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Destroying Cancer at the Speed of Light®

Clinical Study Underway (75 of 100 Patients Treated)
Expected to complete enrollment in 2025
Expected to complete study at the end of 2026


Bullboard - Investor Discussion Forum Theralase Technologies Inc. V.TLT

Alternate Symbol(s):  TLTFF

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... see more

TSXV:TLT - Post Discussion

Theralase Technologies Inc. > BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinom
View:
Post by Oden6570 on Dec 23, 2024 10:21am

BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinom

A xmas message from Theralase 



RuvidarTM

Theralase (TSXV:TLT), a clinical-stage pharmaceutical company dedicated to the research and development of light-activated small molecules, is developing a new drug for BCG-Unresponsive NMIBC CIS.

The company’s lead compound, the ruthenium-based molecule TLD-1433 (RuvidarTM), combines with an endogenous (naturally occurring) human glycoprotein in the body, known as transferrin, to become the patented drug, Rutherrin®, a light-activated drug that has demonstrated an ability to kill bladder cancer cells in a pre-clinical setting with over 99.9% effectiveness.

With an FDA new drug application submission planned in 2026 and potential FDA approval in early 2027, RuvidarTM has strong clinical data, achieving an initial CR of 61.9% and a duration of CR of 43.6% at one year, based on clinical data collected to date. Analyzing the KM Curve estimates, RuvidarTM demonstrated a duration of CR of 53% at one year, 35.8% at two years and 24.9% at three years in its latest phase-II results evaluating 63 patients.

What sets RuvidarTM apart from currently approved drugs and those vying for regulatory approval is its ability to completely destroy bladder cancer in 68.3% of patients (over 2 out of 3) after only one three-hour treatment. This provides a clear advantage to both the patient, who needs to attend each appointment, and the uro-oncologist or medical oncologist who needs to supervise each treatment.

Unlike a few of the drugs discussed here today, urologists can prescribe RuvidarTM across the entire BCG-Unresponsive NMIBC CIS patient population, without screening for the absence of various proteins for fear of a lack of effectiveness. In addition, RuvidarTM is used as a monotherapy (by itself) and does not need to be combined with other drugs to increase its efficacy or duration of response.

Supporting its high safety profile, the company believes that all serious adverse events in the clinical study have been unrelated to RuvidarTM or its proprietary TLC-3200 medical laser activation system.

These benefits have all eyes on Theralase®‘s ongoing phase-II clinical study, which has enrolled 75 patients to date and is on track to complete enrollment in 2025 through the recent launch of additional clinical study sites in Canada and the U.S.

The FDA awarded Theralase® the Fast-Track Designation in 2020, granting the company early and frequent communication with the federal agency. The company expects to complete patient follow-ups in 2026, with FDA and Health Canada regulatory approvals expected in early 2027.

In summary, if you are a patient or know someone diagnosed with BCG-Unresponsive NMIBC CIS, bladder removal is now not the only option on the table, as the latest approved drugs and those in clinical development have steadily increased the duration of CR over the past five years.

Talk to your uro-oncologist about how the drugs we’ve discussed in this article may be applicable to your particular cancer journey.

This is sponsored content issued on behalf of Theralase® Technologies Inc., please see full disclaimer here.
BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma-In-Situ: A Patient's Guide | 2024-12-23 | Investing News | Stockhouse

Comment by Legit62 on Dec 23, 2024 10:55am
Very interesting, no message of BTD, what the heck is up with that??? Did the FDA throw us under the bus?? Or is Theralase not saying anything at this point in time???? Was hoping we had news shortly
Comment by rollthedice10 on Dec 23, 2024 11:34am
I'm hoping they are saving some news for new year when people aren't distracted and stressed out as can be the case Christmas week. Also markets will be back open full time. Although I am new to TLT I can see that nothing is quick, not that I expected that. Dealing with Government agencies is never ever quick and can be downright frustrating. But I believe the rewards will be HUGE and ...more  
Comment by chry200030 on Dec 23, 2024 11:50am
I concur.. !!!
Comment by Maxcitrac on Dec 23, 2024 12:11pm
Legit62, Theralase not saying anything about BTD, could be interpreted as a positive sign for BTD approval in 2025. The reason being, when Theralase will announce BTD appoval in 2025, Theralase could have to do a Trading Stop, because of the possibility of a big increase in the SP value. At this point in time,Theralase can't take any chance of releasing any news about the BTD situation that ...more  
Comment by bmk211 on Dec 23, 2024 12:49pm
I thought per the zoom call they were submitting a pre btd.  It's not pass or fail for that probably no news to give regarding a pre btd.  The BTD they said would be submitted early 2025 I thought.
Comment by N0taP00p on Dec 23, 2024 1:25pm
Yes, a pre-BTD meeting late December followed by BTD submission in Q1 is what it sounded like.  Will know soon enough if the story has changed again. You would think the FDA has all the info it needs by now, especially given the FTD status since 2020. But we've been here before. 
Comment by Oilminerdeluxe on Dec 23, 2024 3:51pm
Pre- BTD meeting was scheduled for late Dec or Jan if memory recalls correctly. Hopefully, no change to that. Not that anything ever gets delayed. I know MP is looking forward to 2025, whatever that means. Merry Christmas all
Comment by Oilminerdeluxe on Dec 23, 2024 4:50pm
Planned to be scheduled, it should have said. A slight difference.
Comment by Alamir1111 on Dec 23, 2024 5:17pm
Cmon ceo wake up https://www.fiercebiotech.com/biotech/phase-2-data-will-drive-biopharma-vc-investments-next-year-pitchbook
Comment by bmk211 on Dec 23, 2024 5:32pm
From what i understand, there isn't any news to report on from a pre-BTD.    It's not a pass or fail.  Anything said would be speculation or misleading i assume.  
Comment by enriquesuave on Dec 23, 2024 7:58pm
That promotional message seemed to be addressed more potential patients rather than to investors. 
Comment by tdon1229 on Dec 23, 2024 8:35pm
Very little gets done in D.C from mid-December to mid-January
Comment by toade1313 on Dec 23, 2024 8:38pm
Very little positive things got done in last 4 years in DC.
Comment by Habeneropie on Dec 23, 2024 11:07pm
Well........ very many cataclysmic things are coming next four years!!!!
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The Road to Saving Lives: Clinical Study Underway

  • Clinical Study with 75 of 100 Patients Treated (Enrollment to be completed in 2025, with study completed by end of 2026)
     
  • Ground Floor Investment Opportunity in Multi-Billion Dollar Industry
     
  • Best-in-class treatment for NMIBC (according to interim clinical data)
     
  • NMIBC (Non-Muscle-Invasive Bladder Cancer)
     

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Address:
41 Hollinger Road
Toronto, ON M4B 3G4
Canada

Toll Free:
1-866-THE-LASE (843-5273)
Local Phone:
416-699-LASE (5273)

Email:
info@theralase.com

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416-699-5250