Independent Research Demonstrates Ruvidar(R) Effective in the Destruction of Herpes Simplex Virus
Theralase Technologies (OTCQB: TLTFF) has announced significant preclinical results for its antiviral candidate Ruvidar in treating Herpes Simplex Virus Type 1 (HSV-1). The peer-reviewed research demonstrates that Ruvidar is more effective than current gold standard treatments Acyclovir and Metformin, even without light activation.
Key findings show that Ruvidar effectively suppresses viral replication in infected cells and prevents infection spread to adjacent cells, while current treatments showed minimal effect post-infection. Notably, Ruvidar proved effective against Acyclovir-resistant HSV-1 mutants. The company plans to commence a Phase I/II adaptive clinical study in 2026 to evaluate Ruvidar's safety and efficacy in treating cold sore lesions.
Theralase Technologies (OTCQB: TLTFF) ha annunciato risultati preclinici significativi per il suo candidato antivirale Ruvidar nel trattamento dell'Herpes Simplex Virus di tipo 1 (HSV-1). La ricerca peer-reviewed dimostra che Ruvidar è più efficace rispetto agli attuali standard di riferimento, Aciclovir e Metformina, anche senza attivazione luminosa.
I principali risultati mostrano che Ruvidar sopprime efficacemente la replicazione virale nelle cellule infette e impedisce la diffusione dell'infezione alle cellule vicine, mentre i trattamenti attuali hanno mostrato un effetto minimo dopo l'infezione. In particolare, Ruvidar ha dimostrato efficacia contro mutanti HSV-1 resistenti all'Aciclovir. L'azienda prevede di avviare nel 2026 uno studio clinico adattivo di fase I/II per valutare la sicurezza e l'efficacia di Ruvidar nel trattamento delle lesioni da herpes labiale.
Theralase Technologies (OTCQB: TLTFF) ha anunciado resultados preclínicos significativos para su candidata antiviral Ruvidar en el tratamiento del virus del herpes simple tipo 1 (VHS-1). La investigación revisada por pares demuestra que Ruvidar es más eficaz que los tratamientos estándar actuales, Aciclovir y Metformina, incluso sin activación con luz.
Los hallazgos clave muestran que Ruvidar suprime eficazmente la replicación viral en las células infectadas y evita la propagación de la infección a las células vecinas, mientras que los tratamientos actuales mostraron un efecto mínimo tras la infección. Notablemente, Ruvidar demostró eficacia contra mutantes de VHS-1 resistentes al Aciclovir. La empresa planea iniciar en 2026 un estudio clínico adaptativo de fase I/II para evaluar la seguridad y eficacia de Ruvidar en el tratamiento de las lesiones por herpes labial.
Theralase Technologies (OTCQB: TLTFF)가 HSV-1 치료를 위한 항바이러스 후보물질 Ruvidar에 대한 중요한 전임상 결과를 발표했습니다. 동료 검토를 거친 연구에 따르면 Ruvidar는 현재의 금표준 치료인 아시클로버(Aciclovir)와 메트포르민보다 더 효과적이며, 빛 활성화 없이도 효과가 있습니다.
주요 결과에 따르면 Ruvidar는 감염된 세포에서 바이러스 복제를 효과적으로 억제하고 인접한 세포로의 감염 확산을 방지하는 반면, 현재 치료법은 감염 후에 미미한 효과를 보였습니다. 특히 Ruvidar는 아시클로버 내성 HSV-1 변이체에도 효과가 있음을 입증했습니다. 회사는 2026년에 Ruvidar의 안전성과 유효성을 평가하기 위한 Phase I/II 적응형 임상시험을 시작해 구순포진 병변의 치료에 대한 적용을 검토할 예정입니다.
Theralase Technologies (OTCQB: TLTFF) a annoncé des résultats précliniques significatifs pour son candidat antiviral Ruvidar dans le traitement du virus de l’herpès simplex de type 1 (HSV-1). La recherche évaluée par les pairs démontre que Ruvidar est plus efficace que les traitements standards actuels, l’Aciclovir et la Métformine, même sans activation lumineuse.
Les résultats clés montrent que Ruvidar réprime efficacement la réplication virale dans les cellules infectées et empêche la propagation de l’infection aux cellules voisines, tandis que les traitements actuels présentent un effet minimal après l’infection. Fait notable, Ruvidar s’est révélé efficace contre des mutants HSV-1 résistants à l’Aciclovir. L’entreprise prévoit de lancer en 2026 une étude clinique adaptative de phase I/II pour évaluer la sécurité et l’efficacité de Ruvidar dans le traitement des lésions d’herpès labial.
Theralase Technologies (OTCQB: TLTFF) hat bedeutende präklinische Ergebnisse für den antiviralen Kandidaten Ruvidar bei der Behandlung des Herpes-simplex-Virus Typ 1 (HSV-1) bekannt gegeben. Die peer-reviewte Forschung zeigt, dass Ruvidar wirksamer ist als die derzeitigen Goldstandard-Behandlungen Aciclovir und Metformin, sogar ohne Lichtaktivierung.
