Ruvidar(TM) demonstrates higher efficacy in the treatment of Herpes Simplex Virus, Type 1 versus FDA-approved, standard of care treatments Acyclovir and Abreva in a preclinical animal model.
Toronto, Ontario--(Newsfile Corp. - April 10, 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 RuvidarTM has been proven more effective in the treatment of Herpes Simplex Virus, Type 1 ("HSV-1") versus FDA-approved, standard of care treatments Acyclovir (5%) and Abreva (10% Docosanol) in a preclinical animal model.
In the latest Theralase® research, Balb/C mice were infected with human HSV-1 virus on Day 0.
On Day 1 post-infection, these mice were treated with either: Acyclovir (5%), Abreva (10% Docosanol) or RuvidarTM (1%).
Figure 1. Acyclovir (5%) (5 days of treatment x 5 times per day)
The results support the safety and efficacy of topically applied non-light activated Ruvidar® for accelerated healing of cutaneous HSV-1 lesions in a mouse model.
Pavel Kaspler, Ph.D., Research Scientist, Theralase®, who conducted the preclinical study stated, "I have now had the opportunity to conduct my next set of experiments, where I increased the number of daily applications of Acyclovir (5%) and Abreva (10% Docosanol) from once per day to 5 times daily for 5 and 6 days, respectively. In this set of experiments, RuvidarTM (1%) remained at once daily for 5 days. As can be clearly seen from the photographs, RuvidarTM was successfully able to completely heal the HSV-1 lesions in an animal model; whereas, neither Abreva (10% Docosanol) nor Acyclovir (5%) were able to completely heal them. A very interesting observation from this experiment is that RuvidarTM (1%) was able to completely heal the HSV-1 lesions at a fraction of the dose of the other two FDA approved drugs and completed this task with an application frequency of only once per day versus 5 times daily. My next set of experiments, in conjunction with my colleagues, and Dr. Mandel will be to optimize the formulation that will be analyzed in GLP toxicology, as well as clinically evaluated in a Phase I, II and III clinical study."
Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer, Theralase® stated, "The preclinical data is what I would have predicted based on my previous research into this versatile drug; RuvidarTM (1%) is superior in efficacy, when directly compared to two FDA-approved drugs; specifically: Acyclovir (5%) and Abreva (10% Docosanol). As one of the potential Mechanisms Of Action ("MOA"), it is well established in the literature that the glycoproteins of the HSV-1 virus (glycans—gB and gC) are negatively charged, as is the Heparan Sulphate ("HS") receptors on a cell's surface (preferred binding site of the virus on a cell). This provides a novel mechanism (based on controlled electrostatic repulsion) that addresses how viruses balance between optimized viral attachment to target cells and efficient egress of progeny virus.3,4 On the other hand, RuvidarTM is positively charged.5 This allows RuvidarTM the unique ability to be able to bind to and block the glycoproteins on HSV-1, preventing binding to host cells, as well as on the HS cell surface receptors preventing the efficient egress of progeny virus. This leads to an inability of the virus to replicate, allowing accelerated healing of cold sore lesions. The Theralase® research team is currently investigating additional MOAs to explain the ability of RuvidarTM to effectively inactivate HSV-1 and to stop the progression of cold sore lesions in their tracks."
Roger DuMoulin-White, B.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer, Theralase® stated, "I am delighted with the research team's latest set of experiments demonstrating the superiority of RuvidarTM in the effective destruction of HSV-1 lesions versus Acyclovir (5%) and Abreva (10% Docosanol). Based on the success of this latest preclinical research, Theralase® will commence formulation of RuvidarTM into topical form, complete GLP toxicology and commence a Phase I/II adaptive clinical study to demonstrate the safety and efficacy of RuvidarTM in the accelerated healing of cold sore lesions in humans."
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.1
There are two main types of HSV:1
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.1
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 2033.2
References: 1Herpes simplex virus 2Herpes Simplex Virus Treatment Market Size, Top Share, Key Developments | By 2033 3 Transforms of Cell Surface Glycoproteins Charge Influences Tumor Cell Metastasis via Atypically Inhibiting Epithelial-Mesenchymal Transition Including Matrix Metalloproteinases and Cell Junctions. Mingzhe Wang et al. Bioconjugate Chemistry. Vol. 34. Issue 8. July 2023 4 Olofsson S, Bally M, Trybala E, Bergström T. Structure and Role of O-Linked Glycans in Viral Envelope Proteins. Annu Rev Virol. 2023 Sep 29;10(1):283-304. doi: 10.1146/annurev-virology-111821-121007. Epub 2023 Jul 6. PMID: 37285578. 5Ruvidar(TM) Enhances Efficacy of Cancer Drug
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.
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