Theralase Technologies Inc. V.TLT

450 Day Assessment Results for the First 13 Phase 2 Patients

[Eoganacht]

These are available from the MD&A from November 29, 2021 on sedar:

"As of November 29, 2021, Study II has enrolled and provided the primary study treatment for 30 patients (including three patients from the Study treated at the Therapeutic Dose) for a total of 33 patients, providing the following interim results, with significant clinical data still pending:"

Here is the portion of the chart dedicated to the 450 day assessment.

Assessment Day	450 Days
	#	%
Complete Response ("CR")	4	12.10%
Partial Response ("PR")	2	6.10%
Pending	17	51.50%
No Response ("NR")	10	30.30%
Total Treated	33	100%

If we remove the 3 phase 1 patients (2 CRs and 1 NR) and the 17 pending patients who have not yet been assessed at 450 days we are left with a total of 13 patients. These 13 patients are comprised of the first 12 undertreated patients plus the first patient to receive only optimized treatments. A revised chart of just these 13 patients at 450 days looks like this:

Assessment Day	450 Days
	#	%
Complete Response ("CR")	2	15%
Partial Response ("PR")	2	15%
No Response ("NR")	9	69%
Total Treated	13	13

Assuming patient 13 was either a CR or a PR, 3 of the first 12 patients responded to the treatment - either 2 were CR and 1 was PR, or 1 was CR and 2 were PR at 450 days. 9 of the first 12 patient were NR (assuming patient 13 was not NR)

[Eoganacht]

These results make a lot of sense given the posts of enriquesuave and consultant99. The 8 out of 12 patients who did not receive an optimized treatment were all NR at 450 days. And 3 of the 4 patients who received only one optimized treatment were either CR or PR at 450 days. 

[consultant99]

I follow your math and logic. If we then look at the Nov 2022 data for patients @450 day excluding the three patients in the phase 1b trial I get the table below; note IR is equivalent to PR previously Complete Response         6    23.0% Indeterminate Response  3    11.6% No Response      

[enriquesuave]

I assume details will be explained as to IR patients and possibly 1st 12 undertreated patients to give more context.     Conclusions:  The interim data support that treatment with Photo Dynamic Therapy provides a viable treatment option for patients with BCG unresponsive CIS (+/- papillary disease) with an acceptable ongoing safety profile. Clinical trial information

[bigkagan]

They should use X-rays instead of laser. X-rays can reach everywhere, whereas laser beams are restricted where they can reach