Theralase(R) Interim Clinical Data to be Presented at the 2025 AUA Annual Meeting

Associated Press

27-01-2025

TORONTO, ON / ACCESS Newswire / January 27, 2025 / Theralase® Technologies Inc. ('Theralase®" or the 'Company') (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses is proud to announce that its interim clinical data has been selected for presentation at the American Urological Association ('AUA') Annual Meeting.
The Program Committee of the AUA has accepted the Theralase®'s abstract titled: 'Interim Analysis of Light-Activated TLD-1433 in a Phase II Clinical Study of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ' for presentation in a Podium Session at the 2025 Annual Meeting of the American Urological Association to be held in Las Vegas, Nevada, April 26th to 29th.
The clinical data from Theralase®'s international, multicenter Phase II ('BCG')-Unresponsive Non-Muscle Invasive Bladder Cancer ('NMIBC') Carcinoma In-Situ ('CIS') study will be presented by principal investigator Dr. Girish Kulkarni in an oral presentation.
Pending regulatory approval, this innovative technology represents an opportunity for a significant advancement in bladder cancer treatment, by providing a safe and effective therapy for patients who have exhausted their standard of care therapeutic options and are now facing radical cystectomy (bladder removal).
The interim clinical data supports the high safety and efficacy of the treatment with a number of patients demonstrating a duration of response of 3 years or greater with a single treatment.
These findings support the use of light-activated Ruvidar™ by the urology community to safely and effectively treat patients inflicted with BCG-Unresponsive NMIBC, helping to revolutionize the treatment landscape for bladder cancer.
Girish Kulkarni, MD, PhD, FRCSC, a urologic surgeon in the Department of Surgical Oncology at the Princess Margaret Cancer Centre, University Health Network and Assistant Professor at the University of Toronto, Department of Surgery stated, 'We are excited that our clinical study has been accepted for podium presentation at the American Urological Association. The early data is supportive of light-activated RuvidarTM, as a treatment modality for BCG-Unresponsive CIS of the bladder, thus enabling patients to preserve their bladders and maintain their quality of life.'
Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer, Theralase® stated, 'In the interim clinical data, we have observed a strong safety and efficacy response in bladder cancer patients treated at numerous clinical study sites across Canada and the US. The data supports the use of light-activated Ruvidar™ in the treatment of patients with high-grade, high-risk NMIBC. In addition, the latest results demonstrate a long-lasting duration of complete response induced by this innovative technology, which is able to be completed within a few hours and is suitable for patients with CIS of the urinary bladder, who have not responded to previous therapies and who are currently facing a life-altering option, such as a radical cystectomy.'
Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, Chief Executive Officer, Theralase® stated, 'The acceptance of the Theralase® abstract for podium presentation at the AUA Annual Meeting is a testament to the importance and significant impact that this clinical research could have on the lives of bladder cancer patients. We look forward to the presentation and the continued development of Ruvidar™ for patients in need. Patient enrollment is scheduled to be completed in 2025, with clinical data submission to Health Canada and the FDA in 2026. Pending successful regulatory approval, Theralase® plans to make this technology commercially available to the entire urological community in 2027.'
About the Annual Meeting of the American Urological Association
The AUA Annual Meeting is one of the world's largest gatherings of urological professionals, bringing together leading researchers, clinicians and industry experts to share the latest advancements in urological care and research. The 2025 event in Las Vegas promises to highlight cutting-edge developments in the field, offering a platform for collaboration and innovation.
About Study II:
Study II utilizes the therapeutic dose of the patented Study II Drug ('RuvidarTM' or 'TLD-1433") (0.70 mg/cm2) activated by the proprietary Study II Device (TLC-3200 Medical Laser System or 'TLC-3200"). Study II is focused on enrolling and treating approximately 75 to 100 BCG-Unresponsive NMIBC CIS patients in up to 15 Clinical Study Sites ('CSS') located in Canada and the United States.
About Ruvidar™
Ruvidar™ is a small molecule, able to be activated by light, radiation, sound and/or other drugs, designed to selectively target and destroy cancer cells, while minimizing damage to surrounding healthy tissue. It represents a novel approach in the treatment of BCG-Unresponsive NMIBC CIS. It is planned to be evaluated in various other cancers in 2025; including: brain, lung, pancreatic and muscle invasive bladder cancer.
About Theralase® Technologies Inc.:
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses.
Additional information is available at www.theralase.com and www.sedarplus.ca
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Forward Looking Statements:
This news release contains 'forward-looking statements' within the meaning of applicable Canadian securities laws. Such statements include; but, are not limited to statements regarding the Company's proposed development plans with respect to Photo Dynamic Compounds and their drug formulations. Forward looking statements may be identified by the use of the words 'may, 'should', 'will', 'anticipates', 'believes', 'plans', 'expects', 'estimate', 'potential for' and similar expressions; including, statements related to the current expectations of Company's management for future research, development and commercialization of the Company's Photo Dynamic Compounds and their drug formulations, preclinical research, clinical studies and regulatory approvals.
These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to: adequately fund and secure the requisite regulatory approvals to commercially market a treatment for bladder cancer in a timely fashion and implement its commercialization strategy. Other risks include: the ability of the Company to successfully complete its Phase II BCG-Unresponsive NMIBC CIS clinical study , access to sufficient capital to fund the Company's operations may not be available or may not be available on terms that are commercially favorable to the Company, the Company's drug formulations may not be effective against the diseases tested in its clinical studies, the Company's fails to comply with the term of license agreements with third parties and as a result loses the right to use key intellectual property in its business, the Company's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company's ability to control or predict.
Readers should not unduly rely on these forward- looking statements, which are not a guarantee of future performance. There can be no assurance that forward looking statements will prove to be accurate as such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements.
Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements.
All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such statements.