Theralase Technologies Inc (TSX-V:TLT, OTCQB:TLTFF) continued to advance its lead asset, bladder cancer treatment Rudivar, in the first quarter of 2024.
The firm is evaluating Rudivar activated by a proprietary device in the Study II clinical trial, which is focused on enrolling and treating approximately 100 patients with Bacillus Calmette Guerin (BCG)-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Carcinoma In-Situ (CIS).
During Q1, the company added Dr Michael Jewett as an independent consultant to assist in bringing on new clinical study sites for Study II.
To date, Study II has provided the primary study treatment to 68 patients with new patients to be enrolled in the second quarter of 2024, Theralase said.
The company added that it is working to add up to five clinical study sites in 2024 and increase enrollment at the existing 10 sites to complete Study II accruement by the end of 2024.
Theralase chief scientific officer Dr Arkady Mandel said the interim clinical study data from Study II to date has proven to be “world-class.”
“Study II has demonstrated an ability to destroy urothelial cell carcinoma in a patient's bladder for a total response of 71% and a duration of that total response of 36%, for patients treated with the optimized Study Procedure,” Dr Mandel said.
“The primary benefits of the Theralase technology versus competitive technologies are the: urologist-led treatment, single out-patient treatment, high efficacy rates, high duration of response and high safety margin, therefore, the Theralase technology presents a safe, effective alternative therapy for patients, who are at risk of having their bladder removed.”
For the three months ended March 31, 2024, the company narrowed its net loss by 10% year-over-year from about C$1.41 million to C$1.27 million.
The decrease in net loss was attributed to decreased spending on research and development expenses in Study II.
Revenue was about C$176,000, compared to about C$207,000 in the year-ago quarter.
Theralase is a clinical-stage pharmaceutical company dedicated to the research and development of light and/or radiation activated Photo Dynamic Compounds for the safe and effective destruction of various cancers, bacteria and viruses.