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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. > What happened to radachlorin pdt for NMIBC?
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Post by Eoganacht on Jul 25, 2022 3:34pm

What happened to radachlorin pdt for NMIBC?

60% recurrence free at 2.5 years after one treatment? Why haven't we heard more about this? What am I missing?

Efficacy and safety of photodynamic therapy for recurrent, high grade nonmuscle invasive bladder cancer refractory or intolerant to bacille Calmette-Gurin immunotherapy

Joo Yong Lee 1, Richilda Red Diaz, Kang Su Cho, Meng Shi Lim, Jae Seung Chung, Won Tae Kim, Won Sik Ham, Young Deuk Choi
 
Abstract
Purpose: We evaluated the effectiveness of photodynamic therapy using Radachlorin in patients with high grade, nonmuscle invasive bladder cancer refractory or intolerant to bacillus Calmette-Gurin therapy who refused radical cystectomy.
 
Materials and methods: Between July 2009 and December 2011 photodynamic therapy was performed in 22 men and 12 women. Radachlorin (0.5 to 0.6 mg/kg) was injected intravenously 2 to 3 hours before photodynamic therapy. After complete transurethral resection, a diffuser using a 22Fr cystoscope was placed in the bladder for irradiation with a 662 nm laser. Output beam power was adjusted to 1.8 W and the light dose was 15 J/cm(2). Photodynamic therapy was performed for 16 to 30 minutes. Recurrence after photodynamic therapy was followed by regular cystoscopy at 1, 2 and 3 months, and at 3-month intervals thereafter for up to 2.8 years. Efficacy was assessed by cystoscopy, cytology and histology, and defined as the number of patients who were tumor free after initial photodynamic therapy.
 
Results: Mean ± SD patient age was 62.94 ± 8.71 years. Average followup was 26.74 ± 6.34 months (median 28.12). As the primary efficacy outcome, the recurrence-free rate was 90.9% at 12 months, 64.4% at 24 months and 60.1% at 30 months. As the secondary efficacy outcome, there was no statistical difference in mass size, carcinoma in situ, number of previous bacillus Calmette-Gurin administrations, number of transurethral bladder resections or tumor multiplicity on Kaplan-Meier analysis (each p >0.05). No evidence of severe adverse effects was detected after photodynamic therapy.
 
Conclusions: Photodynamic therapy with Radachlorin is a safe, effective treatment for nonmuscle invasive bladder cancer refractory or intolerant to bacillus Calmette-Gurin therapy in select patients.
Comment by Rumpl3StiltSkin on Jul 25, 2022 3:45pm
Did they ever go for FDA approval?
Comment by Eoganacht on Jul 25, 2022 3:58pm
I don't think they did. They got those fantastic results in 2013 then it looks like they dropped it.
Comment by Mongoose1975 on Jul 25, 2022 4:38pm
i It's made in Russia, if that says anything
Comment by ScienceFirst on Jul 25, 2022 4:42pm
They never got FDA approval because they never did a Ph. 2 in the US.     Nov. 2021 - Current status of photodynamic technology for urothelial cancer   ...     Although ALA-PDT is yet to be approved for use as a treatment for bladder cancer, it is a highly accurate and minimally invasive procedure that is widely applicable and may replace ...more  
Comment by Eoganacht on Jul 25, 2022 5:17pm
I found some more up to date results and it seems radachlorin does not have as good a durable response as the Korean study indicated. It's more like 35% at 2 years not 60%.- which is still good but not incredible. "In particular, the TURB + PDT treatment with ALA and “Radachlorin” provided 78% and 91% complete response rates, respectively, at 12 months after follow-up [4,8]. However, by ...more  
Comment by ScienceFirst on Jul 25, 2022 5:28pm
Great digging Eoganacht.
Comment by Rumpl3StiltSkin on Jul 25, 2022 5:32pm
Ah, 35% still good tho as you say. Didn't Dr. M say 'great' for 35%?
Comment by ScienceFirst on Jul 25, 2022 6:07pm
We have to give credit to TLT that does everything by the book and never cut corners when it comes to what the FDA/HC/EU require in terms of papers and rigorous standards. By teaming up with UHN and PMCC, we were sure to never have a flawed study.  TOOKAD and Radachlorin seem to have taken a shorted route that lead them nowhere.  That's usually what happen when you cut corners. I ...more  
Comment by 2b7f6fab on Jul 26, 2022 12:50am
I appreciate all your contributions SF.  However UHN undertreating the first 12 patients of PH2 has set this company back at least 2 years and that was after they successfully applied the so called optimized procedure to patients 4~6 in PH1.  After that tremendous FU I would never recommend anyone get treated at UHN PMCC..  I don't have years and years to piss away unlike the ...more  
Comment by FGPstock on Jul 26, 2022 8:12am
By the book, tha's comical. TLT has its own book it follows. Ben, do you work for them as your jedgment is very clouded. Was it "by the book" when roger claimed tlt's lasers were FDA and HC approved when TLT hadn't even filed for approval. How can you b taken seriously if you don't have the ability to b objective. I don't believe we would be at 27 cents if manangeent ...more  
Comment by ScienceFirst on Jul 26, 2022 8:43am
FGPstock ...  Still a grumbler? You sound like the guy that asked the OSC to investigate Roger and that wanted his head as you always come back with more and more details.  So funny. There are always armchair quarterbacks like you on SH.  Bungee used to be our famous one.  His wife has probably removed him access to SH.  Poor libertarian.  You sound so much like him ...more  
Comment by cashworx31 on Jul 26, 2022 8:58am
This post has been removed in accordance with Community Policy
Comment by Lesalpes29 on Jul 26, 2022 10:08am
One important thing in investing is a management you can trust. Seem the missing piece for you FGP. What are you doing here? If you have a problem with SF just ignore him. For me SF is posting important informations.
Comment by CancerSlayer on Jul 25, 2022 10:06pm
  "....recurrence rate achieved for the Radachlorin group was 35%"....very unusual statement imo.  If the recurrence rate by 2 years was 35%, that would imply a durable response rate of 65%.  Did they mean to say recurrence-free or disease-free survival? The study was underpowered with only 34 total patients, however, even a 35% durable response rate at 2 years ...more  
Comment by Rumpl3StiltSkin on Jul 25, 2022 5:30pm
Yes, the question is why? These results should have got the funding to do a phase 2. TLT the door is wide open! :-)
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