Theralase Technologies Inc. V.TLT

Politics Aside

[CancerSlayer]

BCG has a failure rate of up to 40% for high-grade NMIBC.  Based on which study you look at, add another ~7 to 20% who are considered BCG intolerant (I.e. had to discontinue BCG treatment due to treatment-related morbidity/toxicity).  Additionally, there was an overall 15-40% noncompliance rate noted after 1 year of BCG treatment based on two international studies done in the past 8 years.  Even though the interim data from ImmunityBio's N-803 + BCG combo trials show promise (for BCG-unresponsive & BCG-naive patients), such a protocol can't avoid the reality of BCG intolerance & the requisite treatment-intensive protocol that is so patient "unfriendly" in terms of quality of life/personal-social impact, which further increases the likelihood of treatment noncompliance....all imo.

Combine the above with the reality of the ongoing BCG shortage, high BCG/combo treatment costs & low efficacy rates of the two currently approved drugs, there should be significant opportunities for emerging novel treatments to capture a good portion of the market imo.

A journal excerpt re: BCG toxicity...

Efficacy and toxicity of intravesical Bacillus Calmette-Gurin therapy in elderly patients with non-muscle-invasive bladder cancer

Matsuoka, Yuki; Taoka, Rikiya^∗; Kohashiguchi, Kana; Tohi, Yoichiro; Miyauchi, Yasuyuki; Kato, Takuma; Tsunemori, Hiroyuki; Ueda, Nobufumi; Sugimoto, Mikio

Author Information 

Current Urology: March 2021 - Volume 15 - Issue 1 - p 16-21
 

"With regard to toxicity, Oddens et al.^[22] reported that the percentage of patients who discontinued BCG therapy due to toxicity was 17.9% for patients aged ≤60 years, 21.9% for patients aged 61–70 years, 22.9% for patients aged 71–75 years, and 16.4% for patients aged >75 years. In terms of systemic and local side effects, there was no significant difference between each age group. However, Heiner et al.^[23] reported that the complication rate for intravesical BCG was 17.6% for patients <70 years old and 48.6% for patients ≥70 years old. They concluded that BCG should be administered with caution in patients aged >70 years and should be avoided in patients aged >80 years." 

 

 

 

[enriquesuave]

I'm hoping we can get 3 out the next 6 CR or better. ( even 2 out of 6 would be decent). That would make it 7 out of 12 patients who got optimized treatment in PH2  or 9 out of 14 if we include the 2 from PH1 who also get an optimized treatment.  We would be beating competition at 3 months data and with only one single treatment Vs many many more.  Of course anything better and

[DJDawg]

Sounds good Enrique. Is it my understanding that we would be expecting data back on 6 with the end November update? Does that timeline work? I have trouble keep track.

[Oilminerdeluxe]

3 for 4 would be nice. But it's Theralase, we could go 100 for 100 and still be below rat levels. Just a few agonizingly long weeks to wait. Will have a purse of coins ready by then. Have a blessed weekend all.

[enriquesuave]

It all depends on what data the Principal Investigator shares with Theralase and how much data was collected.  As of August 30, they had treated an additional 6 patients on which we have not seen data yet.  So November 30 is 90 days  data collection is 90 days +/- 7 days so it could be that we get an update on up to 6 patients #´s 19, 20, 21, 22, 23 and 24.  I'm hoping

[CancerSlayer]

  Thanks for keeping track of the optimized treatment numbers...it can be a blur sometimes.  Just hoping the team spells out this data clearly in their next update.  Really liking our simplified two-treatment approach, which most definitely should encourage patient enrollment/retention.   On the flip-side, the treatment burden & side effects of the other "treatment

[Rumpl3StiltSkin]

Great points Slayer!

[Oilminerdeluxe]

So they hiring people? That usually costs money. Have they found additional funds somewhere?

[socksnblonds642]

Some of the hires are replacements or were dual roles so these salaries have likely been in their budget  but yes apparently they've all  been filled. 

[Oilminerdeluxe]

Ok, thanks.

[socksnblonds642]

This study concluded that there was no difference in efficacy based on age. The Heiner and Oddens studies that you referenced are completely separate studies that conflict with the main article. They show this out of due diligence I guess. They site limitations due to the size. 87 patients. Conflicting results though... in one study there appears to be no difference based on age and in other