Latest news with #HerpesSimplexVirus
Associated Press
6 days ago
- Business
- Associated Press
Theralase(R) 1Q2025 Financial Statements
Toronto, Ontario--(Newsfile Corp. - May 30, 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 has released the Company's unaudited interim consolidated 1Q2025 financial statements ('Financial Statements'). Theralase® will be hosting a conference call on Monday June 9 th, 2025 at 11:00 am ET, which will include a presentation of the financial and operational results for the fiscal quarter ending March 31 st, 2025. Questions are welcome; however, to ensure we have time to review and properly address them during the call, please send them in advance to [email protected]. An archived version will be available on the website following the conference call. Financial Summary: For the three-month period ended March 31 st: [ This image cannot be displayed. Please visit the source: ] 1 Other represents foreign exchange, interest accretion on lease liabilities and / or interest income To view an enhanced version of this graphic, please visit: Financial Highlights For the three-month period ended March 31, 2025: Operational Highlights Private Placements The Company has raised approximately $CAN 6.3 million over the last 2 years through non-brokered private placements in support of its research and development programs. It is currently investigating the use of a full-service investment bank in the United States to advise on potential financings and US listing opportunities. Information on any future financings will be released once available in accordance with applicable securities laws. Herpes Simplex Virus ('HSV') Treatment Program Theralase® continues preclinical development of its HSV treatment using non-light activated and light-activated small molecules. The Company is actively working on in-vitro, and in the near future, in-vivo HSV preclinical models to finalize a formulation for optimal dermal penetration to increase patient safety and efficacy. Good Laboratory Practice ('GLP') toxicology studies will commence once a formulation has been finalized. Additional details will be announced as strategic objectives are achieved. Phase II Bladder Cancer Study Update ('Study II') Interim Clinical Results For the primary endpoint of Study II (Complete Response ('CR') at any point in time) 62% of patients provided the Study Procedure (Study Drug activated by the Study Device) demonstrated a CR. Including patients, who demonstrated an Indeterminate Response ('IR') (negative cystoscopy and positive or suspicious urine cytology), the Total Response ('TR') increases to 70%. This represents that approximately 2 out of 3 BCG-Unresponsive NMIBC CIS patients treated with Theralase®'s unique Study Procedure are demonstrating complete destruction of their bladder cancer. For the secondary endpoint of Study II (duration of CR) 42% of treated patients who achieved a CR, maintained their CR response for at least 12 months (450 days from date of Study Procedure). For the tertiary endpoint of Study II (safety of Study Procedure) 100% (69/69) experienced no Serious Adverse Events ('SAEs') directly related to the Study Drug or Study Device. Outside of the defined endpoints of Study II, Theralase® has demonstrated a duration of CR at extended time points of 23% at 2 years, 21% at 3 years and 2% at 7 years. Note: Not all patients have been assessed at these extended time points. As more clinical data is collected, the duration of CR at 2, 3 and 7 years may increase. Theralase® is on track to complete enrollment in Study II by the summer of 2025. This will allow the Company to report on 75 patients who have completed Study II in December 2025 and to report on all 90 patients by September 2026. Upon follow-up of all patients, the Company plans to submit a New Drug Application ('NDA') to Health Canada and the FDA in 4Q2026, with a decision expected by the respective regulatory authorities on a marketing approval in 2027. As Theralase® completes enrollment in Study II, it is actively searching for commercialization partners for international marketing and sales of Ruvidar®. To this end, Theralase® is in various stages of initial and advanced discussions with international pharmaceutical companies for various geographical territories concerning: In recent discussions with the FDA, the Company has decided that since Study II is 91% complete, the best course of action is not to pursue Break Through Designation, but to complete Study II and submit the clinical data to the FDA in a formal NDA. At the end of the meeting, the FDA made a comment that they were impressed that the interim clinical data obtained to date was able to be achieved with only one clinical treatment, in the majority of cases. Ruvidar® has demonstrated 10 years of shelf life, strongly supporting the stability of the molecule and the ability of clinics to store the small molecule for extended periods of time. Additional Oncology Targets Theralase® has combined Ruvidar® with transferrin (human glycoprotein) to form Rutherrin®. Rutherrin® is a strong candidate for the systemic treatment of recurrent, deep seated and/or progressive cancers. Due to the limitations of using laser light to activate Rutherrin® in deep oncological targets, Theralase® plans to activate Rutherrin® with radiation therapy to increase the 'tumour's damage zone' and the effectiveness of Theralase®'s small molecule beyond the reach of light in the