- Pharma stock Theralase Technologies (TSXV:TLT) announced a significant update on its ongoing bladder cancer clinical study
- The company’s lead drug, Ruvidar is under investigation in a Phase II registration study for Bacillus Calmette-Guérin (BCG)-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
- With bladder cancer being the fourth leading cancer in men in 2023, representing 6 percent of new cancer cases and 4 per cent of cancer-related deaths, the demand for innovative treatments is high
- Theralase stock (TSXV:TLT) opened trading at $0.18 per share
Pharma stock Theralase Technologies (TSXV:TLT) announced a significant update on its ongoing bladder cancer clinical study.
The clinical-stage pharmaceutical company’s lead drug, Ruvidar, activated by the TLC-3200 Medical Laser System, is currently under investigation in a Phase II registration study for Bacillus Calmette-Guérin (BCG)-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Carcinoma In-Situ (CIS) with or without resected Ta/T1 papillary disease.
Key highlights of the update:
- Patient enrollment and study sites: The study has enrolled 75 patients across 10 clinical sites in North America, with five sites in Canada and five in the United States.
- Study procedure: Patients receive an intravesical installation of reconstituted Ruvidar for approximately 60 minutes, activated by the TLC-3200 for another 60 minutes.
- Efficacy and safety: The primary objective is to determine initial efficacy, measured by complete response rates at various intervals. Patients are assessed at 90, 180, 270, 360 and 450 days, with extended follow-ups at 540, 630, 720, 900 and 1,080 days.
- Regulatory compliance: The study is designed in compliance with the FDA’s guidance for BCG-Unresponsive NMIBC, highlighting the critical need for effective bladder-sparing therapies.
Market implications:
The positive interim results from this study could position Theralase as a key player in the bladder cancer treatment market.
According to recent data from the American Cancer Society, in the United States, an estimated 83,190 patients will be diagnosed with bladder cancer this year.
With bladder cancer being the fourth leading cancer in men in 2023, representing 6 per cent of new cancer cases and 4 per cent of cancer-related deaths, the demand for innovative treatments is high. The company’s progress in this clinical study could attract significant investor interest and potentially lead to strategic partnerships or funding opportunities.
Leadership insights
“I am pleased by the latest clinical data supporting 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 per cent and if left untreated, an ability to progress to MIBC at a 40 per cent to 80 per cent rate within five years,” Theralase’s chief scientific officer, Arkady Mandel, M.D., Ph.D., D.Sc., said in a news release. “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 more than 3 years, after a single study procedure.”
“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. 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,” Theralase’s president and chief executive officer, Roger DuMoulin-White, B.E.Sc., P.Eng., Pro.Dir., added. “As Theralase completes enrollment in its clinical study, this year and into the beginning of next year, Theralase is actively seeking partnering/licensing opportunities for various geographical territories around the world in the commercialization of Ruvidar for the treatment of BCG-Unresponsive NMIBC.”
About Theralase
Theralase is developing light and/or radiation-activated compounds, associated drug formulations and the light systems that activate them to destroy various cancers, bacteria and viruses.
Theralase stock (TSXV:TLT) opened trading at $0.18 per share and has risen 2.86 per cent since the beginning of the year.
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(Top photo: Theralase Technologies)