Theralase Technologies Inc. V.TLT

Alternate Symbol(s): TLTFF

Healthcare Medical Devices

Theralase Technologies Inc. is a Canada-based clinical-stage pharmaceutical company. The Company is engaged in the research and development of light activated compounds and their associated drug formulations. The Company operates through two divisions: Anti-Cancer Therapy (ACT) and Cool Laser Therapy (CLT). The Anti-Cancer Therapy division develops patented, and patent pending drugs, called Photo Dynamic Compounds (PDCs) and activates them with patent pending laser technology to destroy specifically targeted cancers, bacteria and viruses. The CLT division is responsible for the Company’s medical laser business. The Cool Laser Therapy division designs, develops, manufactures and markets super-pulsed laser technology indicated for the healing of chronic knee pain. The technology has been used off-label for healing numerous nerve, muscle and joint conditions. The Company develops products both internally and using the assistance of specialist external resources.

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Theralase Technologies Inc. > Patients who remained in Study 2

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Comment by Eoganachton May 03, 2023 8:19pm

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Post# 35428940

RE:RE:RE:RE:Patients who remained in Study 2

I very much hope yours is the correct interpretation Enrique. If it is we could be looking at that 50% - 60% complete durable response.

enriquesuave wrote:
wildbird1 wrote:
Eoganacht wrote: The phrase "...patients who remained in Study II" is ambiguous. It could be referring to the exclusion of the first 12 undertreated patients or it could also mean that the patients who developed high grade NMIBC are no longer being evaluated at later time periods. It would certainly be to our advantage if the first is meant and the FDA is allowing the 12 undertreated patients to be excluded. I hope Theralase is willing to offer clarification.

enriquesuave wrote: This quote seems to indicate that most probably initial12 not counted after 90 days. They started off in trial, ( hence included initially then dropped) and since were undertreated are now dropped after 90 days. IMHO

"The interim clinical data demonstrates a 90 days CR of 54% (n=52) and a sustained duration of response at 450 days of 67% (n=12), for patients who remained in Study II.
Note: To be included in the statistical clinical analysis a patient must be enrolled in Study II, provided the primary Study Treatment

and evaluated by a Principal Investigator (“PI”) at the 90 day assessment visit (cystoscopy and urine cytology)"
We will eventually get more details, but this must be in line with Statistician they are working with and FDA. Haven't yet called company.

Eoganacht..."patients who remain" could simply refer to the fact that some patients have been removed from study11, as stipulated in the 2Q2020 Newsletter, were TLT said 4/12 undertreated patients were removed from study11.

Yes Eoganacht. I would think that even NR patients with progression would be counted as evaluable, and as NR. It clearly states 8 out of 12 evaluable patients are CR, 2 IR and 2 NR. With more clarification this will be made clear.