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Destroying Cancer at the Speed of Light®

Clinical Study Underway (68 of 100 Patients Treated)
Expected to complete enrollment at the end of 2024
Expected to complete study at the end of 2026


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

Alternate Symbol(s):  V.TLT.WT | 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. > About the addition of up to 9 CSS ...
View:
Post by ScienceFirst on Mar 14, 2023 9:11pm

About the addition of up to 9 CSS ...

It's not sure, but it's more and more plausible that this objective could be linked to a conditional Accelerated Approval, to act as a confirmatory trial. Especially that we have a holy grail oncology  treatment.

We know that the FDA requires that such confirmatory trial be already active, but is not dogmatic for smaller biotechs as per a recent article on the subject, considering the burden of such request.  So maybe they are being comprenhensible and flexible enough about when could these CSS be added and if these CSS could qualify as a confirmatory trial.

With our actual 12 CSS, we're treating on avg. 1 patient/month, globally.  COVID-19 clearly didn't help.(as it prevented us to enroll for 18 months).  A Breakthrough Therapy designation could certainly create more demand for our 12 CSS.  So having a higher avg/month (lets assume 2/month) would allow us finish our current trial faster.. 

Being at least at 51 patients (lets assume 54 as of today now) so far, 50% into a pivotal Ph. 2, and already having claimed that, late 2025/mid-2026, TLT could receive full FDA approval, I don't think these "up to 9 new sites" would make much of a difference in reaching that "2026" commercial rights as you have to remove almost 18-20 months to that "mid-2026" full approval (450 days since the last treated patient + 6 months of FDA evaluation/decision). So assume that our 100th patient would be treated late 2024.  With 12 CSS that would treat 2 patients/months, for 18 months (April 2023 to Dec. 2024), we could already add 36 new patients (12 CSS  x 2/months x 1.5 years).  36 + 54 = 90.  So without adding any new CSS, we could already be close to 100 patients by end of 2024.

These "up to 9 new sites" could also be because the FDA wants 125 patients, instead of only 100, considering the 12 undertreated patients, in order to have a better picture.  But even there, even with these 12 undertreated patients, we already have excellent numbers (28% CR and 38% TR), despite them representing 41% of our 29 evaluable patients (12 NR out of 29 evaluable patients).

So that leaves us with another potential purpose for such "up to 9 new sites" and that could be because of an obligation that comes from the Accelerated Approval program that requires a confirmatory approval trial, considering that we will have higher CR and DR the more we add optimized patients and that we would really qualifiy even more for Accelerated Approval program. 

We also clearly fit the spirit of the FrontRunner program (bringing late-stage treatment to early stage patients).  That would instantly jeopardize the BCG dominance.

We'll soon find out.  And it all depends on what the FDA has in mind regarding our trial (12 undertreated patients) and treatment (only up to 2 treatments, durable response, no serious adverse events (SAE) related to the treatment itself, higher efficacy than competition and higher reliability than BCG, no dependence with BCG).

We really have the holy grail key attributes of an oncology treatment:

- low number of treatments (1-2)
- high CR%
- high DR%
- high safety profile (no SAE)
- high efficacy
- standalone treatment
- no BCG dependent
- no patient discrimination (unlike immunotheapy treatments)
- no patient limitations (unlike gene therapy)
- low cost therapy, given low number of treatments, no combo and no SAE (Keytruda costs 455K$ for 2y)

Feb. 23, 2023:

Arkady Mandel MD, Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer, Theralase® stated, “The high complete response rates and duration of this complete response without serious adverse events, directly related to the study drug or study device, indicates that intravesical Ruvidar™ is a promising alternative to existing therapies and compares favorably to other approved therapies; including: valrubicin, pembrolizumab and Adstiladrin®.Ruvidar™, as an intravesical monotherapy, has the potential to be introduced into mainstream medical practice, subject to regulatory approval, based on its one to two treatment methodology, high efficacy and high safety profile. One day we hope that Ruvidar™ will become the organ-sparing solution that is a game-changer for both patients and physicians.”

From the ASCO-GU poster:

There have been eight Serious Adverse Events (“SAEs”) identified (2 Grade II (tachycardia, hematuria), 3 Grade III (acute kidney injury, cellulitis), 2 Grade IV (urosepsis, depression/anxiety) and 1 Grade V). None of the SAEs were deemed to be directly related to the Study Drug or Study Device according to the Data Safety Monitoring Board.

