Ruvidar Demonstrates 7 Year Complete Response
Theralase Technologies (TLTFF) has announced a significant breakthrough in treating BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). A patient diagnosed with Carcinoma In-Situ (CIS) has maintained a Complete Response for over 7 years following a single treatment with their light-activated RuvidarTM therapy.
The treatment involved administering Theralase's lead molecule RuvidarTM, activated by the TLC-3200 medical laser system. CIS, found in about 10% of bladder cancer cases, is an aggressive form of NMIBC with high recurrence rates. The company plans to complete its Phase II NMIBC clinical study in 2025, followed by regulatory submissions to Health Canada and FDA in 2026.
The company is also exploring RuvidarTM's potential applications in treating various conditions, from herpes simplex virus lesions to aggressive cancers like glioblastoma multiforme, non-small cell lung cancer, pancreatic cancer, and Muscle Invasive Bladder Cancer.
Theralase Technologies (TLTFF) ha annunciato un'importante scoperta nel trattamento del Carcinoma Vescicale Non Muscolo Invasivo Non Rispondente al BCG (NMIBC). Un paziente diagnosticato con Carcinoma In-Situ (CIS) ha mantenuto una Risposta Completa per oltre 7 anni dopo un singolo trattamento con la loro terapia attivata dalla luce RuvidarTM.
Il trattamento ha comportato l'amministrazione della molecola principale di Theralase, RuvidarTM, attivata dal sistema laser medico TLC-3200. Il CIS, presente in circa il 10% dei casi di cancro alla vescica, è una forma aggressiva di NMIBC con alte percentuali di recidiva. L'azienda prevede di completare il suo studio clinico di Fase II per NMIBC nel 2025, seguito da sottomissioni regolatorie a Salute Canada e FDA nel 2026.
L'azienda sta anche esplorando le potenziali applicazioni di RuvidarTM nel trattamento di varie condizioni, dalle lesioni del virus herpes simplex a tumori aggressivi come il glioblastoma multiforme, il cancro polmonare non a piccole cellule, il cancro pancreatico e il Cancro Vescicale Muscolo Invasivo.
Theralase Technologies (TLTFF) ha anunciado un avance significativo en el tratamiento del Cáncer de Vejiga No Invasivo Muscular No Responsable al BCG (NMIBC). Un paciente diagnosticado con Carcinoma In-Situ (CIS) ha mantenido una Respuesta Completa durante más de 7 años tras un único tratamiento con su terapia activada por luz RuvidarTM.
El tratamiento consistió en administrar la molécula principal de Theralase, RuvidarTM, activada por el sistema láser médico TLC-3200. El CIS, encontrado en aproximadamente el 10% de los casos de cáncer de vejiga, es una forma agresiva de NMIBC con altas tasas de recurrencia. La empresa planea completar su estudio clínico de Fase II para NMIBC en 2025, seguido de presentaciones regulatorias a Salud Canadá y la FDA en 2026.
La empresa también está explorando las posibles aplicaciones de RuvidarTM en el tratamiento de diversas condiciones, desde lesiones del virus del herpes simple hasta cánceres agresivos como el glioblastoma multiforme, el cáncer de pulmón no de células pequeñas, el cáncer de páncreas y el Cáncer de Vejiga Invasivo Muscular.
Theralase Technologies (TLTFF)는 BCG 비반응성 비근육 침습성 방광암 (NMIBC) 치료에서 중요한 돌파구를 발표했습니다. Carcinoma In-Situ (CIS)로 진단된 환자가 RuvidarTM 광활성 치료로 단일 치료 후 7년 이상 완전 반응을 유지하고 있습니다.
치료에는 Theralase의 주요 분자인 RuvidarTM을 TLC-3200 의료 레이저 시스템으로 활성화하여 투여했습니다. CIS는 방광암 사례의 약 10%에서 발견되는 공격적인 형태의 NMIBC로, 재발률이 높습니다. 이 회사는 2025년 NMIBC 임상 연구 2상 완료를 계획하고 있으며, 2026년에는 캐나다 보건부와 FDA에 규제 제출을 할 예정입니다.
