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Theralase to Present Groundbreaking Research at ASTRO 2025

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Theralase Technologies (TLTFF) has announced groundbreaking preclinical results showing that their radiation-activated Rutherrin® treatment is 100 times more effective at destroying cancer cells compared to radiation therapy alone. The company will present these findings at the ASTRO 2025 conference in San Francisco.

Key findings demonstrate that Rutherrin®, a ruthenium-based small molecule drug, shows selective tumor targeting, enhanced blood-brain barrier penetration with 10x higher concentrations in GBM tumors, and combines direct tumor cell destruction with immune activation. The treatment works through Radio Dynamic Therapy (RDT), generating Reactive Oxygen Species for immediate cytotoxicity and Immunogenic Cell Death for durable immune response.

The company plans to complete GLP toxicology studies in 2025 and launch clinical studies in early 2026, targeting GBM, lung, pancreatic, lymphoma, and colorectal cancers.

Theralase Technologies (TLTFF) ha annunciato risultati preclinici rivoluzionari che dimostrano come il loro trattamento attivato da radiazioni Rutherrin® sia 100 volte più efficace nell'eliminare le cellule tumorali rispetto alla sola radioterapia. L'azienda presenterà questi risultati alla conferenza ASTRO 2025 a San Francisco.

I risultati chiave evidenziano che Rutherrin®, un farmaco a piccola molecola a base di rutenio, mostra un targeting selettivo del tumore, una maggiore penetrazione della barriera emato-encefalica con concentrazioni 10 volte superiori nei tumori GBM, e combina la distruzione diretta delle cellule tumorali con l'attivazione del sistema immunitario. Il trattamento agisce tramite la Radio Dynamic Therapy (RDT), generando specie reattive dell'ossigeno per una citotossicità immediata e la morte cellulare immunogenica per una risposta immunitaria duratura.

L'azienda prevede di completare gli studi tossicologici GLP nel 2025 e di avviare studi clinici all'inizio del 2026, con l'obiettivo di trattare tumori GBM, polmonari, pancreatici, linfomi e del colon-retto.

Theralase Technologies (TLTFF) ha anunciado resultados preclínicos innovadores que demuestran que su tratamiento activado por radiación Rutherrin® es 100 veces más efectivo para destruir células cancerosas en comparación con la radioterapia sola. La empresa presentará estos hallazgos en la conferencia ASTRO 2025 en San Francisco.

Los hallazgos clave muestran que Rutherrin®, un fármaco de pequeña molécula basado en rutenio, presenta una selectividad en la localización tumoral, una penetración mejorada de la barrera hematoencefálica con concentraciones 10 veces mayores en tumores GBM, y combina la destrucción directa de células tumorales con la activación inmune. El tratamiento funciona mediante la Terapia Dinámica por Radio (RDT), generando Especies Reactivas de Oxígeno para citotoxicidad inmediata y Muerte Celular Inmunogénica para una respuesta inmune duradera.

La compañía planea completar estudios toxicológicos GLP en 2025 y lanzar estudios clínicos a principios de 2026, apuntando a cánceres de GBM, pulmón, páncreas, linfoma y colorrectal.

Theralase Technologies (TLTFF)는 방사선 활성화 Rutherrin® 치료법이 단독 방사선 치료에 비해 암세포 파괴 효과가 100배 더 뛰어나다는 획기적인 전임상 결과를 발표했습니다. 회사는 이 결과를 샌프란시스코에서 열리는 ASTRO 2025 학회에서 발표할 예정입니다.

주요 발견 사항에 따르면, 루테늄 기반의 소분자 약물인 Rutherrin®은 종양 선택적 표적화, 뇌혈관장벽 투과력 강화로 GBM 종양 내 10배 더 높은 농도를 보이며, 종양 세포 직접 파괴와 면역 활성화를 결합합니다. 이 치료법은 방사선 동적 치료(RDT)를 통해 반응성 산소종을 생성하여 즉각적인 세포독성과 지속적인 면역 반응을 유도하는 면역원성 세포사를 일으킵니다.

회사는 2025년에 GLP 독성학 연구를 완료하고 2026년 초에 임상 시험을 시작할 계획이며, GBM, 폐암, 췌장암, 림프종 및 대장암을 대상으로 합니다.

