Rayzzer wrote: goregil wrote: The markets response to the cancer returning after 90 days tells us the market is not impressed so far with phase 1 .In this case the market could be completely wrong I really hope so because Iam long Tlt. The market rightly or wrongly is looking for more proof that our treatment works.we did get unexpected good results at least for90 days.
If that is what the market believes then I think it is wrong. The study is progressing as needed to move on to a Phase 2. (I'm sure we all would like things to have progressed quicker)
bionicjoe wrote: Conclusion: (not Discussion)
3) An ability to delay recurrence and progression of NMIBC at the MRSD for between 90 to 180 days post treatment for patients, who have a clinical history or are at high risk of UUTUC and potentially longer for those that do not;
This is great to point out because it lays the ground work for a promising Phase 2 study. My guess is that exploratory efficacy was part of the Phase 1b so that it would help those designing the Phase 2 to determine what the monitoring and treatment schedule would be along with which dose to give. It’s not like multiple treatments was on afterthought.
We know that Dr. Mandel was already thinking about multiple treatments before seeing the results from 180 days. In the July 27
th NR he stated
“ Since the PDT procedure has been well tolerated and patients are able to undergo a repeat of the procedure, if required, this PDT treatment offers considerable therapeutic advantages.” I thought the NR on Nov 8
th did a good job explaining that the
lack of efficacy at 180 days was not putting a Phase 2 study in jeopardy. Or that this procedure is any less promising than it was after the 90 days results. I guess others didn’t think the same.
The Nov 8
th NR stated:
Enrollment and treatment of the remaining five patients to be treated at the Therapeutic Dose will provide additional data on the ability to achieve the primary, secondary and exploratory outcome measures at this dose and if so, up to which timepoint…. (Dr. Mandel stated)
If patients five through nine achieve the primary, secondary and exploratory efficacy outcome measures at 90 days post treatment, even if they recur at 180 days post treatment, but do not progress, then a strong argument can be made to schedule them for repeat PDT treatment procedures….
Dr. Mandel went on to say, “Using this initial data, in combination with the data to be obtained on the next five patients, the design of a Phase 2 clinical study, currently under review by the Company, would involve treating patients at either the MRSD, Therapeutic Dose or another dose, dependent upon: a review of the complete set of data achieved for all nine patients evaluated for the primary, secondary and exploratory outcome measures, the patient’s quarterly cystoscopy analysis and the detection or absence of recurrence, during this evaluation. Review of this dataset should allow for determination of the optimal dose for initial or additional PDT treatments, as required. Upon completion of the Study, Theralase will discuss the complete dataset with its Medical and Scientific Advisory Board (“MSAB”) to determine which dose of TLD-1433 would be most appropriate to use in a Phase 2 NMIBC multicenter clinical study.” Maybe this NR should have also mentioned the immune response as it did in the Nov 20
th NR about developing a study for GMB:
“receive repeat PDT treatments to induce an immune-mediated response.” And for those that were concerned if the company had enough TLD-1433 on hand to supply a multiple treatment Phase 2 study, the Nov 21
st NR had this to say:
“The confirmation of 24 months long term stability of the second clinical batch of TLD-1433 ensures that sufficient amount of the PDC will be available at Good Manufacturing Practice (“GMP”) levels for multiple Photo Dynamic Therapy (“PDT”) patient treatments during the planned Phase 2 clinical study for Non-Muscle Invasive Bladder Cancer (“NMIBC”).”