Theralase Technologies Inc. V.TLT

Alternate Symbol(s): V.TLT.W | 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. > TLD1433 vs Keytruda

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Comment by wildbird1on Nov 22, 2022 9:03am

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Post# 35118200

RE:RE:TLD1433 vs Keytruda

Good points Eoganacht & CancerSlayer...

In the link provided in your post, page 9, paragraph 2&3.

For hign-risk NMIBC that are unresponsive to BCG(TLT Patients). There are no currently approved standard therapies for patients in this clinical condition.

As for Radical Cystectomy(removal of the bladder) the FDA agree it is generally considered the standard of care for patients with BCG-Unresponsive high-risk NMIBC (TLT Patients), the FDA additionally agree that Radical Cystectomy (removal of the bladder) is a procedure with high rates of morbidity and mortality.

The above could explain why TLT will apply for BTD(Breakthrough Designation), as TLT treatment is badly needed.

CancerSlayer wrote:

Eoganacht wrote: On January 8, 2020, the FDA approved KEYTRUDA for the treatment of patients with (BCG)-unresponsive, high-risk, NMIBC. It is instructive to compare the CR results achieved by Keytruda and the likely CR results of the first 25 TLD1433 patients at 450 days (15 months) TLD1433 clearly offers a higher durable complete response rate. TLD1433 also offers a much better safety profile with Theralase contending that none of the serious adverse effects suffered by the patients were the direct result of the treatment.

Keytruda TLD1433

CR at any time 42% 50%

CR at 15 months 13% 32%

CR at 18 months 8% NA

See page 25: PEMBROLIZUMAB-P057V01MK3475 Advisory Committee Briefing Document

Thanks Eoganacht for that CR comparison....

Despite the pre-2018 urological workshops' recommendation for a 12 month CR benchmark of 30%, the FDA makes a strong point in that briefing document that those workshops were "not" advisory committee meetings....the FDA's recent approval of Keytruda, which had a 12 month CR rate of only 19%, clearly indicates (to our benefit) that the FDA has significantly relaxed the general stance on what defines a minimum CR threshold, which has a lot to do with the fact that this cancer indication has too few good treatment options.

Data is trending in the right direction, there are no significant safety concerns to date per TLT & the updated protocol is in place. As long as there continues to be strict adherence to the modified protocol across our trial sites, I'm seeing much more clear/smooth sailing ahead of us : )