body. Rutherrin®, if clinically proven, will be able to 'hunt' and 'localize' into cancer cells and when activated by radiation 'destroy' them; wherever, they may reside in the body. The Company expects to complete Good Laboratory Practice toxicology analysis in 4Q2025 to allow commencement of a Phase 0/I/II adaptive clinical study in 1Q2026 for the following indications: 1) Glio Blastoma Multiforme ('GBM') Brain Cancer Treatment 2) Non-Small Cell Lung Cancer ('NSCLC') Treatment 3) Pancreatic Cancer 4) Colorectal Cancer 5) Muscle Invasive Bladder Cancer ('MIBC') Treatment 6) Herpes Simplex Virus ('HSV-1") Topical Treatment for Cold Sore Lesions For additional information, please refer to the Company's Management's Discussion and Analysis ('MD&A') available at About Ruvidar®: Ruvidar®(TLD-1433) is a small molecule, able to be activated by light, radiation, sound and/or other drugs, intended for the safe and effective destruction of various cancers, bacteria and viruses. 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 and 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 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 outInvestor Inquiries - Theralase Technologies. For More Information: (843-5273) (5273) Kristina Hachey, CPA Chief Financial Officer X 224 [email protected] To view the source version of this press release, please visit
Associated Press
24-03-2025
- Health
- Associated Press
Ruvidar Effective in the Treatment of Herpes
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. TM (1%). Figure 2. Abreva treatment of HSV-1 infected cutaneous lesions To view an enhanced version of this graphic, please visit: Acyclovir (1%) Treatment [ This image cannot be displayed. Please visit the source: ] Figure 3. Acyclovir (1%) treatment of HSV-1 infected cutaneous lesions Cannot view this image? Visit: Ruvidar TM (1%) Treatment [ This image cannot be displayed. Please visit the source: ] Figure 4. Ruvidar TM (1%) treatment of HSV-1 infected cutaneous lesions Cannot view this image? Visit: 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., 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, 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. ' 1 2 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 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 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 and 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. (5273)
Yahoo
24-03-2025
- Health
- Yahoo
Ruvidar Effective in the Treatment of Herpes
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 RuvidarTM 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 RuvidarTM (1%). No Treatment Figure 1. No treatment of HSV-1 infected cutaneous lesionsTo view an enhanced version of this graphic, please visit: Abreva Treatment Figure 2. Abreva treatment of HSV-1 infected cutaneous lesionsTo view an enhanced version of this graphic, please visit: Acyclovir (1%) Treatment Figure 3. Acyclovir (1%) treatment of HSV-1 infected cutaneous lesionsCannot view this image? Visit: RuvidarTM (1%) Treatment Figure 4. RuvidarTM (1%) treatment of HSV-1 infected cutaneous lesionsCannot view this image? Visit: 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 RuvidarTM 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 RuvidarTM (from once daily to 5 times daily) and increase the dosage of Acyclovir and RuvidarTM (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., Chief Scientific Officer, Theralase® stated, "Based on the chemical properties of RuvidarTM, 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, RuvidarTM is positively charged.7 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." Roger DuMoulin-White, President and Chief Executive Officer, Theralase® stated, "As always, I am in awe of the ability of RuvidarTM 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 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." References:1 Herpes simplex virus2 Herpes Simplex Virus Treatment Market Size, Top Share, Key Developments | By 20333 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 - 20304 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 20236 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 and 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: (843-5273) (5273) Kristina Hachey, CPAChief Financial Officer X 224khachey@ To view the source version of this press release, please visit Sign in to access your portfolio
Yahoo
13-02-2025
- Health
- Yahoo
CORRECTING AND REPLACING: Theralase(R) Demonstrates Effective Treatment of Herpes
This Press Release updates numerical list in reference section Theralase® validates previous University of Manitoba research by demonstrating that RuvidarTM is safe and effective in the treatment of the Herpes Simplex Virus in an animal model. TORONTO, ON / / February 13, 2025 / Theralase® Technologies Inc. ("Theralase®" or the "Company") (TSXV:TLT)(OTCQB:TLTFF), 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 the previous University of Manitoba research has now been validated, proving that RuvidarTM is safe and effective in the inactivation of Herpes Simplex Virus, Type 1 ("HSV-1") in an animal model. Herpes Simplex Virus ("HSV"), known as herpes, is a common infection that can cause painful blisters or ulcers. It primarily spreads by skin-to-skin contact. It is treatable but not curable.1 There are two types of HSV: 1 Type 1 ("HSV-1") mostly spreads by oral contact and causes infections in or around the mouth (oral herpes or cold sores). It can also cause genital herpes. Most adults are infected with HSV-1. Type 2 ("HSV-2") spreads by sexual contact and causes genital herpes. An estimated 3.8 billion people under age 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 2.5 billion in 2023 and is expected to grow at a Compound Annual Growth Rate ("CAGR") of 8.1% from 2024 to 2030. 