회사는 또한 RuvidarTM의 다양한 조건 치료에 대한 잠재적 응용 가능성을 탐색하고 있으며, 단순 포진 바이러스 병변에서부터 교모세포종, 비소세포 폐암, 췌장암 및 근육 침습성 방광암과 같은 공격적인 암까지 포함됩니다.
Theralase Technologies (TLTFF) a annoncé une avancée significative dans le traitement du Cancer de la Vessie Non Invasif Musculaire Non Répondant au BCG (NMIBC). Un patient diagnostiqué avec un Carcinome In-Situ (CIS) a maintenu une Réponse Complète pendant plus de 7 ans après un traitement unique avec leur thérapie activée par la lumière RuvidarTM.
Le traitement a consisté à administrer la molécule principale de Theralase, RuvidarTM, activée par le système laser médical TLC-3200. Le CIS, trouvé dans environ 10 % des cas de cancer de la vessie, est une forme agressive de NMIBC avec des taux de récidive élevés. L'entreprise prévoit de compléter son étude clinique de Phase II sur le NMIBC en 2025, suivie de soumissions réglementaires à Santé Canada et à la FDA en 2026.
L'entreprise explore également les applications potentielles de RuvidarTM dans le traitement de diverses conditions, allant des lésions du virus herpès simplex aux cancers agressifs comme le glioblastome multiforme, le cancer du poumon non à petites cellules, le cancer du pancréas et le Cancer de la Vessie Invasif Musculaire.
Theralase Technologies (TLTFF) hat einen bedeutenden Durchbruch bei der Behandlung von BCG-Resistentem Nicht-Muskel-Invasivem Blasenkarzinom (NMIBC) bekannt gegeben. Ein Patient, bei dem Carcinoma In-Situ (CIS) diagnostiziert wurde, hat nach einer einzigen Behandlung mit ihrer lichtaktivierten RuvidarTM-Therapie über 7 Jahre eine Vollständige Reaktion aufrechterhalten.
Die Behandlung umfasste die Verabreichung des Hauptmoleküls von Theralase, RuvidarTM, das durch das medizinische Lasergerät TLC-3200 aktiviert wurde. CIS, das in etwa 10 % der Blasenkarzinomfälle vorkommt, ist eine aggressive Form von NMIBC mit hohen Rückfallquoten. Das Unternehmen plant, seine Phase-II-Studie zu NMIBC im Jahr 2025 abzuschließen, gefolgt von regulatorischen Einreichungen bei Health Canada und der FDA im Jahr 2026.
Das Unternehmen untersucht auch die potenziellen Anwendungen von RuvidarTM zur Behandlung verschiedener Erkrankungen, von Herpes-simplex-Virusläsionen bis hin zu aggressiven Krebserkrankungen wie Glioblastom, nicht-kleinzelligem Lungenkrebs, Pankreaskrebs und muskelinvasivem Blasenkarzinom.
- Single patient showed 7-year complete response after just one treatment
- Phase II NMIBC clinical study completion expected in 2025
- Regulatory submissions planned for 2026
- Potential expansion into multiple cancer and viral infection treatments
- Results to single patient case study
- Regulatory approval still pending
- Phase II study results not yet available
Patient Diagnosed with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ Treated Once with Light-Activated Ruvidar(TM) Demonstrates 7 Year Complete Response
Toronto, Ontario--(Newsfile Corp. - April 7, 2025) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), 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 pleased to announce that a patient enrolled in the Phase Ib Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study (A Phase 1b Clinical Study of Intravesical Photodynamic Therapy in Patients with Bacillus Calmette-Guérin-unresponsive Non-muscle-invasive Bladder Cancer - ScienceDirect) has demonstrated a sustained Complete Response ("CR") (negative cystoscopy and negative urine cytology) lasting over 7 years. The patient was diagnosed with Bacillus Calmette-Guérin ("BCG")-Unresponsive NMIBC Carcinoma In-Situ ("CIS") and was treated once with the therapeutic dose of Theralase®'s lead small molecule RuvidarTM, which was subsequently activated with the TLC-3200 medical laser system.
