Theralase Technologies Inc. V.TLT

It's all about efficacy % as this what will lead us to a jv

[ScienceFirst]

The next update is all about efficacy of the optimized group of patients as they evolved toward durable response (DR).  Patient enrollment matters less as we could obtain revenues from them from the AA program if our efficacy are top of the line.  So durable response efficacy is what matters MOST at this point as they will mean 2 things;

- Accelerated approval, so revenues early 2023 from enrolled patients
- jv with a big pharma if higher efficacy than competitors

We already know that we are the only standalone treatment in the making.  Other current competitors (ImmunityBio and CG Oncology) are all combo treatments.  They both came up with giant leaps in terms of efficacy and low toxicity when compared to the actual BCG treatment that has been promoted over the last 40 years.  But they still require many treatments, as already documented many times.

So what will matter most in the next update is not much the new number of patients treated but rather the efficacy % of the already treated patients that belong to the optimized group, so we can see where we could land in terms of real durable response, assess how durable is our 2 doses treatment (if we make abstraction of the first 12 underdosed patients that have prevented us to see clearly into the real efficacy of our treatment). 

Will the tendency be 46%, 52%, 63%, 78%, etc ...???  That's what will help us confirm if we can dominate any other treatments of the late like ImmunityBio (N-803 + BCG) or CG Oncology (CG0070 + Keytruda) on the efficacy ground, as we already dominate them on the the low # of treatments and are pretty much head to head on the low toxicity aspect.

So if we want to act as a real eye-opener to big pharmas so one finally decides to make a move on us, the clearer and out-of-no-doubt efficacy % we have, the more we'll be able to make history by demonstrating out of no doubt that PDT/PDC is far more efficient than immunotherapies and that it has to be THE next field of interest of big pharmas in oncology.  And TLT will be identified as THE leader to team up with.  It all comes back to clear clinical data.  Nothing else.

Just imagine for a minute if the 11 pending status patients that had received their 2nd dose @180-day ALL turn CR @270-day.  THAT would be THE amazing signal long awaited.

I expect about 3 new patients enrolled since the last May 30 update.



November 29, 2021, Study II has enrolled and provided the primary study treatment for 30 patients (including three patients from the Study treated at the Therapeutic Dose) for a total of 33 patients


April 5, 2022 ... As previously announced, Theralase® successfully completed a Phase Ib NMIBC Clinical Study (“Study I”), which enrolled and provided the primary study treatment, at the therapeutic dose, for 3 patients. To date, Study II has enrolled and provided the primary study treatment for 35 patients, which when combined with the Study I data, leads to a total of 38 patients, who have received at a minimum, the primary study treatment.


May 30, 2022 ... To date, the phase II NMIBC clinical study has enrolled and provided the primary study treatment for 38 patients (including three patients from Phase Ib study treated at the Therapeutic Dose) for a total of 41 patients. 

[skys1]

SF, I agree with all you said except "we are pretty much head to head", with 803=BCG and CG0070+Keytruda on the low toxicity aspect. I had the opportunity to watch 2 neighbors suffer terribly every 3 weeks after their Keytruda treatments until they passed. Plus I have a very good friend in Maine that underwent 6 weeks of daily(except Sundays), radiation treatments with 1 oncologist and

[ScienceFirst]

Skys1 ... That's good input.  I'm aware that Keytruda has side effects.  I've seen them. I'm just reporting what I see from the combo treatment though.  Maybe in this combo, side effects are less, when compared to other trials.  So unless I'm proven wrong, I assume that low toxicity will not be such a differentiator.  So to me, the battle will come

[Rumpl3StiltSkin]

Hmm, if Sky's is correct in his observations. Maybe TLT will have an easy time in getting PDT over the hump. It will be the Docs, seeing what their patients go through, that will demand 1433, once it is approved. So maybe beating the competition by just a little, is enough? I think TLT can do this.

[skys1]

Hmm, TLT's ACT "has vertually no side effects" per Dr Sherri. That isn't "beating the competition by hust a little", it is blowing them away.

[ScienceFirst]

Between AE grade 1-2 and higher efficacy versus no side effect and a bit lower efficacy (let's say 10% points), to avoid losing your bladder, one will always go with the higher efficacy to put the maximum of chances on its side. We already know that we don't have much side-effects.  And from what I've seen so far regarding toxicity of competitors, they have also a very low

[CancerSlayer]

  Overall agree, but I think if we are within 5 to 10% efficacy as a "stand-alone" therapy, we will capture the attention of a more important partner, Smart Pharma.  Smart Pharma will know the benefits of having a safe & effective ACT in their back pockets that requires so few treatments (2 treatments with our ACT vs 38 individual treatments with CG0070 + Keytruda...21

[Rumpl3StiltSkin]

Yep, I agree with ya there Skys, I was talking about CR/PR %s of 1433 vs Keytruda + other Combo therapies. Of course TLT, as a stand alone, also beats them there.

[ScienceFirst]

Rumpl3 ... So far, with regards to efficacy %, we cannot state this with enough statistical significance.  Too early yet.  The next update can be a game changer though. Have you seen the CG0070 efficacy data?  On how many patients?   You still don't know their final numbers. Have you seen the ImmunityBio efficacy data?  We know their final numbers. We

[Rumpl3StiltSkin]

I agree SF,   Still a waiting game... I'd like to think we blow away those CR numbers. We'll see pretty soon.