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. > End Points

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Comment by CancerSlayeron Dec 21, 2020 9:45am

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Post# 32151759

RE:End Points

enriquesuave wrote: The Primary end point is CR at any time point. The Secondary endpoint is duration of CR status which is how long patient remains CR up to 365 days after CR was first determined. Tertiary endpoint of safety or adverse events. IMO most patients who are CR should be determined at day 30 or 90 depending on whether they do a cystoscope exam at 30 days as well as 90 days as well as urine cytology. It would seem that any patient who is determined to be CR at 30 days, then that would probably be the result of a complete tumor destruction. Anyone who would maybe be CR at 90 but not at 30 days would maybe be complete destruction only after development of an immune response after partial tumor destruction by PDT. All imo. I'm pretty sure they are doing cystoscope exams at day 30 as well. 2021 could and hopefully will be our best year ever to date. All imo

Hi Enrique... Assessments regarding safety & efficacy are supposed to be performed at multiple points in time, including on day 30 (barring any Covid-19 interruptions). They provide a more detailed description of their plan on clinical trials.gov as noted below.

Overall Study Design and Plan: Description

This is a phase II, open-label, single-arm, multi-center Study conducted in Canada, the United States and internationally. Patients with NMIBC CIS with or without resected papillary disease (Ta, T1) that are considered BCG-Unresponsive or are intolerant to BCG therapy that meet the inclusion and exclusion criteria will be enrolled and treated. The Study will consist of 100 patients who will receive PDT employing 0. 70 mg/cm^2 (Therapeutic Dose).
Screening Period

Patients will be qualified for Study entry by review of inclusion and exclusion criteria during the Screening Period, which will last up to 28 days.
Follow-Up Phase

All patients enrolled and treated by the treatment procedure will be followed until the End of Study defined as completion of all required assessments after 12 months of follow-up post treatment or earlier due to early discontinuation or withdrawal of informed consent.

During the Follow-Up Phase, information on efficacy and safety will be collected. Assessments will be conducted at Day 0, 7, 30, 60, 90, 180, 187, 210, 240, 270 and 360.