Ruvidar Effective in the Treatment of Herpes

Rhea-AI Summary

Theralase Technologies (TSXV: TLT) (OTCQB: TLTFF) has announced promising results for their drug Ruvidar™ in treating Herpes Simplex Virus Type 1 (HSV-1). In preclinical animal trials, Ruvidar demonstrated superior efficacy compared to standard treatments Acyclovir and Abreva.

The global HSV treatment market, valued at $2.8 billion in 2024, is projected to reach $4.7 billion by 2033, with North America holding a 37.1% market share. An estimated 3.8 billion people globally have HSV-1, highlighting significant market potential.

The research showed Ruvidar's unique mechanism of action, utilizing positive charge to block viral glycoproteins and prevent virus replication. Following these successful preclinical results, Theralase plans to begin formulating Ruvidar into topical form and commence Phase I/II adaptive clinical studies in 2025, pending funding, to evaluate its safety and efficacy in treating cold sore lesions in humans.

Positive

• Ruvidar demonstrated superior efficacy vs standard treatments (Acyclovir and Abreva) in preclinical trials
• Unique mechanism of action showing ability to block viral replication
• Targeting large market opportunity ($2.8B in 2024, expected to reach $4.7B by 2033)
• Advancing to human clinical trials with clear development pathway

Negative

• Clinical development progress dependent on securing funding in 2025
• Still in early preclinical stage, requiring extensive testing before commercialization
• Faces competition from established treatments in a crowded market

Ruvidar(TM) demonstrates higher efficacy in the treatment of Herpes Simplex Virus, Type 1 versus the standard of care treatments Acyclovir and Abreva in a preclinical animal model.

Toronto, Ontario--(Newsfile Corp. - March 24, 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 Ruvidar^TM has demonstrated a higher efficacy in the treatment of Herpes Simplex Virus, Type 1 ("HSV-1") versus standard of care treatments Acyclovir (1%) and Abreva in a preclinical animal model.

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

The market growth can be attributed to the growing concerns over HSV infection, including, oral and genital herpes. Moreover, the infection is highly contagious, spreading via saliva, vaginal secretion or semen and is acquired unknowingly. These factors highlight the increasing need for treatment throughout the projected period.³

North America accounted for the largest market share of 37.1% in 2024, which can be attributed to higher consumption of branded herpes drugs, escalating healthcare expenditure, increasing launch of generics and favorable reimbursement policies.²

The HSV-1 lifecycle begins upon contact with mucosal surfaces and it is in this niche, where the virus actively replicates inducing local lesion formation. The virus then enters local sensory nerve endings and migrates back to neuronal cell bodies in the peripheral nervous system. It is in this location where the virus enters into a latent, non-replicative stage until later reactivation.⁴

Despite longstanding attempts at therapy and prevention, HSV remains among the most prevalent human infectious viral pathogens; therefore, it's imperative to keep HSV from replicating by implementing advanced vaccines and more effective drugs to combat and defeat this pervasive disease.

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 once daily for 5 days with either: No Treatment, Abreva (a common over the counter treatment), Acyclovir (1%) or Ruvidar^TM (1%).

No Treatment

Figure 1. No treatment of HSV-1 infected cutaneous lesions

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Abreva Treatment

Figure 2. Abreva treatment of HSV-1 infected cutaneous lesions

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Acyclovir (1%) Treatment

Figure 3. Acyclovir (1%) treatment of HSV-1 infected cutaneous lesions

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Ruvidar^TM (1%) Treatment

Figure 4. Ruvidar^TM (1%) treatment of HSV-1 infected cutaneous lesions

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https://images.newsfilecorp.com/files/2786/245623_4.jpg

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 am extremely impressed with the efficacy of the Ruvidar^TM to successfully heal the HSV-1 lesions in an animal model versus common standard of care treatments, currently available, such as Abreva and Acyclovir. My next set of experiments will be to increase the number of daily applications of Abreva, Acyclovir and Ruvidar^TM (from once daily to 5 times daily) and increase the dosage of Acyclovir and Ruvidar^TM (1 to 5%) to see how this affects the healing time of HSV-1 lesions. It is my hope that my preclinical research leads to the development of a clinical treatment to aid the multitude of individuals suffering from cold sores."

Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer, Theralase® stated, "Based on the chemical properties of Ruvidar^TM, I am not surprised that it has had such a dramatic effect on the inactivation of HSV-1 lesions in this animal model. It is well established in the literature that the HSV-1 virus' glycoproteins (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.^5,6 On the other hand, Ruvidar^TM is positively charged.⁷ This allows Ruvidar^TM 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."

Roger DuMoulin-White, B.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer, Theralase® stated, "As always, I am in awe of the ability of Ruvidar^TM to effectively destroy cancer cells, as well as efficiently inactivate bacteria and viruses. Based on the success of this latest preclinical research, Theralase®, pending funding in 2025, will commence formulation of Ruvidar^TM into topical form, complete GLP toxicology and commence a Phase I/II adaptive clinical study to demonstrate the safety and efficacy of Ruvidar^TM in the accelerated healing of cold sore lesions in humans."

References:
¹ Herpes simplex virus
² Herpes Simplex Virus Treatment Market Size, Top Share, Key Developments | By 2033
³ Herpes Simplex Virus Treatment Market Size, Share & Trends Analysis Report By Type (HSV-1, HSV-2), By Drug (Acyclovir, Valacyclovir, Famciclovir), By Vaccine (Simplirix, Others), By Route of Administration, By End-use, By Region, And Segment Forecasts, 2024 - 2030
⁴ Roizman B, Knipe DM, Whitley R. Herpes Simplex Viruses. 6th ed. In: Knipe DM, Howley PM, editors. Fields Virology. 6th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2013. pp. 1823-1897.
⁵ 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
⁶ 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.
⁷ Ruvidar(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.

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/245623

FAQ

What are the key findings of Ruvidar's preclinical trials for HSV-1 treatment by TLTFF?

Ruvidar demonstrated higher efficacy than standard treatments Acyclovir and Abreva in treating HSV-1 lesions in preclinical mouse models, showing superior healing of cutaneous lesions.

What is the market potential for Theralase's (TLTFF) HSV treatment?

The global HSV treatment market is valued at $2.8B (2024) and expected to reach $4.7B by 2033, with North America holding 37.1% market share.

How does Ruvidar's mechanism of action work against HSV-1?

Ruvidar uses positive charge to bind and block viral glycoproteins and Heparan Sulphate receptors, preventing virus binding to host cells and blocking viral replication.

What are Theralase's (TLTFF) next steps for Ruvidar development in 2025?

Pending funding, Theralase plans to formulate Ruvidar into topical form, complete GLP toxicology, and begin Phase I/II adaptive clinical studies for cold sore treatment.

What is the current global prevalence of HSV-1 that TLTFF's Ruvidar aims to treat?

An estimated 3.8 billion people under age 50 (64% of global population) have HSV-1, the main cause of oral herpes.