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.2 North America accounted for the largest market share of 32.4% in 2023, 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.3 The ability of HSV-1 to infect and establish latency in neurons allows for lifelong infection and can provide the virus with access to other sites such as the central nervous system. Recent research has implicated HSV-1 infection with the development of disease later in life, including Parkinson's and Alzheimer's diseases.4,5 Similarly, reactivation of HSV-1 in autonomic nerves that innervate coronary arteries may introduce lytic virus to vascular endothelial cells, causing local injury, thrombosis and arteriosclerosis, as well as potentially contributing to various other cardiovascular disorders.6,7 Evidence has also accumulated indicating that, in addition, HSV may be a cause of human cancers.8 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 scourge to the human race. In the latest Theralase® research, Balb/C mice were infected with human HSV-1 virus. On day 6 post-infection, 20 uL of 1% Ruvidar® solution was applied topically over the area of well-developed lesions, once daily for 4 days. Four days of Ruvidar® treatment resulted in complete healing of the HSV-1 cutaneous lesions. Figure 1. Four days of Ruvidar® treatment in Balb/C mice with HSV-1 infected cutaneous lesions The results support the safety and efficacy of topically applied non-light activated Ruvidar® against cutaneous HSV-1 lesions in a mouse model. Kevin Coombs, B.A., M.A., Ph.D., professor of medical microbiology and infectious diseases at the Max Rady College of Medicine, University of Manitoba (retired) stated, "I am delighted that Theralase® researchers were able to successfully translate my team's cellular inactivation of HSV into a safe and effective therapy in an animal model. Their research may prove to be instrumental in the development of a clinical program that will have real world impacts on the lives of billions of people infected with this prolific disease." Arkady Mandel, M.D., Ph.D., Chief Scientific Officer, Theralase® stated, "I am excited by the ground-breaking results of our first animal experiments in which we successfully treated laboratory mice with HSV-1. Herpes is an extremely difficult disease to treat, as it prefers to reside inactive in nerve cells and then reawaken due to various stimuli (i.e., illness, fever, sun exposure, menstrual period, injury, emotional stress or surgery) to induce painful and unsightly skin lesions. It has also been linked with the development of chronic disease, such as cardiovascular disorders and cancer. Many people living with HSV are concerned about the risk of transmitting the disease to other people. Our goal, as we advance into clinical development, is to safely and effectively treat people with HSV infections, so that they are less self-conscious of outbreaks and the risk of transmitting the virus to another person. I hope this research lays the groundwork for Theralase® to provide therapy to safely and effectively treat herpes." Roger DuMoulin-White, President and Chief Executive Officer, Theralase® stated, "Based on the success of Theralase®'s latest research, Theralase® plans to develop a vaccine and therapeutic for the prevention and treatment of HSV, with clinical development to commence thereafter." References: Herpes simplex virus 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 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. Mangold CA, Szpara ML. Persistent infection with herpes simplex virus 1 and Alzheimer's disease-a call to study how variability in both virus and host may impact disease. Viruses. 2019;11: 966. pmid:31635156. Benditt EP, Barrett T, McDougall JK. Viruses in the etiology of atherosclerosis. Proc Natl Acad Sci. 1983;80: 6386-6389. pmid:6312457. Phelps A, Gates AJ, Eastaugh L, Hillier M, Ulaeto DO. Comparative Efficacy of Intramuscular and Scarification Routes of Administration of Live Smallpox Vaccine in a Murine Challenge Model. Vaccine. 2017 Jul 5;35(31):3889-3896. doi: 10.1016/ Epub 2017 Jun 9. Shchelkunov SN, Sergeev AA, Pyankov SA, Titova KA, Yakubitskiy SN. Smallpox vaccination in a mouse model. Vavilovskii Zhurnal Genet Selektsii. 2023 Oct;27(6):712-718. doi: 10.18699/VJGB-23-82. 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 and 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: (843-5273) (5273) Kristina Hachey, CPAChief Financial Officer X 224khachey@ SOURCE: Theralase Technologies, Inc. View the original press release on ACCESS Newswire Sign in to access your portfolio
Yahoo
12-02-2025
- Health
- Yahoo
Theralase(R) Demonstrates Effective Treatment of Herpes
