Theralase Technologies Inc. V.TLT

One more look at the new 90 day optimized data

[Eoganacht]

I changed the percentages to patient counts for the recent 90 day numbers for the:

23 patients enrolled and treated in Study II who received an optimized primary study treatment

CR = 12
PR = 4
Pending = 3
NR = 4
Potential CR = 82%

In the last newsletter there were 18 post-Aug 20 2020 optimized patients

CR = 8
PR = 2
Pending = 7
NR = 1
Potential CR = 94.4%

In the period between the two news releases 7 patients reached 90 days and 5 more patients were treated for a total of 12 patients. Of these 12 patients there were:

CR = 4
PR = 2
Pending = 3
NR = 3
Potential CR = 75%

Out of these 12 patients 3 patients (25%) were NR. The results of just these 3 patients accounts for the drop in 90 day potential CR. We will probably never know what happened with these 3 probably very sick and elderly patients but given where we are in the trial it will likely have little overall effect. If you flip a coin 12 times you won't likely get 6 heads and 6 tails. You might get 4 tails and 8 heads. But if you fip a coin 100 times it will be much closer to 50% heads and 50% tails. If those 3 patients had been CR or PR we would have a 90 day potential CR of 96% and the sp would have reached new heights IMHO. But this isn't the first time Theralase's sp has taken an unexpected and unwarranted hit.

[Rumpl3StiltSkin]

I agree Eoga and nice Job, Yet even if TLT had put your analysis out there they still might have sold off 30%. Look at what happened to Briacell after annoucning they gained FastTrack status!!

[fredgoodwinson]

Thanks Eog - you have long been far and away the best source of information for Shareholders here.

[enriquesuave]

Excellent post and observations.  I thought of roughly the same thing as in a small sample it only takes a few patients to significantly change the numbers.  I expect a gradual increase in CR numbers as more and more data comes in.  Overall the data is already showing better numbers than Keytruda and should further improve over time. All IMO  

[ScienceFirst]

Nice post Eoganacht.  Thanks for sharing. ________________________________ Eoganacht - (4/18/2022 5:44:29 PM) One more look at the new 90 day optimized data I changed the percentages to patient counts for the recent 90 day numbers for the: 23 patients enrolled and treated in Study II who received an optimized primary study treatment CR = 12 PR = 4 Pending

[Infinity]

Thank you Eoganacht,  Finally some clarity on the data.  I wish the management would take more pride in their work and put out a more informative up date on a periodic basis to indicate that they value their stake holders.  I am not too impressed with another poster who thinks that Roger Buying stock is more important than any updates.  That seems very condesending to say the

[CancerSlayer]

  Thanks for beating me to the punch Eoganacht ; )...The absolute numbers certainly paint a more clear & rosy picture of where the data is truly heading. For those few who convert from CR/PR to NR, I'm still hoping such patients in the future could benefit from an additional treatment(s).  If the ACT was proven to work once, it's certainly plausible it can work again

[CancerSlayer]

  comorbities = comorbidities.  My iPad must have thought there were too many syllables ; )

[Rumpl3StiltSkin]

Agree Slayer, Because of 1433s safety profile, why not keep trying it? If it doesn't work the first time it could always work the second or third or forth attempt.

[enriquesuave]

An analysis of NR patients in overall data on all 38 patients, we have 3 patients from PH1: 2 CR post 450 days ( who received an Optimized Treatment) and 1 NR ( non optimized treatment)who probably had metastatic disease prior to treatment undiagnosed.  That 1 NR patient should have probably not been included in trial or data. 1st set of 12 PH2 patients who were undertreated by 39-85

[Eoganacht]

Great analysis. 54% CR at  450 days is 24% higher than the FDA benchmark of 30% CR at 18 to 24 months which, according to ImmunityBio, was deemed "likely too high and may not be realistically achievable". https://immunitybio.com/immunitybio-announces-over-24-months-median-duration-of-complete-remission-with-100-nmibc-cis-patient-survival-setting-a-new-magnitude-of-benefit-in

[enriquesuave]

In the Keytruda trial, 5 patients were droppe from the 101 who got treated as they had not met disease definition of BCG Unresponsive NMIBC as per FDA.  The FDA can and should take into account these 7 anomalies in our data IMHO  "101 eligible patients were enrolled and assigned to receive pembrolizumab. All 101 patients received at least one dose of the study drug and were

[Eoganacht]

Even 25%-30% CR at 450 days is a much better result than that achieved by the FDA-approved Keytruda. The Theralase phase 2 results achieved so far look very positive given expectations. "For the population of patients for whom bacillus Calmette-Gurin (BCG) has failed, the type of failure (BCG unresponsive, refractory, relapsing, or intolerant) should be clearly defined to make comparisons

[Gooseybear]

I've had T1 NMIBC CIS on and off since 2017 and 20 BCG treatments. I mentioned Ketruda to my Urologist and he said no way, that the side effects are worse than the disease and it should be used for more aggressive treatment. 

[Rumpl3StiltSkin]

Very interesting GB, Sorry you are going through this and hope TLT comes through for you and other NMIBC patients. It certainly looks like 1433 will be a big improvement, over Keytruda, once that BTD and AA are approved. :-)

[CancerSlayer]

Yep...& at the time that 30% FDA benchmark was made, it was a fairly subjective decision agreed upon by just a few experts.  Practically speaking, our single-agent competition (Keytruda) recently set our new benchmarks imho....41% CR, 19% CR at 12 months, & 11% still responding at 24 months.  The median duration of response (mDOR) was ~16 months.   The mDOR is defined as

[CancerSlayer]

Forgot to mention:  The duration of response is an equally important benchmark.  I'd much rather have a "meaningful" delay in cancer progression (i.e. unchanged CIS) than a CR that has no lasting benefit.  That 18 to 24 month data is no less important than the CR data.  While we await the BTD, key Study II data remain an unknown.  Still plenty of time before