Update on Theralase's Phase II NMIBC Clinical Trial

Theralase Technologies Inc., a pharmaceutical company specializing in the development of Photo Dynamic Compounds (PDCs) for the treatment of various cancers, bacteria, and viruses, has reported progress in its Phase II clinical study for Non-Muscle Invasive Bladder Cancer (NMIBC). The study has treated 63 patients so far, with interim data showing a complete response rate of 64% at the primary assessment, exceeding the International Bladder Cancer Group's (IBCG) guidelines of a 50% response rate at 6 months.

The study's interim results indicate that at 90 days, 56% of patients achieved a complete response, and by 450 days, this rate was sustained at 37%. For patients who received an optimized treatment post-August 1, 2020, the response rates were even higher, with 62% achieving a complete response at 90 days and 39% at 450 days. The data also highlights that 80% of patients remained in the study after the initial treatment, with a significant number maintaining their response over time.

Theralase's PDC, Ruvidar™ (TLD-1433), is activated by the TLC-3200 Medical Laser System and is being tested on approximately 100 BCG-Unresponsive NMIBC Carcinoma In-Situ (CIS) patients across clinical study sites in Canada and the United States. Ruvidar™ has a strong research background, with 12 years of published peer-reviewed preclinical studies.

The company has experienced some serious adverse events (SAEs), with 13 reported during the study. However, Theralase believes these events are unrelated to the study's drug or device. In 2020, the FDA granted Theralase Fast Track Designation for the study, facilitating frequent communication with the FDA to discuss development plans and ensure timely data collection for approval.

Theralase is aiming to complete enrollment and delivery of the primary treatment for all patients in 2024, with the goal of locking clinical data in mid-2026 and potentially receiving Health Canada and FDA approval by 2026/2027. The company is dedicated to researching and developing light-activated compounds for the effective and safe destruction of various diseases.