Schlüsselbefunde zeigen, dass Ruvidar die virale Replikation in infizierten Zellen effektiv unterdrückt und die Ausbreitung der Infektion auf benachbarte Zellen verhindert, während aktuelle Behandlungen nach der Infektion nur minimale Wirkung zeigten. Bemerkenswert ist, dass Ruvidar gegen Aciclovir-resistente HSV-1-Mutanten wirksam ist. Das Unternehmen plant, im Jahr 2026 eine adaptive Phase-I/II-Studie zu beginnen, um Sicherheit und Wirksamkeit von Ruvidar bei der Behandlung von Lippenherpesläsionen zu evaluieren.
Theralase Technologies (OTCQB: TLTFF) أعلنت عن نتائج مخبرية مهمة لمرشحها المضاد للفيروسات Ruvidar في علاج فيروس الهربس البسيط من النوع 1 (HSV-1). تشير الأبحاث التي خضعت لمراجعة الأقران إلى أن Ruvidar أكثر فعالية من العلاجات القياسية الحالية الأسيكلوفير وميتفورمين، حتى بدون تفعيل ضوئي.
تُظهر النتائج الرئيسية أن Ruvidar يثبط بشكل فعال تكاثر الفيروس في الخلايا المصابة ويمنع انتشار العدوى إلى الخلايا المجاورة، بينما تظهر العلاجات الحالية تأثيراً ضئيلاً بعد الإصابة. ومن الجدير بالذكر أن Ruvidar ثبتت فعاليته ضد طفرات HSV-1 المقاومة للأسيكلوفير. تخطط الشركة لبدء تجربة سريرية تكيفية من المرحلة I/II في عام 2026 لتقييم أمان وفعالية Ruvidar في علاج آفات القروح البردية.
Theralase Technologies (OTCQB: TLTFF) 宣布其抗病毒候选药 Ruvidar 在治疗单纯疱疹病毒 1 型(HSV-1)方面的显著前临床结果。同行评审的研究表明,Ruvidar 的效果优于当前的金标准治疗 阿昔洛韦 (Aciclovir) 与二甲双胍 (Metformin),即使在未进行光激活的情况下也是如此。
关键信息显示,Ruvidar 能在感染细胞中有效抑制病毒复制,并阻止感染扩散到相邻细胞,而现有治疗在感染后效果有限。值得注意的是,Ruvidar 对 阿昔洛韦耐药的 HSV-1 突变体 也显示出效力。公司计划在 2026 年启动一项 I/II 期自适应临床研究,以评估 Ruvidar 在治疗唇疱疹病变方面的安全性与有效性。
- Superior efficacy compared to current gold standard treatments (Acyclovir and Metformin)
- Effective against Acyclovir-resistant HSV-1 mutants, expanding market potential
- Demonstrates efficacy both with and without light activation, enabling deep tissue applications
- Plans to advance to Phase I/II clinical trials in 2026
- Clinical trials not yet started - still in preclinical stage
- Commercialization timeline uncertain with Phase I/II trials planned for 2026
Toronto, Ontario--(Newsfile Corp. - September 24, 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, announced today the peer-reviewed publication of independent preclinical data demonstrating the superiority of its lead antiviral candidate, Ruvidar®, in the destruction of Herpes Simplex Virus Type 1 ("HSV-1").
The latest preclinical data was published in MDPI - Viruses titled, "Ruvidar®-An Effective Anti-Herpes Simplex Virus Agent" and is available for viewing at:
Website: https://www.mdpi.com/1999-4915/17/9/1280
PDF Version: https://www.mdpi.com/1999-4915/17/9/1280/pdf
This peer-reviewed publication provides strong support that Ruvidar® is more effective in the treatment of HSV-1 than either Acyclovir® or Metformin®, even without light-activation. Acyclovir® and its derivatives are currently known as the gold standard treatment for HSV-1.1
According to this latest research, Acyclovir® and Metformin® had little, if any, effect on the virus, once infection was established; however, Ruvidar® was able to have a dramatic inhibitory effect, post infection, without light-activation. In other words, in a normal human infection setting (onset of a cold sore lesion), using acyclovir or metformin had no beneficial effects; whereas, Ruvidar® remained highly effective in suppressing viral replication in cells that harbored active infection. Ruvidar®'s protection extended to preventing non-infected cells from contracting an HSV-1 infection, which minimized the spread of the disease to adjacent cells and if used clinically would help minimize patient duration of the disease.
In further research, Ruvidar® was shown to be effective in the treatment of Acyclovir®-resistant HSV-1 mutants. This would be highly beneficial for patients who are prone to cold sore lesions that have grown resistant to treatment with acyclovir.
This research underscores Ruvidar®'s potential as a next-generation antiviral therapy, capable of addressing both standard and drug-resistant HSV-1 infections and support its advancement into clinical development.
