Theralase Technologies Inc. V.TLT

Bored. Waiting. Here is some playing with data to look at.

[DJDawg]

I like playing around with patterns. Here is a URL pic of what I made recently as there is nothing else to do for now.

I took the swimmers plot and other data to generate a table to see some patterns.

-What do the under-treated 12 look like?

-What do the patients who start CR look like?

-What do the patients who start IR look like?

-What do the patients who start NR look like?

I tend to focus on the pure CR's that stay that way as they are different than the rest.

Love any corrections or feedback.

https://i.postimg.cc/tgpKJXvh/TLT-data-discussion.png

[riverrrow]

I feel, in theory at least, that there should never be a NR at start.  I expect that with experience  and technique improvements the CR will increase.  A CR of over 60% at day 360 seems quite achievable.  The current trial numbers are good enough for BTD immediately.  Hopefully the delay in being granted BTD is simply a case of making sure the paperwork is up to standards.

[Eoganacht]

Nice. Thanks. The statement "100% of CR at 360 stay that way at 450" is particularly gratifying. It bodes well for Ruvudar PDTs durable response at 24 months and beyond, particularly when compared with competing treatments, some of whuch experience significant declines in efficacy after 12 months in the absence of continuous treatments.  From the latest MD&A: "Patients

[Eoganacht]

In a recent interview Dr. Neil Shore is enthusiastic about the significance of the approval of Adstiladrin for BCG-unresponsive NMIBC patients, it had a durable complete response at 24 months of around 20%. "This is really great, because for these patients, who have CIS, who again, are BCG- unresponsive, what one would be potentially contemplating, or having the discussion with their

[DJDawg]

Great post Eog. The one thing that always bothers me about immunotherapy is how to quantify whether the benefit from the drug amounts to a cure and removal of all residual cancer cells vs the idea that the immune system is actively working on the cancer cells and keeping them below the threshold for cytology and cystoscopy to see the cancer present. With adstiladrin, based on the published data,

[Eoganacht]

Very interesting Dawg .That puts Ruvidar in an even stronger position than Adstiladrin as a treatment for NMIBC.. According to Theralase we are looking at a BCG-unresponsive NMIBC market of 9,251 patients per year. If all of those patients were treated with Ruvidar and 40% achieved CR that would mean 3,700 patients who were headed for cystectomy would be able to keep their bladders. If all 9

[99942Apophis]

I see we once again are using the "cure word" although its far too early for that title,  perhaps continued CR durability can be more accurate until a greater time frame can back it up.  Yes 40% is what we can be expected as a ok threshold for now however I believe most of us can hope for a strong possibility of reaching 55% or better for the final outcome.  Honestly I'

[GrahamB]

Agreed Still I haven't seem CR durability with this molecule in reports thus far-the phase 1 didnt reports and the recent phase IIb 40%CR was less than a year, and a interim analysis without full reporting of the data or imputation reported-certainly not durable from a clinicians or patients perspective, Perhaps Eon or others can provide a link to an RCT showing this Will be delighted to read

[Eoganacht]

I like the way they put it on WebMD - there is no cure for cancer but there are treatments that may cure some patients of some cancers. Is There A Cure For Cancer? In the current trial there are 13 patients who achieved a CR at 90 days who have continued to be completely free of any discernible sign of cancer at every assessment up to 450 days. Those 13 patients have effectively been cured of

[DJDawg]

Good quote Eog. I work in an area that sees patients with a different kind of cancer (thyroid). The nature of cancer is to proliferate and spread (locally or distant). The patients in these trials had cancers that were fast enough to proliferate that BCG didn't keep it down or remove it. If they were treated with an agent that was 98% effective but still ieft some 2% cells viable then those

[riverrrow]

Hi Dawg,  have you seen a big increase in thyroid cancer patients at your clinic since spring of 2021?  Asking for a friend.

[DJDawg]

No. Been steady the last 5 years for Thyroid cancer. At least where I work.

[Eoganacht]

Thanks for the great educational post Dawg. So that's how they do a urine cytology. In terms of a "cure" an important part of the treatment is that the cancer cell death induced by Ruvidar PDT is immunogenic, which is to say it generates a long lasting anti-tumour immune response along with an anti-cancer vaccination effect, such that if the same type of cancer recurs anywhere in

[DJDawg]

I really hope that the BTD application stands out because Ruvidar is one of the rare agents that does two methods of damaging the cancer. Most other agents are immuno only.

[GrahamB]

Interesting. Can you provide a reference for the "40% durable CR" noted in your post below? I read the phase I report, but there is no mention of this. In terms of durable can you also provide the duration ? Did they do a Cox Hazard model? Comment by Eoganachton Sep 24, 2023 4:12pm 153 Views  Post# 35651373 RE:RE:Bored. Waiting. Here

[N0taP00p]

@DJDawg:  Now that is what I call really good work!! Your summary table is very compelling.  This is the level of communication I'm hoping TLT is having with the FDA, if not with us.  Thanks again DJD.  Makes me want to buy more. But the tank's empty.  Let's hope to get some good news very soon.  It feels criminal to not release this therapy as soon as

[DJDawg]

I gather from what has been posted from people who went to AGM and other spots, that they have hired statistician for advice. I'm sure that they hired one of the FDA consultancy firms that are staffed by ex FDA staff. (ok, not sure, but it seems like an obvious thing to do). So hopefully they have better graphics than me :)

[Legit62]

Great work DDawg, great data chart and explanation, amazing how positive our data is compared to existing treatments

[Eoganacht]

It seems clear that if a patient does not have a CR at 90 days the treatment is ultimately not going to work for them. That's 24 out of 57 patients or 42%. I don't think it's lilkely that all of these patients have upper urinary tract carcinoma, so why doesn't the treatment work for them? It may not be of much interest right now but in the future maybe they can discover what is

[enriquesuave]

Nice chart dawg. For the NR and IR patients, perhaps they can optimize drug uptake by the cancer cells in some way?  Starve then of iron before treatment in order to increase Ruvidar uptake. Or add transferin to the mix?  Or maybe eventually combine Rutherin IV and Ruvidar instillation?  For sure there is some cancer cell destruction going on in these NR patients as well so maybe

[riverrrow]

Enrique, you posted some great fine tuning ideas.  Our patients need the BTD and final FDA approval so Ruvidar can get widespread usage and clinicians can fine tune the process and Ruvidar can save lives.  GLTA.

[DJDawg]

Here is a thought for RDW. Maybe recruitement of new patients would go better if they suggest that there is one treatment and if they are NR then they consider that NR for the duration and remove from study so patient can move on to another treatment. I think most of the research sites have several studies on the go so Ruvidar is competing for patients with other studies out of the same locations.

[patience69]

DJ I sent you a pm

[CAinPlap]

One question I have is if a patient receives only one treatment, how does this affect the data we are submitting to FDA for BTD approval? If the trial protocol is for 2 treatments 6 months apart, do patients who only receive one treatment count? In speaking to Roger, he indicated  some patients are opting not to get 2nd treatment.which I found surprising. 

[Eoganacht]

Some years ago a Theralase researcher said that the reason TLD1433 was used instead of Rutherrin in the NMIBC trial was simply because Rutherrin wasn"t ready yet. Maybe after Ruvidar is approved they could do another intravesical NMIBC trial using Rutherrin...

[Oilminerdeluxe]

Hopefully, BTD will be enough for the company to attract money right away and/or someone who wants to buy it. Would really like to see a GBM trial get going. Any thoughts on when AA might come once BTD has been awarded?