A xmas message from Theralase
RuvidarTM
Theralase (TSXV:TLT), a clinical-stage pharmaceutical company dedicated to the research and development of light-activated small molecules, is developing a new drug for BCG-Unresponsive NMIBC CIS.
The company’s lead compound, the ruthenium-based molecule TLD-1433 (RuvidarTM), combines with an endogenous (naturally occurring) human glycoprotein in the body, known as transferrin, to become the patented drug, Rutherrin®, a light-activated drug that has demonstrated an ability to kill bladder cancer cells in a pre-clinical setting with over 99.9% effectiveness.
With an FDA new drug application submission planned in 2026 and potential FDA approval in early 2027, RuvidarTM has strong clinical data, achieving an initial CR of 61.9% and a duration of CR of 43.6% at one year, based on clinical data collected to date. Analyzing the KM Curve estimates, RuvidarTM demonstrated a duration of CR of 53% at one year, 35.8% at two years and 24.9% at three years in its latest phase-II results evaluating 63 patients.
What sets RuvidarTM apart from currently approved drugs and those vying for regulatory approval is its ability to completely destroy bladder cancer in 68.3% of patients (over 2 out of 3) after only one three-hour treatment. This provides a clear advantage to both the patient, who needs to attend each appointment, and the uro-oncologist or medical oncologist who needs to supervise each treatment.
Unlike a few of the drugs discussed here today, urologists can prescribe RuvidarTM across the entire BCG-Unresponsive NMIBC CIS patient population, without screening for the absence of various proteins for fear of a lack of effectiveness. In addition, RuvidarTM is used as a monotherapy (by itself) and does not need to be combined with other drugs to increase its efficacy or duration of response.
Supporting its high safety profile, the company believes that all serious adverse events in the clinical study have been unrelated to RuvidarTM or its proprietary TLC-3200 medical laser activation system.
These benefits have all eyes on Theralase®‘s ongoing phase-II clinical study, which has enrolled 75 patients to date and is on track to complete enrollment in 2025 through the recent launch of additional clinical study sites in Canada and the U.S.
The FDA awarded Theralase® the Fast-Track Designation in 2020, granting the company early and frequent communication with the federal agency. The company expects to complete patient follow-ups in 2026, with FDA and Health Canada regulatory approvals expected in early 2027.
In summary, if you are a patient or know someone diagnosed with BCG-Unresponsive NMIBC CIS, bladder removal is now not the only option on the table, as the latest approved drugs and those in clinical development have steadily increased the duration of CR over the past five years.
Talk to your uro-oncologist about how the drugs we’ve discussed in this article may be applicable to your particular cancer journey.
This is sponsored content issued on behalf of Theralase® Technologies Inc., please see full disclaimer here.
BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma-In-Situ: A Patient's Guide | 2024-12-23 | Investing News | Stockhouse