Theralase Technologies Inc. V.TLT

88% TR @90-days if you exclude 10 of the undertreated

[ScienceFirst]

Same exercice but this time for TR (CR + IR) ... as TR is what the FDA is looking for, on top of CR.

Putting aside the 10 worse evaluable patients (the 10 undertreated that never went further than 90-days (they are the first 10 patients from the bottom (those with a red point) on the Patient Response chart), TR from all the others (so 2 from the undertreated + all the optimized patients) is 87.9% CR @90-days:

- 4 red (NR)
- 6 green (IR)
- 23 green (CR)

23 CR + 6 IR = 29 TR / 33 evaluable patients (if we exclude 10 undertreated) = 87.9%

It pretty fits the ranges that I recently posted (see below).  We now have better quality of data to assess with better accuracy what the upcoming 50 next patients could deliver. 

So it's impossible for the FDA to ignore such high rate of efficacy, given the low number of doses, the absence if exclusion criterias, the low side effects, etc ...  Such treatment could delya or avoid cystectomy.

Without the undertreated pool of patients, we would have flirted with very convincing efficacy data (CR @90-days) around 70%.  That's enough to grant us Breakthrough Therapy designation.  And if 9 other CSS join our Ph. 2, but with a cohort that adds lets say 2 additional treatements (4 in total), we could see higher efficacy data.

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Post by ScienceFirston Feb 06, 2023 9:46pm

304 Views 

 Post# 35270832

%s of the optimized group @90-days: 74.3% CR and 95.7% TR

Considering this, in the Jan. 3rd article:

 

In November 2022, Theralase reported encouraging interim clinical data from the pivotal clinical study, with 53% (43 evaluable patients) achieving a complete response at 90 days; 29% (34 evaluable patients) at 360 days; and 28% (29 evaluable patients) at 450 days.

Including patients with an indeterminate response (negative cystoscopy and positive urine cytology, where upper of lower tract UCC has not been identified but is still under investigation by the clinical study sites) patients exhibited a total response are 67% at 90 days; 44% at 360 days; and 38% at 450 days.

1) CR @90-days for the optimized group: 

 

Lets try to assess the CR @90-days in order to have a better understanding of where we could be heading, the more we had new patients.

 

43 evaluable patients = 3 from Ph. 1b + 12 undertreated + 28 optimized patients

 

53% of 43 patients = 22.8 CR patients @90-days

 

Lets assume 0 CR patients @90-days from the 12 undertreated for a moment, to play this very conservative.  
 

That would be 22.8 CR patients @90-days  -  2 CR patients @90-days from Ph. 1b (p#5-6).  So 20.8 CR patients @90-days  patients from the optimized group.

 

20.8 CR patients @90-days  out of 28 from the optimized group = 74.3% CR patients @90-days   

 

 

2) TR @90-days for the optimized group:

 

Lets try to assess the TR @90-days in order to have a better understanding of where we could be heading, the more we had new patients.

 

43 evaluable patients = 3 from Ph. 1b + 12 undertreated + 28 optimized

 

67% of 43 patients = 28.8 TR patients @90-days

 

Lets assume 0 TR patients @90-days from the 12 undertreated for a moment, to play this very conservative.  
 

That would be 28.8 TR patients @90-days  -  2 TR patients @90-days from Ph. 1b (p#5-6).  So 26.8 TR patients @90-days patients from the optimized group.

 

26.8 TR patients @90-days out of 28 from the optimized group = 95.7% TR patients @90-days

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More realistic though ...

 

But my assumptions of 0 out of the 12 undertreated patients had any results (were all NR) inflates these % a bit.  Assuming 3 out of 12 undertreated had lets say PR (partial responses), that would rather give these results:

 

 

That would be 22.8 CR patients @90-days  -  2 CR patients @90-days from Ph. 1b (p#5-6) - 3 TR patients @90-days from the undertreated..  So 17.8 CR patients @90-days  patients from the optimized group.

 

17.8 CR patients @90-days  out of 28 from the optimized group = 63.5% CR patients @90-days

 

 

That would be 28.8 TR patients @90-days  -  2 TR patients @90-days from Ph. 1b (p#5-6) - 3 TR patients @90-days from the undertreated.  So 23.8 TR patients @90-days patients from the optimized group.

 

23.8 TR patients @90-days out of 28 from the optimized group = 85.0% TR patients @90-days

 

[ScienceFirst]

ScienceFirst - (2/20/2023 6:35:29 PM) 88% TR @90-days if you exclude 10 of the undertreated Same exercice but this time for TR (CR + IR) ... as TR is what the FDA is looking for, on top of CR. Putting aside the 10 worse evaluable patients (the 10 undertreated that never went further than 90-days (they are the first 10 patients from the bottom (those with a red point) on the Patient