Theralase Technologies (TLTFF) a annoncé des résultats précliniques révolutionnaires montrant que leur traitement activé par radiation Rutherrin® est 100 fois plus efficace pour détruire les cellules cancéreuses comparé à la radiothérapie seule. La société présentera ces résultats lors de la conférence ASTRO 2025 à San Francisco.

Les résultats clés démontrent que Rutherrin®, un médicament à petite molécule à base de ruthénium, présente un ciblage tumoral sélectif, une meilleure pénétration de la barrière hémato-encéphalique avec des concentrations 10 fois supérieures dans les tumeurs GBM, et combine la destruction directe des cellules tumorales avec l’activation du système immunitaire. Le traitement agit par Thérapie Dynamique par Radio (RDT), générant des espèces réactives de l’oxygène pour une cytotoxicité immédiate et une mort cellulaire immunogénique pour une réponse immunitaire durable.

La société prévoit de terminer les études toxicologiques GLP en 2025 et de lancer les essais cliniques début 2026, ciblant les cancers GBM, du poumon, du pancréas, du lymphome et colorectal.

Theralase Technologies (TLTFF) hat bahnbrechende präklinische Ergebnisse bekannt gegeben, die zeigen, dass ihre strahlenaktivierte Rutherrin®-Behandlung 100-mal effektiver bei der Zerstörung von Krebszellen ist als die alleinige Strahlentherapie. Das Unternehmen wird diese Erkenntnisse auf der ASTRO 2025-Konferenz in San Francisco präsentieren.

Wesentliche Ergebnisse zeigen, dass Rutherrin®, ein rutheniumbasiertes niedermolekulares Medikament, eine selektive Tumorzielsteuerung, eine verbesserte Überwindung der Blut-Hirn-Schranke mit 10-fach höheren Konzentrationen in GBM-Tumoren aufweist und die direkte Tumorzellzerstörung mit Immunaktivierung kombiniert. Die Behandlung wirkt durch Radio Dynamic Therapy (RDT), die reaktive Sauerstoffspezies erzeugt für sofortige Zytotoxizität und immunogene Zellsterblichkeit für eine nachhaltige Immunantwort.

Das Unternehmen plant, die GLP-Toxikologiestudien 2025 abzuschließen und Anfang 2026 klinische Studien zu starten, mit Fokus auf GBM, Lungen-, Bauchspeicheldrüsen-, Lymphom- und Darmkrebs.

Positive
  • Preclinical results show 100x more effectiveness in destroying cancer cells compared to radiation alone
  • Demonstrated 10x higher concentration in brain tumors vs healthy tissue, showing selective targeting
  • Treatment shows potential for multiple cancer types (GBM, lung, pancreatic, lymphoma, colorectal)
  • Clear development timeline with GLP toxicology studies in 2025 and clinical studies in early 2026
Negative
  • Still in preclinical stage, with clinical trials not starting until 2026
  • Results are from preclinical models only, human efficacy yet to be proven

Radiation-Activated Rutherrin(R) Shown to Be 100 Times More Effective Than Radiation Alone in Preclinical Cancer Models

Toronto, Ontario--(Newsfile Corp. - May 28, 2025) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company pioneering light, radiation, sound and drug-activated therapeutics for the treatment of cancer, bacteria and viruses is proud to announce promising new preclinical results. The Company's latest research demonstrates that radiation-activated Rutherrin® is up to 100 times more effective at destroying cancer cells than radiation therapy alone in comparable models.

This data will be showcased at the 2025 American Society for Radiation Oncology ("ASTRO") 67th Annual Meeting, the world's largest gathering of radiation oncology professionals, taking place in late September in San Francisco, California. ASTRO has selected the Theralase® abstract titled, "Rutherrin® Activated by Radiation Therapy Induces Synergistic Tumor Regression through Direct Destruction and Immune Activation in Multiple Preclinical Cancer Models", for presentation in a scientific poster session.

The study highlights the potent anti-cancer effects of Rutherrin®—a ruthenium-based small molecule drug formulated with recombinant human transferrin for intravenous administration. Once activated by ionizing radiation through a process known as Radio Dynamic Therapy ("RDT"), Rutherrin® initiates a two-phase cancer-killing response: the generation of Reactive Oxygen Species ("ROS") for immediate cytotoxicity, followed by Immunogenic Cell Death ("ICD") to stimulate a durable immune response.