Theralase® validates previous University of Manitoba research by demonstrating that RuvidarTM is safe and effective in the treatment of the Herpes Simplex Virus in an animal model. TORONTO, ON / / February 12, 2025 / Theralase® Technologies Inc. ("Theralase®" or the "Company") (TSXV:TLT)(OTCQB:TLTFF), 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 the previous University of Manitoba research has now been validated, proving that RuvidarTM is safe and effective in the inactivation of Herpes Simplex Virus, Type 1 ("HSV-1") in an animal model. Herpes Simplex Virus ("HSV"), known as herpes, is a common infection that can cause painful blisters or ulcers. It primarily spreads by skin-to-skin contact. It is treatable but not curable.1 There are two types of HSV: 1 Type 1 ("HSV-1") mostly spreads by oral contact and causes infections in or around the mouth (oral herpes or cold sores). It can also cause genital herpes. Most adults are infected with HSV-1. Type 2 ("HSV-2") spreads by sexual contact and causes genital herpes. An estimated 3.8 billion people under age 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 2.5 billion in 2023 and is expected to grow at a Compound Annual Growth Rate ("CAGR") of 8.1% from 2024 to 2030. 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.2 North America accounted for the largest market share of 32.4% in 2023, 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.3 The ability of HSV-1 to infect and establish latency in neurons allows for lifelong infection and can provide the virus with access to other sites such as the central nervous system. Recent research has implicated HSV-1 infection with the development of disease later in life, including Parkinson's and Alzheimer's diseases.4,5 Similarly, reactivation of HSV-1 in autonomic nerves that innervate coronary arteries may introduce lytic virus to vascular endothelial cells, causing local injury, thrombosis and arteriosclerosis, as well as potentially contributing to various other cardiovascular disorders.6,7 Evidence has also accumulated indicating that, in addition, HSV may be a cause of human cancers.8 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 scourge to the human race. In the latest Theralase® research, Balb/C mice were infected with human HSV-1 virus. On day 6 post-infection, 20 uL of 1% Ruvidar® solution was applied topically over the area of well-developed lesions, once daily for 4 days. Four days of Ruvidar® treatment resulted in complete healing of the HSV-1 cutaneous lesions. Figure 1. Four days of Ruvidar® treatment in Balb/C mice with HSV-1 infected cutaneous lesions The results support the safety and efficacy of topically applied non-light activated Ruvidar® against cutaneous HSV-1 lesions in a mouse model. Kevin Coombs, B.A., M.A., Ph.D., professor of medical microbiology and infectious diseases at the Max Rady College of Medicine, University of Manitoba (retired) stated, "I am delighted that Theralase® researchers were able to successfully translate my team's cellular inactivation of HSV into a safe and effective therapy in an animal model. Their research may prove to be instrumental in the development of a clinical program that will have real world impacts on the lives of billions of people infected with this prolific disease." Arkady Mandel, M.D., Ph.D., Chief Scientific Officer, Theralase® stated, "I am excited by the ground-breaking results of our first animal experiments in which we successfully treated laboratory mice with HSV-1. Herpes is an extremely difficult disease to treat, as it prefers to reside inactive in nerve cells and then reawaken due to various stimuli (i.e., illness, fever, sun exposure, menstrual period, injury, emotional stress or surgery) to induce painful and unsightly skin lesions. It has also been linked with the development of chronic disease, such as cardiovascular disorders and cancer. Many people living with HSV are concerned about the risk of transmitting the disease to other people. Our goal, as we advance into clinical development, is to safely and effectively treat people with HSV infections, so that they are less self-conscious of outbreaks and the risk of transmitting the virus to another person. I hope this research lays the groundwork for Theralase® to provide therapy to safely and effectively treat herpes." Roger DuMoulin-White, President and Chief Executive Officer, Theralase® stated, "Based on the success of Theralase®'s latest research, Theralase® plans to develop a vaccine and therapeutic for the prevention and treatment of HSV, with clinical development to commence thereafter." References: 1Herpes simplex virus 2 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 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. Mangold CA, Szpara ML. Persistent infection with herpes simplex virus 1 and Alzheimer's disease-a call to study how variability in both virus and host may impact disease. Viruses. 2019;11: 966. pmid:31635156. Benditt EP, Barrett T, McDougall JK. Viruses in the etiology of atherosclerosis. Proc Natl Acad Sci. 1983;80: 6386-6389. pmid:6312457. Phelps A, Gates AJ, Eastaugh L, Hillier M, Ulaeto DO. Comparative Efficacy of Intramuscular and Scarification Routes of Administration of Live Smallpox Vaccine in a Murine Challenge Model. Vaccine. 2017 Jul 5;35(31):3889-3896. doi: 10.1016/ Epub 2017 Jun 9. Shchelkunov SN, Sergeev AA, Pyankov SA, Titova KA, Yakubitskiy SN. Smallpox vaccination in a mouse model. Vavilovskii Zhurnal Genet Selektsii. 2023 Oct;27(6):712-718. doi: 10.18699/VJGB-23-82. 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 and 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: (843-5273) (5273) Kristina Hachey, CPAChief Financial Officer X 224khachey@ SOURCE: Theralase Technologies, Inc. View the original press release on ACCESS Newswire Sign in to access your portfolio
