Theralase, a Canadian drug development company focused on the use of laser technology platforms for clinical applications, will work with an undisclosed trial management organization to find four to six US-based sites for its Phase II non-muscle invasive bladder cancer clinical study.
Currently, the trial management organization is working with 14 potential US sites that are integrated clinical urology practices.
According to Theralase, working with this trial management organization is an imperative step for the company as it onboards its US-based clinical study. The sites will enroll and treat between 25 to 50 patients of the approximate 100 total participants it expects to recruit for the study.
The study began in Canada in April 2019 and currently has one site on board, the University Health Network, which is screening potential patients. Theralase expects to use 20 sites across the US, and Canada in this trial.
According to a spokesperson for Therlase, the trial will examine its drug candidate TLD-1433 for non-muscle invasive bladder cancer (NMIBC) that is unresponsive to Bacillus Calmette Guerin (BCG).
The drug candidate localizes cancer cells and destroys them after being activated by laser light. In a Phase Ib trial, TLD-1433 demonstrated a safety profile with 95% of all adverse events completely resolved.
The spokesperson told us, “The BCG-Unresponsive NMIBC market represents an unmet medical need, as current standard of care for BCG-Unresponsive patients specifies a radical cystectomy of the bladder and associated tissues.”