Key Findings from the Preclinical Research:

  • Selective Tumor Targeting: Rutherrin® preferentially accumulates in tumor tissues, sparing healthy cells.

  • Blood-Brain Barrier Penetration: Demonstrated 10x higher concentrations in Glio Blastoma Multiforme ("GBM") tumors than in healthy brain tissue.

  • Synergistic Mechanism: Combines direct tumor cell destruction with robust immune activation.

  • Improved Survival Rates: Statistically significant survival benefits compared to radiation therapy alone.

  • Resistance Overcoming: Effectively inhibits mechanisms associated with multidrug and radiation resistance.

  • Adaptive Immune Activation: Induces long-term immunity, as evidenced by resistance to tumor rechallenge.

Mark Roufaiel, Ph.D., research scientist at Theralase® commented, "These results are highly encouraging. Rutherrin® not only enhances the effectiveness of radiation therapy, but also activates a sustained immune response, offering a powerful, dual-action strategy against aggressive and treatment-resistant cancers."

Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer of Theralase®, added, "Our focus is to bring this innovative platform to clinical application. Rutherrin® represents a major advancement in oncologic treatment, potentially enabling radiation oncologists to dramatically improve patient outcomes. This research provides a strong foundation for integrating Rutherrin® with existing cancer therapies to deliver more effective, long-lasting solutions."

Roger DuMoulin-White, B.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer of Theralase®, stated, "Based on this compelling data, we are fully committed to completing GLP toxicology studies in 2025. This critical milestone will support the launch of clinical studies in early 2026 targeting GBM, lung, pancreatic, lymphoma and colorectal cancers. We're excited to continue advancing Rutherrin® toward commercialization and transforming cancer care."

About ASTRO

Founded in 1958, ASTRO's mission is to advance the practice of radiation oncology by promoting excellence in patient care, providing opportunities for educational and professional development, promoting research, disseminating research results and representing radiation oncology in a rapidly evolving health care environment.

The ASTRO Annual Meeting is the premier event in radiation oncology, bringing together leading scientists, clinicians and industry partners to share groundbreaking research and technological innovations. The 2025 meeting in San Francisco will showcase cutting-edge advances in radiation biology, translational medicine and cancer therapeutics.

About Rutherrin®

Rutherrin® is a patented formulation of Theralase®'s lead ruthenium-based small molecule (Ruvidar®) combined with recombinant human transferrin making it suitable for intravenous delivery. It has the ability to selectively accumulate in cancer cells versus healthy cells and when radiation-activated provide a one-two punch to cancer, by first destroying the cancer cell through oxidative stress and then activating the immune system for destruction of residual cancer cells. Rutherrin® is slated to enter clinical studies in early 2026 for the destruction of deadly cancers; including: brain, lung, pancreatic, colorectal and lymphoma.

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 associated formulations, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses, with minimal impact on surrounding healthy tissue.

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 the regulatory approvals 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)
416.699.LASE (5273)
www.theralase.com

Kristina Hachey, CPA
Chief Financial Officer X 224
khachey@theralase.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/253568

FAQ

What are the key findings of Theralase's (TLTFF) Rutherrin cancer treatment research?

Theralase's Rutherrin treatment showed 100x greater effectiveness than radiation alone, with 10x higher concentration in brain tumors, selective tumor targeting, and dual-action mechanism combining direct tumor destruction with immune activation.

When will Theralase (TLTFF) begin clinical trials for Rutherrin?

Theralase plans to complete GLP toxicology studies in 2025 and begin clinical trials in early 2026 for GBM, lung, pancreatic, lymphoma, and colorectal cancers.

How does Theralase's (TLTFF) Rutherrin treatment work?

Rutherrin is activated by radiation therapy (RDT), generating Reactive Oxygen Species for immediate cancer cell destruction and triggering Immunogenic Cell Death for a lasting immune response.

Which types of cancer will Theralase (TLTFF) target with Rutherrin?

Theralase plans to target Glioblastoma Multiforme (GBM), lung cancer, pancreatic cancer, lymphoma, and colorectal cancer in their clinical studies.

Where will Theralase (TLTFF) present their Rutherrin research findings?

Theralase will present their research at the 2025 American Society for Radiation Oncology (ASTRO) 67th Annual Meeting in San Francisco.
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