Theralase Technologies Inc. V.TLT

Optimal Management of Bacillus Calmette-Guérin–Refractory No

[Oden6570]

Photodynamic Therapy

In 2023, interim findings were released, detailing the outcomes of a phase 2 clinical study on intravesical photodynamic therapy for patients with BCG-unresponsive CIS with or without papillary disease (NCT03945162) [42]. The study involved intravesical instillation of the photosensitizer TLD-1433 (0.70 mg/cm2), followed by activation using a 520-nm intravesical laser (Study Device TLC-3200) and consequently delivering a total of 90 J/cm2 of laser light under general anesthesia. Among the 45 enrolled patients, the data showed CR rates of 50% at 90 days, 35% at 360 days, and 21% at 450 days. Eight serious adverse events were identified in the study. The study is currently ongoing, with recruitment in progress, and the estimated completion date is December 2025.
Optimal Management of Bacillus Calmette-Gurin–Refractory Non–Muscle-Invasive Bladder Cancer in 2023 (e-juo.org)

[Legit62]

What results are those??? Not ours

[Oden6570]

That was my thoughts as well , Compare latest results provided in quarterly , I am always confused now by  the varying way resolts have been presented. I rely only on our stellar results posted recently. Study II Preliminary Clinical Data: To date, Study II has provided the primary study treatment for 63 patients. Performance to Primary, Secondary and Tertiary Objectives Study II

[Eoganacht]

Those are our results but they're old. They're from Aug. 29 2022.

[riverrrow]

The CR at 450 days clearly looks like a misquote.  Accidental or.....?  Once these things are out there, it's difficult to recover, even if a formal correction is made.  Is this what's holding trial patient recruitment and TLT share price down???

[riverrrow]

My apologies, the quoted CR at 450 days  is correct but  about half of the 22 patients in that trial group are the underdosed patients.  It would have been better for TLT if their study was not included in this review.