Theralase Technologies Inc. V.TLT

$tltff The FDA wants an option that has rates better then

[floatinketucky]

flipping a coin.  

a 50 50  percent chance of keeping your bladder is not optimistic.

the FDA wants better numbers.

TLTFF study continues to treat patients and heal cancer.

TLTFF is the NMIBC nonresponse darling. 

The AEs are all resolved except for 1 grade 5 probally cause by an elderly patient or other factor then TLD-1433 OR THE DEVICE.

Theralase® believes all SAEs reported to date are unrelated to the Study Drug or Study Device, subject to final review and confirmation by the independent Data Safety Monitoring Board (“DSMB”).

[Rumpl3StiltSkin]

This patient population is elderly, fragile, who knows why they don't always have a CR at 90 days. 1433 has a log 3 kill rate in the test tube. If I were a NMIBC patiet I'd give it a try, certainly if they can get the 90 day CR % up into the 60s. IF I were then NR I'd try it again at the next 90 day period. Especially if I had a PR.... The safety profile is so low on this I can spend

[enriquesuave]

I personally think CR will be 70% plus at 90 days and around 50% at 6 months and 30-45% at 12 months on.  However anything significantly above Keytruda's 41% at 90 days and 19% at 12 months will look awesome and grant us an Approval IMO, given vastly better safety profile, better efficacy and patient friendly One single treatment option ( pleas a maintenance at 6 months)  All of this

[Rumpl3StiltSkin]

Thanks Enrique, That is great news. Glad you spoke to Dr. Mandel. I agree we should be pretty solid CR %s at 90 day. And, bcuz of the second treatment at 180 day, the 360day should also be solid. Maybe converting some PRs to CRs.... It is that 450 day mark that will be interesting? Should still be solid numbers then too, I'm guessing. :-)

[Eoganacht]

That's better than the (Keytruda superior) CR results of the1990's photofrin trial of 36 patients with CIS who received a single pdt treatment. More importantly, TLD1433 doesn't have photofrin's side effects. "At initial clinical evaluation at 3 months 58% of the patients had a complete response as indicated by negative cystoscopy, bladder biopsy and urine cytology but in 42%

[enriquesuave]

Nice find Eoganacht,  I wonder if we can get Health Canada Approval this year?  If They compare the Photofrin data with ours, even with the 38 treated patients, it won't take much to realize we have a major significant improvement in Safety and even Efficacy ( to be confirmed for 12 months data once all pending/ additional patients data comes in ).  Who knows?   Here is a

[ScienceFirst]

Eoganacht ... Great post. Very interesting that you bring back Photofrin's 1990 data, given that it was also with PDT and the fact that TLD-1433 is superior to it, and that we have all the other things (dosimetry, etc ...) also improved.  Our treatment also protect the bladder wall, contrary to Photofrin.  That was key to move forward. Things are looking great for Theralase. _____

[stocksnbonds458]

Perhaps a silly question, but say for example TLT's product was on the market and a patient knew they had a 70% chance be CR at 90 days, and only a 19% chance of being CR at 360 days. Knowing this could be a potential oucome, would not all patients request to continue to receive this treatment on a continuous basis , such that the likelihood of a return of cancer is unlikely? In other words

[stocksnbonds458]

Personally, if possible I would choose to receive this safe and harmless treatment every 180 days for the rest of my life. Why take a chance? This isn't dangerous like chemo or radiation

[socksnblonds642]

If I was BCG unresponsive and have a possible TBD CR of 70% and and if not could take something every 90 or 180 days and likely keep my bladder and on top of that  it's safe. Is that on the table! Been thinkin the same thing S&B. I don't know if it's that simple to equate. Time will tell but. I sure think that the current results point to BTD, the very essence of BTD. What is

[Infinity]

Socksandblonds, I believe you have a great suggestion. If you evaluate the PROs and CONs, any which way you like, the Patient will come out ahead. 1. It is fairly straight forward procedure. Compared to Bladder replacement. 2. Does not require Hospitalisation. 3. Cost effective, compared to Bladder removal. 4. Adverse effects are minimal and more easily manageable. 5. Substantialy improves quality

[ScienceFirst]

That's a bit what's happening with BCG.  You have the basic treatment and have maintenance.  And then, if you have recurrences, you could be given again the initial treatment if I'm not mistaken, if there's no other alternative. In the case if TLT's treatment, you would first have the current 2 dosing treatment.  After that, possible that a urologist could

[gojotv!]

