Theralase Technologies Inc. V.TLT

Patient #16, #17 & #18

[99942Apophis]

Patient # 16 was announced treated in the news release dated March 25/2021 plus 90 days puts he or her at the end of June.
Patients  # 17 & 18 were announced treated in the news release of April 27 plus 90 has them at the end of July. 
Waiting with high hopes that these three parents will show CR (complete response) moving the average up and eventually meeting criteria for Fast Track and Breakthrough. Also looking for increases in enrolled/treated patients now that Covid-19 is moving into the rear-view mirror.  In my biased opinion we are lining all the ducks up.

[99942Apophis]

repost  99942Apophis wrote Patient # 16 was announced treated in the news release dated March 25/2021 plus 90 days puts he or her at the end of June. Patients  # 17 & 18 were announced treated in the news release of April 27 plus 90 has them at the end of July.  Waiting with high hopes that these three parents will show CR (complete response) moving the average up and

[CancerSlayer]

  Hi Apophis...in my biased opinion, I agree ; ).   I also think we have an advantage simply based on the fact that our ACT is a "first-in-class" form of treatment that is under investigation for BCG-unresponsive NMIBC....& there currently is no other treatment in use that uses this same mechanism of action to destroy this type of cancer.  We have no similar

[99942Apophis]

CancerSlayer wrote       Hi Apophis...in my biased opinion, I agree ; ).   I also think we have an advantage simply based on the fact that our ACT is a "first-in-class" form of treatment that is under investigation for BCG-unresponsive NMIBC....& there currently is no other treatment in use that uses this same mechanism of action to destroy this type of

[CancerSlayer]

  I'm your neighbor from the South & hope for the same.  Hopefullly, hard lessons have been learned from the Pandemic, which should give rise to many more public-private collaborations (not unlike our very own TLT partnership with PHAC).  It appears the Feds in Canada are finally starting to recognize the strategic/economic/national health-related importance of having

[riverrrow]

So no new patient data to look forward to in the upcoming newsletter. Hopefully all the patients that were cancer free in the last update continue to be cancer free. This trial study is progressing beyond excruciatingly slow. GLTA.

[Pandora]

On March 25 they announced the launch of 6th U.S. site, on March 26 they announced the launch of the Anti Cancer Research Center, on April 9 they announced collaboration with the National Microbiology Laboratory on development of a coronavirus vaccine. On April 27 they put out the quarterly newsletter. Other than that it has been quiet "announcement wise" except for two financial

[CAinPlap]

We have several US sites approved but do we have any US patients treated yet? What is the bottleneck in getting new patients treated? Doctor training? Willing paticipants? Would it be realistic to expect one patient per site per month? If not, why?

[greaterfoolFred]

Our trial is more complicated than most.  For simple drug trials you just ship out a case of pills and some instructions, and you are set to go.  We have to ship out a laser system, then send a technician to set it up and verify it's operation.  After that the docs need training in it's operation and the medical procedure.  All this with covid.  I hope they are

[Yajne]

One patient treated in US to date although I can't find the release at the moment to confirm that. A huge surprise for me and likely others since they have avoided major hospitals for their US based CSS's which I thought would minimize COVID delays. If the snail could only crawl even slower....

[99942Apophis]

Correct Yajne This was announced in the news release for the 7th US site! To date, Study II has enrolled and provided the primary study treatment for 20 patients (including three patients from Phase Ib study treated at the Therapeutic Dose) for a total of 23 patients. Shawn Shirazi, PhD, Chief Executive Officer of Theralase®, stated, “It is exciting to see Theralase® clear another

[StevenBirch]

Don't you guys think we should wait for the next update, less than a month, before assuming that no more US patients have been treated? I understand the frustration but it is obvious now that the AGM was not going to reveal anything that we didn't already know. Besides, and maybe I missed it previously but I thought they needed a minimum of 25 treated and now it seems like 20 - 25 so we

[Longholder99]

I agree with SB. Lots of speculation on the negative side based on supposition only. This company drops big NRs without notice and isnt a mom and pop organization anymore. Playing cards close while vulnerable is the smart move. Things are movibg inbthe right direction and when the US public finds out abiut this procedure.....BCG will go the way of the tube TV.

[enriquesuave]

Even if they get 5 on 8 that would be great plus the 2 from PH1, that would be like 7 out 10 patients who got optimized procedure.  That would confirm a high efficacy for the market to understand what's going on here. All IMHO   

[DJDawg]

I'm bored so just writing things that I find interesting..... I think the issue is all about stats and probability. The patient's treated so far are a "sample" from the population of all patients out there. Regulatory bodies need to get enough data so that the sample tells them something meaningful about the true response if approved and given to everyone. If a company gets

[tamarindo1]

DJDawg: Good read, keep getting bored.

[CancerSlayer]

  Nice mental exercise & glad I'm not a statistician ; ).  Just some general thoughts for either new or old posters... Fortunately, achieving that magical CR% in "any" 25 patients (that can enable a BTD) is ultimately what counts in the near term, whether it includes the non-optimized patients or not.  Based on the technology's unique mechanism of action

[Rumpl3StiltSkin]

I'm guessing they'll keep treating patients in the US and Canada until they get these efficacy %s up where they want them, then they can halt phase 2. Around 40 or so patients? :-)

[Eoganacht]

I don't think they will halt the trial until they treat all 100-110 patients. If they get accelerated approval from the FDA one of the conditions of approval would likely be finishing the trial.

[Rumpl3StiltSkin]

Hey Hey! 100-110? Even better Cr %s numbers. ;-) Yeah Halt isn't the right word as the Phase 2 would transition to commercialization. Where insurance companies would then be paying for the study, along with TLT, instead of TLT paying for all of it.  

[enriquesuave]

Agree there Eoganacht.  If we do get Accelerated FDA Approval after say 40 patients, the FDA will tell the company to complete the trial which will serve as a confirmatory trial post accelerated approval.  Advantage is that the company would be able to start marketing drug treatment soon after accelerated approval and before completing entire trial.  We would need pretty good data

[CancerSlayer]

  Agree Eoganacht....the FDA would more than likely require post-marketing (post accelerated approval) confirmatory data as a condition for continued marketing/approval.  If data from the additional patients treated (for a total of 100-110) confirm data from the smaller approved cohort, all is good from there on.  JMHO.  

[StevenBirch]

Thanks everyone, great discussion.

[patience69]

Steven I sent you a pm

[Rumpl3StiltSkin]

Yep, It's always been 20-25. So we 'may' already be there, just depends on the FDA. I'm waiting for news on GLP, and definetly something from Dr. Kelbasa. perhaps a joint news conference with PHCA on the Canadian Covid 19 Vaccine/Treatment? A buyout, I would think, will be $1B US minimum on this Covid news. They'd be getting the cure for cancer as a bonus, afterall. ;-)

[Pandora]

I looked at the websites for the first 4 clinics in the U.S. that were announced as far back as January and only found one that even mentioned the study - but then my research skills may not be that good.