Theralase(R) Interim Clinical Data to be Presented at the 2025 AUA Annual Meeting
Theralase Technologies (TSXV:TLT)(OTCQB:TLTFF) announced that its interim clinical data has been selected for presentation at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas. The presentation will focus on their Phase II clinical study of light-activated TLD-1433 for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer.
The interim data shows promising safety and efficacy results, with some patients demonstrating a duration of response of 3+ years following a single treatment. The innovative Ruvidar™ technology aims to provide an alternative to radical cystectomy for patients who have exhausted standard treatment options.
The company plans to complete patient enrollment in 2025, submit clinical data to Health Canada and FDA in 2026, and aims for commercial availability by 2027, pending regulatory approval.
Theralase Technologies (TSXV:TLT)(OTCQB:TLTFF) ha annunciato che i dati clinici provvisori sono stati selezionati per la presentazione al 2025 American Urological Association (AUA) Annual Meeting a Las Vegas. La presentazione si concentrerà sullo studio clinico di Fase II dell'TLD-1433 attivato dalla luce per il cancro alla vescica non muscolo-invasive resistente al BCG.
I dati provvisori mostrano risultati promettenti in termini di sicurezza ed efficacia, con alcuni pazienti che dimostrano una durata della risposta superiore a 3 anni dopo un unico trattamento. L'innovativa tecnologia Ruvidar™ mira a fornire un'alternativa alla cistectomia radicale per i pazienti che hanno esaurito le opzioni di trattamento standard.
L'azienda prevede di completare l'arruolamento dei pazienti nel 2025, presentare i dati clinici a Health Canada e alla FDA nel 2026, e punta alla disponibilità commerciale entro il 2027, in attesa dell'approvazione normativa.
Theralase Technologies (TSXV:TLT)(OTCQB:TLTFF) anunció que sus datos clínicos interinos han sido seleccionados para presentarse en el 2025 American Urological Association (AUA) Annual Meeting en Las Vegas. La presentación se centrará en su estudio clínico de Fase II sobre el TLD-1433 activado por luz para el cáncer de vejiga no musculoinvasivo resistente al BCG.
Los datos interinos muestran resultados prometedores en términos de seguridad y eficacia, con algunos pacientes que demuestran una duración de respuesta de más de 3 años tras un único tratamiento. La innovadora tecnología Ruvidar™ pretende ofrecer una alternativa a la cistectomía radical para los pacientes que han agotado las opciones de tratamiento estándar.
La empresa planea completar la inscripción de pacientes en 2025, presentar datos clínicos a Health Canada y a la FDA en 2026, y apunta a la disponibilidad comercial para 2027, pendiente de aprobación regulatoria.
Theralase Technologies (TSXV:TLT)(OTCQB:TLTFF)는 임상 중간 데이터를 2025 American Urological Association (AUA) Annual Meeting에서 발표하기 위해 선정되었다고 발표했습니다. 발표는 BCG-비반응성 비근육침습성 방광암에 대한 광활성 TLD-1433의 2상 임상 연구에 초점을 맞출 것입니다.
중간 데이터는 일부 환자가 단일 치료 후 3년 이상 반응 기간을 보이는 등 안전성과 효과성에 대한 유망한 결과를 보여줍니다. 혁신적인 Ruvidar™ 기술은 표준 치료 옵션을 소진한 환자에게 근본적인 방광 절제술에 대한 대안을 제공하는 것을 목표로 합니다.
회사는 2025년까지 환자 등록을 완료하고, 2026년에 Health Canada 및 FDA에 임상 데이터를 제출하며, 2027년까지 상업적 가용성을 목표로 하고 있습니다. 이는 규제 승인을 조건으로 합니다.
Theralase Technologies (TSXV:TLT)(OTCQB:TLTFF) a annoncé que ses données cliniques intermédiaires avaient été sélectionnées pour être présentées lors de la 2025 American Urological Association (AUA) Annual Meeting à Las Vegas. La présentation se concentrera sur leur étude clinique de Phase II du TLD-1433 activé par la lumière pour le cancer de la vessie non-muscle-invasif résistant au BCG.
Les données intermédiaires montrent des résultats prometteurs en matière de sécurité et d'efficacité, certains patients ayant présenté une durée de réponse de 3 ans ou plus après un traitement unique. La technologie innovante Ruvidar™ vise à fournir une alternative à la cystectomie radicale pour les patients qui ont épuisé les options de traitement standard.
L'entreprise prévoit de terminer l'inscription des patients en 2025, de soumettre des données cliniques à Santé Canada et à la FDA en 2026, et vise une disponibilité commerciale d'ici 2027, sous réserve de l'approbation réglementaire.
Theralase Technologies (TSXV:TLT)(OTCQB:TLTFF) gab bekannt, dass ihre Zwischenklinischen Daten zur Präsentation auf dem 2025 American Urological Association (AUA) Annual Meeting in Las Vegas ausgewählt wurden. Die Präsentation wird sich auf ihre klinische Phase-II-Studie von lichtaktiviertem TLD-1433 für BCG-resistenten nicht-muskelinvasiven Blasenkrebs konzentrieren.
Die Zwischenanalyse zeigt vielversprechende Sicherheits- und Wirksamkeitsdaten, wobei einige Patienten eine Ansprechdauer von über 3 Jahren nach einer Einzeltherapie zeigen. Die innovative Technologie Ruvidar™ zielt darauf ab, eine Alternative zur radikalen Zystektomie für Patienten zu bieten, die alle Standardbehandlungsoptionen erschöpft haben.
Das Unternehmen plant, die Patientenrekrutierung bis 2025 abzuschließen, klinische Daten 2026 bei Health Canada und der FDA einzureichen und strebt an, 2027 kommerziell verfügbar zu sein, vorbehaltlich der regulatorischen Genehmigung.
- Interim clinical data shows high safety and efficacy with 3+ year response duration from single treatment
- Selected for prestigious podium presentation at 2025 AUA Annual Meeting
- Clear commercialization timeline with regulatory submissions planned for 2026
- Technology offers alternative to radical cystectomy for treatment-resistant patients
- Commercial availability not expected until 2027, pending regulatory approval
- Patient enrollment still ongoing and not completed
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
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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.
For investor information on the Company, please feel to reach out Investor Inquiries - Theralase Technologies.
For More Information:
1.866.THE.LASE (843-5273)
416.699.LASE (5273)
www.theralase.com
Kristina Hachey, CPA x224
Chief Financial Officer
khachey@theralase.com
SOURCE: Theralase Technologies, Inc.
View the original press release on ACCESS Newswire
FAQ
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