Theralase Technologies Inc (TSX-V:TLT, OTCQB:TLTFF) has provided an update on its ongoing bladder cancer clinical study involving Ruvidar, its light-activated drug, which is being investigated for Bacillus Calmette-Guérin (BCG)-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC).
This Phase 2 trial, conducted in Canada and the US, is evaluating Ruvidar in combination with the TLC-3200 Medical Laser System.
The study has enrolled 75 patients, with 68 patients evaluated so far.
An interim analysis of the study data showed that the primary objective of the study, complete response (CR) at any point, was achieved by 60.3% of patients, exceeding the 50% benchmark set by international guidelines.
For the secondary objective, 26.5% of patients maintained a CR at 450 days.
The study also demonstrated promising long-term efficacy, with some patients sustaining CR for up to 1,080 days.
The total response rate, which includes both complete and indeterminate responses, was 72.1%.
Safety outcomes indicated 15 serious adverse events, none of which were directly related to the drug or laser device.
The interim analysis shows that Ruvidar provides effective and bladder-sparing treatment for BCG-Unresponsive NMIBC with a favorable safety profile.
As the study progresses, Theralase continues to seek licensing and partnership opportunities to commercialize Ruvidar globally.
"This latest update on our bladder cancer clinical study continues to strengthen our understanding of the potency of Ruvidar in the destruction of bladder cancer,” Theralase CEO Roger DuMoulin-White commented.
“It is a very effective drug and when activated by laser light, even more effective, providing both high efficacy and a high safety profile for patients.”
Dr Arkady Mandel, Theralase's chief scientific officer, also welcomed that data, which supports the application of light-activated Ruvidar in the destruction of bladder cancer.
“BCG-Unresponsive NMIBC CIS is an extremely difficult subset of bladder cancer to treat, with five-year progression rate of 50% and if left untreated, an ability to progress to MIBC at a 40 to 80% rate within five years,” Mandel said.
“The Theralase technology has been proven to provide an opportunity for these patients to maintain their quality of life, through retention of their bladders for ≥ 3 years, after a single Study Procedure.”