Source: https://theralase.com/wp-content/uploads/2023/02/2023-GU-ASCO-Poster-Presentation-02-01-2023.pdf
Comment by BlueFranky on Mar 14, 2023 9:17pm
SF... Your best post yet. Thank you!
Comment by CancerSlayer on Mar 15, 2023 12:39am
SF wrote:   "These "up to 9 new sites" could also be because the FDA wants 125 patients, instead of only 100, considering the 12 undertreated patients, in order to have a better picture.  But even there, even with these 12 undertreated patients, we already have excellent numbers (28% CR and 38% TR), despite them representing 41% of our 29 evaluable patients (12 NR out ...more  
Comment by N0taP00p on Mar 15, 2023 1:21am
Good post, Slayer. That's the main reason I invested. The immune response seems to be significant with relatively few treatments and if combined with other treatments, may prove much more potent across various cancer types. TLT needs good execution and negotiation skills to unlock full value. And money. 
Comment by Eoganacht on Mar 15, 2023 1:28pm
I agree that the addition of up to 9 new sites may be a positive signal about financing. The original plan was for 20 clinical sites and we currently have 11. But in 2022 Theralase starting talking about 15 potential study sites rather than 20 potential study sites (4 more rather than 9 more). I took this to be another economy measure, like the others we saw in 2022 - the employee cutbacks and the ...more  
Comment by ScienceFirst on Mar 15, 2023 1:43pm
Eoganacht ... Just like you, and because of our MOA that you described correctly, I don't see either how cancer cells could create resistance to our treatment as destruction happens "at speed of light", after TLD1433 integrated the cancer cells after mimicking being iron to them, after being instilled.
Comment by CancerSlayer on Mar 15, 2023 4:06pm
 Hi Eoganacht...always appreciate your responses. My statements re: treatment resistance (primary &nacquired resistance) had more to do with checkpoint inhibitors & other chemotherapeutics....not our unique ACT mechanism of action.  However, recent studies have also suggested that cancer cells may develop a level of ROS resistance &/or have a higher innate ability to ...more  
Comment by Eoganacht on Mar 15, 2023 4:43pm
Hi CancerSlayer - Thanks for that. It's a new area for me. I'm not sure if this ROS resistance applies to pdt or not because of the violence of the reaction when the PS is exposed to light and the immediacy of damage to surrounding tissue. "PDT uses a PS molecule as a prodrug that under light irradiation generates an intense blast of reactive oxygen species (ROS) such as superoxides  ...more  
Comment by CancerSlayer on Mar 16, 2023 3:46pm
  I agree...the intensity & immediacy of ROS production using our type of ACT overwhelms a cancer cell.  Imo, the ability of a cancer cell to survive our ACT more likely relates to inadequate delivery of PS to the cancer cell (causing a sub-cytotoxic level of PS within the cell) & not the mechanism of action of our PS/PDT.  The key for success in this case would be ...more  
Comment by CancerSlayer on Mar 16, 2023 4:22pm
  HOWEVER, I certainly can see a stand-alone approach (using our ACT) as being a good go-to option (or even first-line) for patients/docs who want to use a more patient-friendly "two treatment" option that is relatively cost-effective & that can deliver results.  Even in the instance a combo approach buys you a little more time, the negative impact on both one's ...more  
Comment by BlueFranky on Mar 16, 2023 4:33pm
a stand-alone approach (using our "ACT) as being a good go-to option (or even first-line) for patients/docs who want to use a more patient-friendly "two treatment" option that is relatively cost-effective & that can deliver results." CS: just reading that again puts both a furrow in my brow and a smile on my face Translation... How can we possibly be at this price ...more  
Comment by Eoganacht on Mar 16, 2023 10:04pm
Right. It's all about dosimetry with our ACT - both the PS dose and the light dose have to be exactly right for an effective treatment. Dr. Lilge stressed the importance of light dosimetry in the completed phase 1 trial in his 2019 AUA presentation. https://www.eventscribe.com/2019/AUA2019/fsPopup.asp?efp=VVZOVkFJT042MDYx&PresentationID=533969&rnd=0.9967567&mode=presinfo Results ...more  
Comment by Pandora on Mar 17, 2023 5:18pm
Anyone follow this tech at all? Just wondering. https://themarketherald.ca/defence-therapeutics-csedtc-to-develop-new-cancer-treatment-with-nuclear-energy-group-2023-03-14/?utm_source=stockhouse.com&utm_medium=widget&utm_campaign=stockhouse.com%7Cwebpart_news%7Cquote_tab
Comment by Infinity on Mar 17, 2023 5:31pm
Thank you Slayer,  Very informative post, strong reasoning.
Comment by N0taP00p on Mar 15, 2023 1:10am
