Theralase Technologies Inc (TLTFF)

[Naamplao]

In an earlier post I showed a post from Stockhouse where the candidate inclusion/exclusion criteria were shown. It is quite definitive and clearly shows the difficulty in enrolling suitable candidates for the Phase 1 study.

My only caution back then was that the poster did not give a confirming link to where they got this information.... well I found such a link today.

https://clinicaltrials.gov/ct2/show/study/NCT03053635?term=tld-1433&rank=1

I found in the detailed description of the test a description of the doses to be used in the testing

https://clinicaltrials.gov/ct2/show/study/NCT03053635?term=tld-1433&rank=1&show_desc=Y#desc

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The study will consist of 2 phases. In the first phase, 3 subjects will receive PDT employing 0.35 mg/cm^2 (maximum recommended starting dose) TLD1433 and 90 J/cm^2 of green light delivered by TLC-3200. If treatment with the maximum recommended starting dose does not raise significant safety concerns as determined by the safety monitoring committee, an additional 6 subjects will receive PDT with 0.70 mg/cm^2 (therapeutic dose) TLD1433 and 90 J/cm^2 of green light delivered by TLC-3200.
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So yes, there will be a therapeutic dose but it will not be used on the first 3 patients... unless all is well with the initial starting dose. Even that second dose would probably be changed in a phase 2 trial where they would attempt to fine tune the therapeutic dose to get an optimum result.

Read this document and there should be no confusion as to what is being done in the testing for Phase1b

Efficacy data will be collected from the tests but it is third on the list of importance of outcomes. The document shows the primary outcome measure to be Safety, secondary outcome measure to be Pharmacokinetics and under "other measures" there is efficacy.