CIS of the bladder is an aggressive type of NMIBC characterized as a flat, high-grade tumour confined to the urothelial layer. NMIBC comprises approximately
Management of CIS of the bladder remains a complex and challenging endeavor due to its high rate of recurrence and progression. Although it is typically grouped with other NMIBCs, its higher grade and aggressiveness make it a unique clinical entity. Intravesical BCG is the standard first-line treatment given its superiority to other agents; however, high rates of BCG failure highlight the need for additional therapies.2
CIS in the bladder is associated with a less favourable prognosis. It is more likely to recur after treatment. There is also a greater risk of CIS developing into Muscle Invasive Bladder Cancer ("MIBC").3
Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer, Theralase® stated, "As a physician and a scientific researcher, I am delighted that this patient was able to achieve and maintain a complete response for 7 years after only 1 treatment. BCG-Unresponsive NMIBC CIS is a difficult to treat disease, with a very high probability of recurrence and progression. Theralase®'s light-activated Ruvidar® small molecule, based on my team's preclinical research, is able to destroy cancer through the production of reactive oxygen species and subsequently prevent its recurrence through the activation of the immune system."
Roger DuMoulin-White, B.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer, Theralase® stated, "RuvidarTM has certainly proven to be a versatile small molecule, with its ability to destroy cancer, bacteria and viruses, when activated by light, radiation, sound or even other drugs. I am excited that it has now been proven to be safe and effective in BCG-Unresponsive NMIBC CIS for over 7 years, a very difficult to treat condition. As Theralase® wraps up the Phase II NMIBC clinical study in 2025 with a Health Canada and FDA regulatory submission in 2026, I look forward to working with our world-class scientists, researchers and medical doctors in the commencement of numerous new clinical studies, focused on hard to treat viral infections, such as herpes simplex virus lesions (cold sores), through to some of the deadliest and most difficult to treat cancers in the world, such as: glioblastoma multiforme, non-small cell lung cancer, pancreatic cancer and MIBC."
1 Llano A, Chan A, Kuk C, Kassouf W, Zlotta AR. Carcinoma In Situ (CIS): Is There a Difference in Efficacy between Various BCG Strains? A Comprehensive Review of the Literature. Cancers (Basel). 2024 Jan 5;16(2):245. doi: 10.3390/cancers16020245. PMID: 38254736; PMCID: PMC10813486.
2 Tang DH, Chang SS. Management of carcinoma in situ of the bladder: best practice and recent developments. Ther Adv Urol. 2015 Dec;7(6):351-64. doi: 10.1177/1756287215599694. PMID: 26622320; PMCID: PMC4647140.
3 Prognosis and survival for bladder cancer | Canadian Cancer Society.
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 molecule 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.
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 ("FLS") 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 small molecules and their drug formulations. FLS 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 the Company's management regarding future research, development and commercialization of the Company's small molecules; 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 fund and secure regulatory approval to successfully complete various clinical studies in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its small molecule and drug formulations; the risk that access to sufficient capital to fund the Company's operations may not be available on terms that are commercially favorable to the Company or at all; the risk that the Company's small molecule and drug formulations may not be effective against the diseases tested in its clinical studies; the risk that the Company fails to comply with the terms 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 FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the FLS.
Although the FLS 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 FLS.
All FLS 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 FLS.
For investor information on the Company, please feel to reach out Investor Inquiries - Theralase Technologies.
For More Information:
1.866.THE.LASE (843-5273)
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Kristina Hachey, CPA
Chief Financial Officer X 224
khachey@theralase.com
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FAQ
What results did TLTFF achieve in their BCG-Unresponsive NMIBC treatment?
When will Theralase (TLTFF) submit regulatory applications for RuvidarTM?
What is the success rate of RuvidarTM in treating bladder cancer CIS?
What other conditions is TLTFF targeting with RuvidarTM treatment?
