Theralase Technologies Inc. V.TLT

Maintenance Dose

[RoseHeaven]

They are giving maintenance dose only to 26 (15 done+11 pending) out of 38 patients treated in Phase II. Does it mean that all 12 underdosed patients were excluded from the maintenance dosage? If underdosed patients were excluded, why they count them as EVALUABLE patients in determining response rate? 

I don't get it, will appreciate if anybody could help me to understand.

Thanks

[ScienceFirst]

For the 12 underdosed, I think their "maintenance" dose was called differently, given that this was more complicated for some of them.  I would have to re-check.

[Rumpl3StiltSkin]

Rose, I think some of the first 12 were disqualified from continuing in the Study 2, for whatever reasons. Others were given the 'proper' second dose. I don't have hard numbers for this. I think it is about half of the 12.

[RoseHeaven]

I believe majority of NR cases are coming from 12 underdosed patients which are partially or fully dropped from the maintenance dosage. As per  news relkease, total 12 patients out of 38 (32%) in Phase II were disqualified for maintenance dose but counting those 12 patients in calculating response rates. This might be skewing response rates significantly to the downside.    

[langosta]

Still discussing or trying to interpret the status of the 12 underdosed patients. A little bit of plainspeak from the company wouldn't hurt. 

[99942Apophis]

RoseHeaven 5 of the 12 were removed from the study and are still used in the participating numbers. I could be wrong in that at the conclusion those 5 being removed won't be included in the overall results in the US version however its my opinion that here in Canada they are still included in overall results. In my personal chart I omit those 5.

[RoseHeaven]

Hi 99942Apophis, once you remove those from calculation, how the response rates look like at various time frame?  Thanks

[99942Apophis]

I am reluctant to post my numbers for the fact that those numbers are not officially accepted. RoseHeaven of course CR percentages do rise if you reduce the removed group from the overall calculation. You sound like a previous boss I once had if he didn't like my numbers I had to make them come out to what he liked to see hahaha.

[RoseHeaven]

Thanks 99942Apophis. I did my calculation exlcuding dropped out patients and feel better about my investment with TLT.  Cheers

[Rumpl3StiltSkin]

I am hoping that the market focuses on the treatment  'optimized' patients. Even with the skewed numbers TLT1433 will still beat Keytruda. Especially from the POV of patients/Doctors regarding safety and number of treatents, etc. :-)

[Rumpl3StiltSkin]

BTW, should we be referring to the second treatment of this Study 2 as a 'Maintenance Dose'? The real question is did the 7 of the 12 that are still part of this, did they receive that second treatment as 'optimized' ??

[Rumpl3StiltSkin]

I am guessing they did...

[ScienceFirst]

Yes to your 2 questions.  It's all in the MD&As and newsletters

[Eoganacht]

4 of the 7 who received a second treatment received the optimized treatment. So 5 of the 12 are out of the trial, 3 received 2 unoptimized treatments and 4 recieved 1 unoptimized treatment and 1 optimized treatment. News Release Sept. 24, 2020 "Study II has enrolled and treated 12 patients to date. Out of the 7 patients that are eligible to receive the second treatment, 5 have been treated

[Rumpl3StiltSkin]

Thanks Eoga!

[Pandora]

The wording as noted before could certainly be better formatted. I took a stab at slightly different wording below which makes it easier for me to understand but others may disagree. What it leaves me with is another question. 7 out of 12 were eligible for further treatment. Doesn't mention where the 5 ineligible patients went. Must we "assume" they were removed from the study? It

[RoseHeaven]

Still the questions remained about the # of patients and maintenance dosage: 1) 5 did not get 2nd treatment from 12 underdosed patients 2) 1 patient died  This makes a total of 6, but the total number of patients did not get 2nd dose is 12 as indicated in May 30 Management Discussion. Where this remmaining 6 is coming from?  Any thoughts?

[Pandora]

Oops, Eoganacht I see I am repeating much of what you said and you used fewer words in doing so. I see you also clarify the 4 as having 1 unoptimized treatment and 1 optimized treatment wheras I used the term fully optimized. If the "3" received a second treatment why would it not have been the optimized treatment? Does that suggest they still were not aware of the dosage discrepancy

[wildbird1]

Pandora...Good question. Just an hypothesis, maybe the 3 patients you are talking about were CR patients (Complete Response), if so there was no need for the optimised treatment.

[Pandora]

Wildbird1 in a sports mode when a person sets a record but it happens to be because of some circumstance or situation that is not considered normal then the record gets an * beside it. In our case it seems our first eight patients should be asterisked as long as they are part of the database. :-)) It seems whether we have 41 or 71 or 101 in the database then those 8 undertreated patients will

[Legit62]

Yes those 8 patients numbers will fade as more patients enter trial, but im sure the FDA knows exactly how to decipher the positive results with minimal to no side affects and low number of treatments, this will far out weigh those 8 patients. Plus cost of tx lot less than competitors, just a matter of when results are in enough for us to get BTD IMO, staying very positive, plus there will be many

[wildbird1]

Pandora... the 12 undertreated patients are confusing almost everybody, but there is something that should help us, the next Dec 2022 CR% results. The FDA said that for BTD, TLT need 20 to 25 patients treated with 66%CR. In Dec 2022, out of the 28 patients left(33-5), 18 will be optimized patients that have completed the 450 days(Dec 2022) + 2 CR from phase1b(3Q2021 News Letter). And these 18

[Eoganacht]

Hi Pandora - all of the first 12 patients were undertreated in their first treatment. 5 of these 12 were removed from the trial (no response patients) The remaining 7 patients from the first 12 received a second treatment at 180 days The first 3 of the 7 were also undertreated in their second treatment because they had not come up with the optimized treatment yet. The remaining 4 of the 7

[Pandora]

So the first 8 of the first 12 are effectively not countable for study purposes - in our amateur look at things? Yet they are included? Presumably Study regulations do not allow deleting any patients from the data base regardless of the circumstances. When reference is made in Study II data to 38 patients - or now 41 patients, those 8 are still included? They have not reverted numbers back to 30

[Eoganacht]

Hi Pandora - yes, the 41 patients mentioned in Tuesday's news release includes all of the patients who have been treated in the phase 2 trial so far.