Theralase Technologies Inc. V.TLT

Alternate Symbol(s): V.TLT.WT | 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. > Excel spreadsheet display of new data from MDA

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Comment by NotinKansason Apr 27, 2023 1:21pm

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Post# 35417415

RE:Excel spreadsheet display of new data from MDA

Thanks DJDawg, great job. I just finished going through the numbers myself. Here's what I got from that:

The data presented (for a welcome change) is internally consistent: all #s and %s presented in the tables can be derived from the swimmers’ plot (use the verticals to arrive at the CR/IR numbers and rates presented in the tables).
The reduction in evaluable patients imo results not from exclusion of the undertreated cohort, but from the team having adopted a new calculation method. It looks as if they stop evaluating patients if there is no longer a point in doing so. The arrows in the plot indicate the patients for which further treatment/assessment/analysis still makes sense, the others, I believe, are considered ‘done’ and have/will receive(d) no further treatment/assessment beyond the last time points shown. Previously, such patients continued to count as ‘evaluated’ (most of them NRs) until 450 days, currently no more. It results in much higher CR/IR/TR rates at the later evaluation points. Confusing (compared to earlier reports): yes; misleading: I don’t know. I presume there will be protocols prescribing how the achievement of the trial objectives should be calculated. I guess/hope what we are seeing here is the impact of the biostatistics/regulatory organization they have hired for the job.
Albeit more difficult, it is still possible to make a bit of a comparison with previously reported data. CR numbers in NOV22 were 21 at 90 days, 15 at 180 days, 13 at 270 days, 8 at 360 days and 6 at 450 days (excl. Phase Ib). Now they stand at respectively 28, 23, 15, 9 and 8. Using the old way of calculating the CR rate at 450 days, we arrive at ~26% (8 out of ~31 evaluable patients, which was the number of evaluable patients at 360 days in NOV22, who all should have had their 450 days assessment now), up from 23% in NOV22 (all excl. Phase Ib).
Since NOV22 12 new patients have become evaluable at 90 days. Seven (58%) came out CR, and five NR.
Since NOV22 six new patients have been enrolled in the trial (not as many as during SEPT-NOV22).
From the swimmers’ plot it can be derived that a patient who achieves CR at 90 days has a ~63% chance of remaining CR until 450 days (which would translate into a 34% CR rate at 450 days using the old formula).
The swimmers’ plot also suggests that, sadly, the maintenance treatment at 180 days does little to improve the odds for those who enter that treatment IR or NR.

GLA.