Theralase Technologies Inc. V.TLT

RE:RE:RE:RE:RE:huh?

[Rumpl3StiltSkin]

40% Sounds great @ 450days to me. 1-2 treatments. Repeatable. Standalone... I do think they will include the 3 Phase1 patients who were given the larger dose. They have been including them so far..??

Eoganacht wrote: Hi 99942Apophis - this chart is from the last MD&A (with the number of patients added)

"An analysis of Evaluable Patients (defined as patients who have been evaluated by the principal investigator and thus excludes data pending), in Study II provides the following interim analysis (including three patients from the Phase Ib NMIBC Clinical Study treated at the Therapeutic Dose):"

Assessment Days	450
Complete Response ("CR")	21%   (5 patients)
Partial Response("PR")	13%   (3 patients)
Total Responders (CR and PR)	33%   (8 patients)
Evaluable Patients	24

In my previous post I was forgetting that the 24 evaluable patients included 3 patients from the phase 1 trial. If we remove those phase 1 patients we have 21 patients from the phase 2 trial who have been evaluated at 450 days. So I think we are waiting on 4 patients to be evaluated not just 1. But we also have to subtract the 2 CR patients from the phase 1 trial. If all 4 patients are CR we will have a 28% CR rate for the first 25 phase 2 patients and if we can include the PR patients it will be a 40% CR rate.

Unless I made another mistake somewhere...

99942Apophis wrote: Hi Eoganacht patients 21-24 were announced August 30/2021 in receiving their primary treatment so they have only reached 360 days which would mean they along with patient 25 will then reach 450 by mid to end of December, if that's the case then the CR percent will be greater as those 5 represent 20% of the Phase2  population. My assumption here is when new patients are announced they have primary treatment but have not reached their 90 day target,  am I wrong?


Eoganacht wrote
In December we should see the submission of the 450 day results for the first 25 patients. We already know the results for the first 24. Currently the 450 day CR rate is 21%. If the 25th patient is CR this will be a CR rate of 24% And if the 3 PR patients are converted to CR this will be a CR rate of 36%.

These results, along with the better results of the patients who have not yet reached 450 days, the patient friendly 2 dose protocol and the high safety profile, should be enough for BTD and AA IMHO.

Keytruda was approved by the FDA for treatment of BCG-unresponsive NMIBC with only a 19% CR rate at 12 months, multiple treatments (every 3 weeks for up to 24 months) and 67% treatment related adverse events.

In contrast, the TLD1433 trial has only seen 19% of the 42 patients with serious adverse effects and Theralase believes that none of them are treatment related.

Scorpio2 wrote: We could get news on the vaccine front anytime in October.

But, the real biggie will be the Phase 2 ACT trial update anytime in December.