Ruvidar More Effective in the Treatment of Herpes than FDA-Approved Treatments

Rhea-AI Summary

Theralase Technologies (OTCQB: TLTFF) has announced breakthrough results for their drug Ruvidar in treating Herpes Simplex Virus Type 1 (HSV-1). In preclinical animal studies, Ruvidar (1%) demonstrated superior efficacy compared to FDA-approved treatments Acyclovir (5%) and Abreva (10% Docosanol).

Key findings show that Ruvidar completely healed HSV-1 lesions with just one daily application over 5 days, while competing treatments required 5 applications daily for 5-6 days and still failed to achieve complete healing. The drug's effectiveness is attributed to its positive charge, which enables it to block viral glycoproteins and prevent virus replication.

Following these successful results, Theralase will proceed with formulating Ruvidar into topical form, complete GLP toxicology studies, and initiate a Phase I/II adaptive clinical study to evaluate its safety and efficacy in human patients.

Positive

• Superior efficacy compared to existing FDA-approved treatments
• Lower dosage required (1% vs 5-10%) with less frequent application (1x vs 5x daily)
• Complete healing achieved in preclinical trials
• Novel mechanism of action with potential competitive advantage

Negative

• Still in preclinical stage, requiring extensive clinical trials
• No human efficacy data available yet
• Timeline to market approval not specified

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 Ruvidar^TM 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 Ruvidar^TM (1%).

Figure 1. Acyclovir (5%) (5 days of treatment x 5 times per day)

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/247993_d66f50f894f73a8a_001full.jpg

Figure 2. Abreva (10% Docosanol) (6 days of treatment x 5 times per day)

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/247993_d66f50f894f73a8a_002full.jpg

Figure 3. Ruvidar^TM (1%) (5 days of treatment x once per day)

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/247993_d66f50f894f73a8a_004full.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 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, Ruvidar^TM (1%) remained at once daily for 5 days. As can be clearly seen from the photographs, Ruvidar^TM 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 Ruvidar^TM (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; Ruvidar^TM (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, Ruvidar^TM is positively charged.⁵ 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. The Theralase® research team is currently investigating additional MOAs to explain the ability of Ruvidar^TM 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 Ruvidar^TM 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 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."

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:
¹ Herpes simplex virus
² Herpes 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.
⁵ 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/247993

FAQ

How does Ruvidar's dosing compare to existing HSV-1 treatments?

Ruvidar (1%) requires only one application daily for 5 days, while Acyclovir (5%) and Abreva (10%) need 5 applications daily for 5-6 days.

What is the mechanism of action for TLTFF's Ruvidar in treating herpes?

Ruvidar's positive charge allows it to bind to and block viral glycoproteins and Heparan Sulphate receptors, preventing virus replication and accelerating lesion healing.

What are the next development steps for Ruvidar (TLTFF)?

Theralase will develop a topical formulation, complete GLP toxicology studies, and begin Phase I/II adaptive clinical trials.

How effective was Ruvidar compared to FDA-approved treatments in preclinical trials?

Ruvidar completely healed HSV-1 lesions in animal models, while FDA-approved Acyclovir and Abreva failed to achieve complete healing.