Theralase Technologies Inc (TSX-V:TLT, OTCQB:TLTFF) recently announced significant progress in the company's bladder cancer clinical study, now involving 72 patients, with expectations to reach 85 by year-end.
CEO Roger Dumoulin-White spoke with Proactive about the significance of these results for both the FDA and the broader medical community in preventing disease progression, as well as the urgency of nearing completion, especially since a competitor received FDA approval with just 77 patients earlier this year.
Proactive: Could you provide us an update on your bladder cancer clinical study?
Roger Dumoulin-White: We're quite excited. The data is progressing very well. Since our last report, where we had about 64 patients, we have now enrolled and treated approximately 72 patients, with another three expected in the next 4 to 6 weeks, bringing us to around 75. This is exciting because one of our competitors received FDA approval in May of this year with 77 patients.
We are very close to completing the study. We hope to have another ten patients by the end of the year, aiming for a total of about 85. The clinical data has been extremely strong. Our primary objective, according to FDA guidelines, is a complete response. Currently, we are showing about a 63% complete response rate, meaning that two out of three patients with non-muscle invasive bladder cancer, carcinoma in situ, BCG-unresponsive, who were considering radical cystectomy, are able to preserve their bladder and maintain their quality of life.
Out of the patients that responded, 44% are experiencing a duration of that response up to 450 days. Interestingly, beyond 450 days, 90% of those patients are continuing to show a complete response, extending to one year, two years, and even three years. This has been fantastic for the patients.
Why is duration of response so important to the FDA?
I believe the duration of response is important to all stakeholders, including regulators like Health Canada and the FDA, insurance companies that cover these services, practitioners and surgeons delivering the treatment, and especially the patients facing this terrible disease. Bladder cancer is challenging to treat, and one of the significant risks is its progression to muscle-invasive cancer. If it breaks out of the bladder, it can spread to the peritoneal cavity and become metastatic, severely diminishing the patient's quality of life and health. Therefore, it's crucial to address it early.
The goal is to eliminate the disease and prevent its recurrence or progression. Both the FDA and Health Canada are very interested in the duration of response. They want to see not only a complete response but also its longevity. Many treatments, including FDA-approved drugs and those under clinical study, start with high effectiveness rates in the 60-70% range, similar to ours, but they often decline rapidly to double or single digits within a year. Our duration of response has been superior to any FDA-approved drugs and shows better results than those reported in clinical studies.
Quotes have been lightly edited for style and clarity