Theralase Technologies Inc (TSX-V:TLT, OTCQB:TLTFF) announced that Dr Michael Jewett has joined the company as an independent consultant to assist it in completing patient enrollment for its Phase 2 clinical study evaluating its photodynamic therapy technology for Bacillus Calmette-Guérin-unresponsive non muscle invasive bladder cancer carcinoma in situ.
Dr Jewett brings extensive oncology experience, including having been appointed to the Order of Canada in December 2020 for his innovations in surgical oncology and advocacy for patient-centered clinical care.
The company said that Dr Jewett will work with the existing clinical study sites and help onboard new sites to complete the enrollment in Study 2 and provide the primary treatment to all 100 patients ideally by the year-end. Theralase has enrolled 63 patients in the study to date.
The company said that if all 100 patients are enrolled by the end of 2024 or the start of 2025, it will be able to complete the primary follow-up by mid-2026 and then be able to seek potential Health Canada and US Food and Drug Administration (FDA) regulatory approval by the end of 2026 or the start of 2027.
"I am delighted that Michael has accepted to join the company in his new role as an independent consultant to work with the clinical study sites to complete enrollment and provide the primary study treatment to 100 patients in total in Study 2 by the end of 2024,” Theralase CEO Roger Du-Moulin-White said in a statement.
“I strongly believe under Michael's leadership and direction that the company will be able to achieve this strategic objective. I look forward to working with him in his new capacity."
Dr Jewett added that he was delighted to be working with the Theralase team again after his involvement in the Phase 1b clinical study and commencement of the Phase 2 study.
“I strongly believe in the safety and efficacy of the Theralase technology in effectively treating patients diagnosed with Bacillus Calmette-Guérin-unresponsive non muscle invasive bladder cancer carcinoma in situ,” he said.
“The Theralase technology, in a majority of cases, involves only one treatment versus months of therapy with immunotherapy and/or chemotherapy drugs and has only mild to moderate side effects that are easily managed and often resolve in days.”
Theralase is a clinical-stage pharmaceutical company dedicated to the research and development of light-activated compounds, their associated drug formulations and the light systems that activate them, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.