none of the improvements made in the long delay between Patients 4 and 5 - and these included a more powerful laser and crucially (with real-time feedback ) the development of a personalised treatment - would have made any difference to the outcomes for Patients 1 to 4. This again is something that we do not and cannot know but it was only after these improvements that the Company was able to state with confidence for P5 after 90 days` that there was ‘no tumour recurrence or presence of disease' and for Patient 6 with confidence as soon as the 60-day check-up that there was ‘no clinical evidence or presence of disease’. Note the slightly different wording between the two - this may reflect a view that P5 had had an elevated potential for recurrence.
Patient selection may well be being made with the benefit of lessons learnt in Phase IB and this is only fair. Other Trials have started ab initio with early-stage NMIBC and thus without the burden of addressing cancer that has escaped the bladder. Don`t have the percentages of patients who present with metastatic NMIBC as against those whose UUTC is a result of multiple failed bladder treatments but would guess that the latter make up a large %.So the very existence of a safe and effective PDT for early stage NMIBC will on its`own greatly reduce the numbers with cancer in the UUT and in time maybe obviate the need even for a preceding re-section.
So this is a hugely exciting and potentially game-changing Trial - particularly for Public Health in the context of the time and expense that must presently be devoted to this disease. Not saying that you`re necessarily a basher but you`re not allowing for anything to the upside from any of the unknowns here.