You got 6 thumbs-ups for expanding on my previous post. Bah.  What an unfair virtual world we live in.  Kidding aside, you seem to be shifting away from 2023 as THE year and pushing 2025 as the year when the stairway to heaven opens up for the stock price.  I see the stock price at $5 minimum THIS year with BTD. With BTD, I also see JV happening by Q4.  With AA and Frontrunner ...more  
Comment by wildbird1 on Mar 19, 2023 9:27am
Eoganacht nice article....In the link that you provided, a team of scientists did use TLD-1433(provided by TLT) to find a possible treatment for Conjunctival Melanomia. 1) Conjunctival Melanomia is a rare but often deadly ocular cancer(it is increasing worldwide). 2) There is no FDA-approved systemic treatment for Conjunctival Melanomia, it is an incurable cancer. 3) In the article, after ...more  
Comment by Eoganacht on Mar 19, 2023 1:29pm
Hi wildbird1 - Yes, Theralase has so much research waiting in the wings. They just don't have the resources to take advantage of it. GBM and NSCLC treatments using systemically delivered and X-ray activated Rutherrin should be next up. If systemic instillation and X-ray activation goes well, there is the potential for treating many other forms of cancer. Then there's all the melanoma and ...more  
Comment by StevenBirch on Mar 19, 2023 2:27pm
So needless to say they are not sitting on their hands and would like to move this along just as quickly as we do.
Comment by Eoganacht on Mar 19, 2023 3:03pm
I think they're doing the best they can under the circumstances. The moment a big pharma comes to the realization that the main limitations of oncological  photodynamic therapy have been overcome and there is now a mind boggling profit poential in this technology, things will develop with great speed. IMHO.
Comment by CancerSlayer on Mar 21, 2023 1:26am
  Well said....Big Pharma has been asleep at the wheel re: the rapid evolution of PDT & PSs in the past decade.  Big Pharma seems to be oblivious to the potential of using the latest PS/PDT synergistically with various forms of cancer therapy.  Such synergism could not only potentiate efficacy & the anti-tumor immune response, but also help circumvent drug resistance & ...more  
Comment by Legit62 on Mar 21, 2023 7:02am
Cancerslayer, wouldnt you think by now these big Pharma have very very well educated scientists working for them and that they actually realize the benefits by now ?? I do, i also feel that we are very closely watched for years now and one or more of these big pharmas has us in the crosshairs and is ready to pounce once we get BTD and AA. So much for them to gain and so much more to lose if they ...more  
Comment by FGPstock on Mar 21, 2023 7:59am
legit, anyone of the big pharma companies could fart out more than a 25% stake in tlt. i would have expected it a long time ago, but for some reason no one takes this company seriously. We all keep waiting for next year/ next week, the clock is ticking. I would love to see anything to spike some interest so we don't get another PP at these low levels. we were promised covid and btd by now, tlt ...more  
Comment by Legit62 on Mar 21, 2023 10:20am
I just believe they dont want to sink money until this gets the FDA nod, but i got to admit this tree shaking is hard to watch, hopefully not much longer, but i feel for you
Comment by Eoganacht on Mar 21, 2023 9:31am
I think they're still shy of pdt for NMIBC because of the bad experience with photofrin. Photofrn was approved for NMIBC by Health Canada in 1996. It was abandoned because they got the dosimetry wrong and ended up damaging too much healthy tissue. An unacceptably high proportion of patients experienced underlying muscle damage which caused incontinence. This is  why Theralase has made ...more  
Comment by N0taP00p on Mar 21, 2023 9:53am
Eoganacht: You stated that 90% of their NRs are positive.  While I don't completely agree, I want that to be true this time.  A tiny company waiting 3 months to declare a quarterly report doesn't feel right to me, regardless of whether it's allowed by law and been done before.  Some have speculated that it could be because they want to include the maximum number of ...more  
Comment by Rumpl3StiltSkin on Mar 21, 2023 10:45am
In our(TLTs) favor is that Li Ka Shing is aware of this tech and has a need for it for their own Medical efforts. Also Roswell Park is well aware of this tech. Someone will be willing to pony up some dough $$$ early in the process. IMO. Even if big pharma sleeps.
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The Road to Saving Lives: Clinical Study Underway

  • Clinical Study with 68 of 100 Patients Treated (Enrollment to be completed by end of 2024, with study completed by end of 2026)
     
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Address:
41 Hollinger Road
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