You read the stats wrong, stocksnbonds... The response is actually proving to be pretty durable with our PDT. The 19% you see is the small minority of patients who have reached 360... In time, that percentage will balloon. But I'm actually glad the results are so hard for the uninitated to read... First, it allows the company to seem like they're underpromising while actually

[Rumpl3StiltSkin]

Not a silly Question S&B, That is the promise of 1433, a real non toxic treatment for cancer. Instead of Chemo... Some day. :-)

[CancerSlayer]

  And there's a good chance this current TLD 1433 protocol may just be the first iteration of this ACT for bladder cancer.   In order to address the non-responders, treatment refinements &/or additions will likely be sought/made over time.  This current form of ACT should not only advance in general (i.e. x-ray/other forms of activation, IV or systemic use of

[2b7f6fab]

The kil rate in vitro seems to be 100%.   Why aren't we seeing that in actual practice.  I'd like to see the solution that comes out of the bladder at the end of the procedure to be collected and analyzed for potency.  This could give us clues as to why there isn't a 100% CR.

[CancerSlayer]

  You make a good point...it would be valuable information to see what the concentration of that used solution would be.  Unfortunately, in vitro doesn't always translate perfectly.  Considering the human bladder isn't a perfectly flat/smooth surface (kind of mimics the WWI trench landscape wherein many cancer cells are hiding at the bottom of the trenches), the actual TLD

[Galaxym31]

maybe add some hydrostatic pressure on the solution in the bladder for a bit more penetration in the contours 

[enriquesuave]

I don't know if a low Iron diet for a full week before treatment would help?  Idea would be to deprive cancer cells such as to maximize uptake during treatment instillation.  Also have patients rotate in body position during drug instillation in order to maximize full contact of drug solution with all bladders surfaces during 1 hr drug instillation procedure? Anything to further help

[tdon1229]

  The standard laboratory wisdom is that you can kill almost anything in vitro with strawberry jam.  That's just one of many reasons clinical trials are performed. As for Theralase's treatment, if the trench analogy applies, then not only must the TLD-1433 reach the cancerous cells in order to be absorbed, but also the green light has to shine into those trenches with

[Gman620]

That's why the 'balloon' preparation effect is important to get the bladder wall as smooth and  uniform as possible prior to the treatment.

[CancerSlayer]

The updated protocol/bladder volume calculation (although not perfect) should help maximize the exposure/surface area of the inner bladder wall.  However, "old" bladders tend to be less expansile & this will pose an ongoing challenge imo.  I imagine over time there will be additional modifications made to help improve dosing, such as what enrique suggested (changing a

[enriquesuave]

If a patient is lying on his back, I suspect that the anterior-superior surface of the bladder may be less in full contact with the drug solution hence, if tumors are found there, they may take up less drug than fully immersed surfaces.  For sure there are probably occasional contractions of bladder to 'stir up' the solution, but just trying to find some potential factors to improve

[ScienceFirst]

They're already using this technique for BCG instillation.  Asking patients to move on both sides.  Instilling BCG or TLD-1433 is no difference in the procedure.  

[CancerSlayer]

  Agree...unlike treatment response outcomes, quality of life data is often overlooked or minimized by Big pharma, & yet such data is no less important to patients.  Best single agent in the making & possibly the best combo/adjuvant agent in the making.  Good luck...

[Gooseybear]

Having received 20 BCG treatments, cancer was reoccurring in the top of my bladder due to BCG not flowing into that area according to my Urologist. This was even after rotating every 15 minutes for two hours. He recommended an inversion machine and was to position to make the BCG available. Currently am NED thank God.

[CancerSlayer]

  Glad to hear you're disease-free.  You make an excellent point.  You can not only have variation in bladder wall architecture across individuals & within a single individual, but certainly the location of the cancer along the bladder wall lining will vary.  It stands to reason, this latter variation can make cancer less accessible  to topical treatments/bladder

[floatinketucky]

your coin was heads up.. Great.

[CancerSlayer]

  Good point...because of the bladder folds/rugae, there is the potential for variation in the dose of both drug & light.  Perhaps down the road, use of systemic Rutherrin can help maximize or achieve a more accurate drug dose?  And perhaps in the future alternative/additional activation techniques can be employed? In the meantime, I'm extremely happy with how we

[Eoganacht]

I think there are a number of reasons for that. A common problem with new treatments is that to get from pre-clinical to clinical results a treatment must pass through "The Valley of Death" Lost in translation: the valley of death across preclinical and clinical divide – identification of problems and overcoming obstacles More specifically, with in vitro phoyodynamic activation you

[socksnblonds642]

I was hoping for a PowerPoint but I guess this explanation will do!!

[BlueFranky]

Speaking of Dr lilge doing so very much without compensation... Eoganacht - may I repeat the sentiments of so many on this board, including myself Thank you for your continued efforts and insight, helping us common folk to understand even slightly better, the inner dynamics going on behind the curtain. Can't thank you enough.

[thadeush]

is it possible that the dosage rate is connected to other variables they may not have considered like blood type, tissue density, genetic markers, etc that might dictate the levels of light/photosensitizer (in addition to the characteristics of the bladder)?

[floatinketucky]

Yes these patients are up against a difficult decision. So the CR rartes and the safety profile are important.  Look the the consequence of the CR with storng percentages. vs the consequence of a CR that is like flipping a coin. The negative aspect of a procedure is outweighted by eleminating  the consequence.  The soft bashers are sweet and nice  but like to take me out