- Theralase® Technologies Inc. (TLT) provides a positive update on its Phase II Non-Muscle Invasive Bladder Cancer (NMIBC) clinical study
- To date, study II has enrolled and provided the primary treatment to a total of 38 patients
- The study was optimized for bladder volume calculation for administration of the study drug and device volume and treatment time
- Study II proved itself to have effective clinical results for the primary, secondary, and tertiary objectives
- Theralase Technologies Inc. (TLT) is down 30.43 per cent trading at $0.32 per share as of 1:03 p.m. ET
Theralase Technologies (TLT) has provided an update on its Phase II Non-Muscle Invasive Bladder Cancer (NMIBC) clinical study.
Theralase previously completed a successful phase I b NMIBC study which enrolled and administered the primary treatment at the therapeutic dose to three patients. To date, study II has enrolled and provided the primary treatment to another 35 patients.
In 2020, the company optimized the treatment specifically for bladder volume calculation for the administration of the study drug and device volume. It also improved the study device treatment time.
Study II adjusted treatment for patients who received either an improved primary study treatment or optimized maintenance study treatment. It consisted of 23 patients at 90 days, 26 patients at 180 days, and 27 patients at 270, 360 and 450 days.
Of the 38 patients in the entire study II, 44.7 per cent achieved a complete result at 90 days. For the 23 patients who received optimized primary study treatment, 52.2 per cent achieved a complete result at 90 days.
Study II proved itself to have effective clinical results for the primary, secondary, and tertiary objectives.
Dr. Arkady Mandel, CSO and interim CEO of Theralase stated,
“I am encouraged by the clinical results to date, which demonstrate the potential to fill an unmet need for patients diagnosed with BCG-Unresponsive NMIBC…. These patients are facing bladder removal and by delivering them a complete response with a durability lasting up to 15 months post primary study treatment”
Theralase® Technologies Inc. (TLT) is down 30.43 per cent trading at $0.32 per share as of 1:03 p.m. ET.