Proactive reports Theralase updateTheralase provides encouraging interim results for Phase II study on bladder cancer treatment Published: 08:52 15 Jan 2024 EST Nice summary!
Theralase Technologies Inc (TSX-V:TLT, OTCQB:TLTFF) has released interim clinical data for its Phase II non-muscle invasive bladder cancer study indicating complete response rates exceeding International Bladder Cancer Group recommendations at various time points.
The study, designed to evaluate the safety and efficacy of Theralase's proprietary Study II Drug, Ruvidar (TLD-1433), has successfully treated 63 patients to date.
According to the interim clinical data, the primary objective of Study II, achieving a complete response (CR), has been met by 54% of patients at six months, 38% at 12 months, and 37% at 15 months, surpassing the International Bladder Cancer Group recommendations.
Furthermore, for patients receiving the optimized Study II Treatment after August 1, 2020, the interim data reveals a 62% CR at the 90-day mark, reaching 39% at 450 days.
Nearly 64% of evaluable patients achieved a CR on at least one assessment date, meeting the primary objective for Study II. Additionally, 37% of patients achieved CR at each assessment date up to 450 days.
Over 80% of patients remained in Study II after 90 days, with 41% of total response (TR) patients maintaining a response duration of more than 450 days.
Study II aims to enroll and treat approximately 100 BCG-Unresponsive NMIBC Carcinoma In-Situ patients in up to 15 Clinical Study Sites in Canada and the United States.
Having received Fast Track Designation from the FDA in 2020, Theralase aims to leverage this status to potentially secure break through designation, accelerated approval, or priority review, pending successful completion of the ongoing study.
Theralase said it anticipates completing enrollment and delivering primary Study II Treatment for all patients in 2024, with clinical data lock expected by mid-2026 and potential Health Canada and FDA approval by 2026/2027.
Theralase is a clinical-stage pharmaceutical company committed to researching and developing light-activated compounds and their formulations, with the primary objective of efficacy and secondary objective of safety in treating various cancers, bacteria, and viruses.