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 (64%) globally have HSV-1, the main cause of oral herpes. An estimated 520 million people aged 15 to 49 (13%) globally have HSV-2, the main cause of genital herpes.2
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 Klysik 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
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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
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SOURCE: Theralase Technologies Inc.