Kevin M. Coombs, PhD, Professor (retired), Department of Medical Microbiology, University of Manitoba stated, "Head-to-head comparisons of Ruvidar® with Acyclovir® demonstrate that Ruvidar® is much more effective in attenuating HSV- 1 in a number of ways; specifically: Ruvidar® is more effective on a molar basis than acyclovir in reducing virus yields from new infections, hence it would prove to be more cost effective overall and unlike Acyclovir®, which is ineffective against already-infected cells, Ruvidar® was highly effective against HSV-1 in cells that already harbor infection, thus allowing its use on patients, who have already presented with a cold sore lesion. The combination of Ruvidar® with Acyclovir® was more effective than either alone; hence, combinational therapies may prove advantageous. In addition, Ruvidar® remained highly effective against every Acyclovir®-resistant HSV mutant that we tested, providing hope for patients for which acyclovir has become ineffective."
Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase®, added, "Internationally, there are a limited number of antiviral medications available to treat herpes virus infections, thus limiting a patient's options, with Acyclovir® and its derivatives being the most prevalent. Theralase®'s advanced, anti-viral technology has demonstrated very high efficacy preclinically in numerous pathogenic human viruses; including, HSV-1, all at very small molar concentrations. Ruvidar® has the added benefit of being able to be effective, with or without light activation, thus allowing it to be effective in deep tissue clinical applications, where light is unable to penetrate."
Dr. Mandel continued, "The therapeutic agents currently on the market lack efficacy in treating a broad spectrum of viruses, while many of them demonstrate dose-limiting toxicities and associated side effects. We were extremely pleased by the latest preclinical data that demonstrated numerous advantages of Ruvidar® over Acyclovir®, which is considered the gold standard in treating herpes virus infections. Ruvidar® demonstrated that it was highly effective in the prophylactic protection of cells from ongoing HSV-1 infection; hence, it could be developed for preventing HSV-1 flare-ups. As an additional bonus, Ruvidar® did not develop viral resistance on its own, while proving to be highly effective against acyclovir-resistant HSV-1 mutants. The results of the preclinical data demonstrated that Acyclovir®, in combination with Ruvidar®, was more effective than when used alone in the inactivation of HSV-1. Collectively, these results have significant implications for the development of new approaches using Ruvidar® and Rutherrin® to enhance the efficacy of contemporary therapies for infectious diseases that are resistant or unresponsive to current standard treatments. We believe that the Ruvidar®-based platform technology offers significant potential to fight a broad spectrum of viruses, with the primary goal of providing a single comprehensive solution for treating HSV-1 infections."
Roger DuMoulin-White, BSc, PEng, ProDir, President and Chief Executive Officer, Theralase® stated, "The latest peer-reviewed preclinical data conducted by Dr. Coomb's lab demonstrated the superiority of Ruvidar® in the effective destruction of HSV-1 lesions versus Acyclovir® and the ability of Ruvidar® to provide efficacy in acyclovir resistant HSV-1 cells. Based on the success of this latest preclinical research, Theralase® has commenced formulation of Ruvidar® into topical form, plans to commence GLP toxicology analysis and plans to commence a Phase I/II adaptive clinical study to demonstrate the safety and efficacy of Ruvidar® in the accelerated healing of cold sore lesions in humans in 2026."
About Herpes Simplex:
Herpes Simplex Virus ("HSV"), known as herpes, is a very common infection that can cause painful blisters or ulcers on the skin of an individual. It primarily spreads by skin-to-skin contact, while it is treatable, it is not curable.2
There are two main types of HSV:2
Type 1 ("HSV-1") generally spreads by oral contact and causes infections in or around the mouth, vermilion, upper or lower lip region (oral herpes or cold sores). It can also cause genital herpes. A majority of adults are infected with HSV-1.
Type 2 ("HSV-2") spreads by sexual contact and causes herpes in the genital region of an individual.
An estimated 3.8 billion people under the age of 50 (
The global HSV treatment market size was estimated at $USD 2.8 billion in 2024 and is expected to balloon to $USD 4.7 billion by 2033.3
About Theralase® Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and drug-activated small molecule compounds 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.
About MDPI - Viruses
MDPI is a pioneer in scholarly, open access publishing, supporting academic communities, since 1996, with a mission to foster open scientific exchange in all forms, across all disciplines. MDPI has 477 peer-reviewed journals, supported by more than 295,000 academic experts. Viruses is an open access, peer-reviewed journal that provides an advanced forum for the study of viruses, with an aim to publish papers that are of significant impact to the virology community.
References:
1 Kłysik K, Pietraszek A, Karewicz A, Nowakowska M. Acyclovir in the Treatment of Herpes Viruses - A Review. Curr Med Chem. 2020;27(24):4118-4137. doi: 10.2174/0929867325666180309105519. PMID: 29521211.
2 Herpes simplex virus
3 Herpes Simplex Virus Treatment Market Size, Top Share, Key Developments | By 2033
Additional information is available at https://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; access to sufficient capital to fund the Company's operations is available on terms that are commercially favorable to the Company or at all; the Company's small molecule and formulations are effective against the diseases tested in its clinical studies; the Company's ability to comply with the terms of license agreements with third parties and as a result does not lose 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)
https://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/267607