RE:RE:Theralase = TLD-1433enriquesuave wrote: Nice one Fred. Can they use multi wavelength PDT to address CIS within possible folds in the bladder and thus reduce possible under treatment further? I think that simply correcting the error of using maximum bladder volume both when instilling the drug and when irradiating with green light should solve the problems encountered. I thought they had already cleared that up in PH1, but at least they will correct after 7 patients as 5 will be retreated a 2nd time with optimization. It's a good thing that London and Nova Scotia didn't start treating I guess, they will at least use optimized method. We should not over expect, I think that if we hit 40% 12 months CR or better that we can still become the next Gold Standard as we would be above the 30% benchmark and way better than any competition as well as being the safest and least number of treatments. That would not get us Accelerated Approval but full approval after 100 patients IMO. I still believe that there is a 50-60% chance that we make it to Accelerated FDA approval after the next 12-15 patients are treated if the optimization does the job. If safety was met with flying colours then they should not be scared to slightly over treat or at least treat within the maximum limits of safety in order to achieve maximum efficacy. It will be another while, but we may see more data from these first 8 after they are treated a second time, or at 12 months? Unfortunately we need more patience.
fredgoodwinson wrote:
TLD-1433 is the super compound. As Quattro mentioned it has built-in safety with its` steep green light gradient and high selectivity for surface cancers and when pre-incubated to create Rutherrin can treat deeper and larger tumours whether through multi-wavelength PDT or X-Ray.
Phase II NMIBC is doubly disappointing as if correctly dosed these first 12 could have showcased TLD-1433 to the wider world. It is galling to think that cruder photosensitisers have been activated with less attempted precision at doses sufficient to kill NMIBC while the much safer and more cytotoxic TLD-1433 has not.
The long-term intellectual property ownership of this and the suite of potential metal-based photosensitisers that the Company took under license from Sherri IS Theralase but TLD-1433 in particular as it has IND status and a growing Clinical database.
The great advances made and being made by Dr.Lilge in developing safe and effective treatment strategies should not restrict the Company from looking to commercialise TLD-1433 on as wide a basis as possible. Full Monte is open source and as Lumeda show the DFOC not the only device. It is time for deals to be done.
Nice points Enrique,
I agree about TLT with 100 patients getting approval, since this is a pivotal study. I also agree about the ~40% being a good number to shoot for. I do think though that TLT might be able to better this and as you say get to Accelerated Approval. I'm betting a max of 60 patients treated between US/Canada is when we will get that BTD or AA. IF the % is somewhat better than 40.