Theralase Technologies Inc. V.TLT

Adstiladrin data shown at end of Nov at big UroOncology meet

[DJDawg]

I don't see the poster available online from their presentation but there are some interesting points.

The protocol allows them to keep treating responders ever 3months AFTER the initial 4 dose protocol. So they are still treating the responders, just not sure how many till see posters. So some/many/all (?) get the main study treatment every 3 months for years(?).

Despite that, of the 55 responders from the initial 103 patients, they get steady fall off in patients who are disease free.

High grade disease recurrence free numbers are
3 months - 55 patients
6 months - 42
9 months - 36
12 months - 25
24 months - 20
36 months - 14  ( 13.5% CR rate if you use the original 103 patients)

Any bladder cancer disease free numbers are worse
3 months - 55 patients
6 months - 38
9 months - 36
12 months - 25
24 months - 15
36 months - 12 (11.6% CR rate if you use the original 103 patients.

However, they are very sneaky in how they sell it. The wording is 25% keep their CR. As in, of the 55 who responded at all at 3m, 25% kept their response. Not that impressive to me.


https://www.urotoday.com/conference-highlights/suo-2023/suo-2023-bladder-cancer/148294-suo-2023-efficacy-of-intravesical-nadofaragene-firadenovec-vcng-for-patients-with-bacillus-calmette-guerin-unresponsive-carcinoma-in-situ-of-the-bladder-36-month-follow-up-from-a-phase-3-trial.html

[Eoganacht]

It seems that after 12 months, any patient that does not experience high grade recurrence will receive another treatment every three months as part of the 5 year treatment/followup. I would guess that all 14 of the 36 month high grade recurrence free patients have received 12 treatments - one every 3 months since the beginning of the trial, and they will continue to receive them for up to 5 years

[DJDawg]

The more I think of it this is the worst data for adstiladrin. I really shows that you do all these expensive bladder instillations (6 induction plus 12 per year for total of 30 in 3 years) and no patient really gets to feel like they are in the clear. By 3 years there is only a 1/8ish chance of being CR still. In a way it is lucky to have this data BEFORE BTD submission as now TLT can really

[Eoganacht]

I totally agree Dawg, except I think you got the number of treatments wrong. I think it's 12 treatments at 3 years not 30. "...From the outset, patients with NMIBC CIS±Ta/T1 received ADSTILADRIN 75 mL intravesical instillation (3 x 1011 vp) once every three months for up to 12 months (four doses) or until unacceptable toxicity or recurrent high-grade (HG) NMIBC. Patients

[DJDawg]

Yes. 12! Plus 6 at induction my brain was thinking monthly

[Pandora]

Another entry into the field of cancer trials:   Defence may proceed with AccuTOX phase 1 clinical trial   2023-12-11 12:42 ET - News Release   Mr. Sebastien Plouffe reports DEFENCE RECEIVES FDA APPROVAL FOR PHASE I CLINICAL TRIAL TARGETING SOLID CANCER TUMORS WITH ACCUTOX(R) Defence Therapeutics Inc. has received a study may proceed clearance from the United States

[Alamir1111]

I would take Dts sp right now

[DJDawg]

The poster for Adstiladrin was released and it didn't really give a lot of specifics beyond what we know. https://qr.apothecomcx.com/review/qrcodes/150204661-18/150204661_18_36_Month_Followup_CIS_Poster.pdf I hope TLT points out to the FDA that the panel recommended: 40%-50% at 6 months (note that they don't list 3m CR or CR at any time) 30% for 18-24 months, with the lower