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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. > Of 41 patients CR @90-days, 88% demonstrated CR @180-days
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Post by ScienceFirst on Nov 28, 2022 10:40am

Of 41 patients CR @90-days, 88% demonstrated CR @180-days

This speaks bold.  This offers a new alternative to patients.  And that's what the FDA wants.


In the May 29, 2022 MD&A, we had this very interesting data focusing on all the patients and comparing them to the optimized group of patients:


For all 41 patients treated in Study II, who achieved a CR at 90 days, 88% demonstrate that CR at 180 days, 53% at 270 days, 29% at 360 and 450 days, respectively, demonstrating a strong duration of complete response.


For the first 20 patients treated in Study II, who achieved a CR at 90 days, 78% demonstrate that CR at 180 and 270 days, 56% at 360 and 450 days, respectively, demonstrating a strong duration of complete response.



It shows that back then, TLT had data for the 20 first patients, most probably because of a previous meeting with the FDA.  And in both cases (41 patients and first 20 patients), our treatment was offering a real altervative to patients by avoiding them a cystectomy.  And that's exactly what the FDA is looking for. 

Anything that can delay or even completely avoid the removal of the bladder will be given an accelerated approval and priority review, given how major is the removal of a bladder.  Why would the FDA delay such accelerated approval, given the low side effect of our treatment?  That's probably the kind of guidance that the FDA gave to TLT.

It's all about given patients new alternatives, so they can keep their bladder or delay such complicated surgery that is a cystectomy.

No doubt our treatment qualifies so far.



___________________________


RE:RE:N-803 had been granted Breakthrough designation. We will too

ScienceFirst great catch...(the best catch I have seen lately).

If we sum-up, for the FDA, the new goal for NMIBC patients(like TLT patients) would be Avoiding Cystectomy(removal of the bladder).
The above is one more proof as to why TLT has always included a TR%(CR+PR) line in their NewsRelease data.

PR Patients.
Partial response patients are patients that still have their cancer, but the tumor has gotten smaller(30-50%), and the tumor is not growing. If you are a PR patient, it does mean you can keep your bladder(avoid cystectomy), and take a break from treatment, as long as the tumor doesn't start to grow again.
For some patients, PR can last a lifetime( almost as good as a CR patients).
https://webmd.com/cancer/remission-what-does-it-mean

To sum-up, TR% is the number of patients that have achieved the FDA goal of Avoiding Cystectomy.

Let's see what could be the TR% for the optimized patients group.
From the 3Q2021 NewsLetter.
TLT has received the data on 11 optimized patients(18-7 pending=11 patients).
CR...............8/11............73%
PR...............2/11............18%
TR..............10/11............91%
NR................1/11..............9%
At 90 day, 91% of optimized patients have achieved the FDA goal of Avoiding Cystectomy.

Note; There is absolutely no way the FDA will waste time and energy on 12 undertreated patients that have received the wrong treatment protocol(it would be counterproductive).
No! The FDA will focus on the optimized treatment protocol that save lives and bladders.

And if at 450 day(Dec 22), the optimized patients group has achieved a very high TR%, you can bet your shirt that the FDA&TLT will have a serious talk about such a high number of optimized patients that have achieved the FDA goal of Avoiding Cystectomy.

The FDA may have no choice, but to give TLT, BTD and AA(Accelerated Approval) for commercialization as soon as possible(2023), to save more bladders and lives.


ScienceFirst wrote:It's impossible that TLT not be granted Breakthrough designation when you read carefully the news release of ImmunityBio's of Dec. 2019, as we clearly see the goal of the FDA:


Dec. 4, 2019:

ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in Non-Muscle Invasive Bladder Cancer


Results of Phase 1 and 2 studies in BCG Unresponsive Non-Muscle Invasive Bladder Cancer in High Risk Carcinoma in Situ Disease Earn FDA Breakthrough Status for ImmunityBio’s IL-15 Superagonist Complex

The FDA published guidance in February 2018 to address BCG unresponsive NMIBC, stating that the goal of therapy in patients with BCG-unresponsive NMIBC is to avoid cystectomy.


The Urgent, Unmet Need to Treat NMIBC and Avoid Cystectomy

Bladder cancer has a high incidence worldwide, with 199,922 deaths and an estimated 49,393 new cases in 2018. 2 In the United States, bladder cancer is the fourth most commonly diagnosed solid malignancy in men and the twelfth for women; The American Cancer Society estimates 80,470 new cases and 17,670 deaths in 2019. 3 Bladder cancers are described based on how far they have invaded into the wall of the bladder. NMIBC occurs when the cancer has not grown into the main muscle layer of the bladder.  Approximately 75-85% of all newly diagnosed cases of bladder cancer are non-muscle invasive bladder cancer (NMIBC).4

For the last 30 years, BCG immunotherapy has been the standard for treating NMIBC. However, disease recurrence and progression rates remain unacceptably high. Standard of care recommendations for these patients include lifetime invasive surveillance and rapid treatment of recurrences, creating a substantial financial burden and drastic impact on quality of life. Of those patients who experience recurrence, approximately 30% will progress and succumb to their disease over a 15-year period, and another 50% will undergo radical cystectomy of the bladder in an attempt to control their disease. 5

For high-risk NMIBC patients who are BCG-unresponsive with persistent or recurrent disease, treatment guidelines recommend a surgical procedure called radical cystectomy, a surgery to remove the entire bladder that may require removal of other surrounding organs. In men, removal of the prostate may be necessary, and in women, surgeons may also remove the uterus, fallopian tubes, ovaries and cervix, and occasionally a portion of the vagina. Despite the advent of minimally invasive procedures and robotic techniques, the 90-day mortality and morbidity rates in patients who undergo cystectomy remain unacceptably high at 5.1-8.1% and 28-64%, respectively. 6 Based on this urgent need, FDA published guidance in February 2018 to address BCG unresponsive NMIBC, stating that the goal of therapy in patients with BCG-unresponsive NMIBC is to avoid cystectomy.






__________________

 
Comment by Eoganacht on Nov 28, 2022 11:53am
It's amazing how many otherwise well informed articles about photodynamic therapy do not seem to realize that the perceived deficiencies of pdt have either been solved or are on the way to being solved. The problem of patient light sensitivity post procedure is gone. The problem of insufficient selectivity to cancer cells - which led to bladder damage in patients in the earlier photofrin NMIBC ...more  
Comment by CancerSlayer on Nov 29, 2022 2:43am
Eoganacht wrote: "It's amazing how many otherwise well informed articles about photodynamic therapy do not seem to realize that the perceived deficiencies of pdt have either been solved or are on the way to being solved. The problem of patient light sensitivity post procedure is gone. The problem of insufficient selectivity to cancer cells - which led to bladder damage in patients in ...more  
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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)
     
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