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PharmaTher’s Sairiyo Therapeutics Announces Independent Screening Identifying Cepharanthine’s Potential to Bind to Monkeypox (Mpox) Proteins

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PharmaTher Holdings (OTCQB: PHRRF) (CSE: PHRM) announced that Sairiyo Therapeutics Inc., a company it partially owns, reported independent screening results highlighting cepharanthine's potential to bind to monkeypox (Mpox) proteins. The study, published in the Journal of Infection, showed cepharanthine's significant binding affinities to all ten target proteins of Mpox, with high affinities to four specific proteins (I1L, VITF3L, A42R, and E8L).

This discovery may enhance understanding of viral entry and replication mechanisms for potential Mpox treatments. Additionally, Sairiyo received approval to initiate a first-in-human Phase 1 clinical study with PD-001, targeting Medical Countermeasures. PD-001 previously received a $3.4 million contract from the Defense Threat Reduction Agency for Ebola virus research.

PharmaTher Holdings (OTCQB: PHRRF) (CSE: PHRM) ha annunciato che Sairiyo Therapeutics Inc., una società di cui possiede una partecipazione, ha riportato risultati di screening indipendenti che evidenziano il potenziale della cefarampina di legarsi alle proteine del monkeypox (Mpox). Lo studio, pubblicato nel Journal of Infection, ha mostrato le significative affinità di legame della cefarampina con tutte le dieci proteine target del Mpox, con affinità elevate per quattro proteine specifiche (I1L, VITF3L, A42R ed E8L).

Questa scoperta potrebbe migliorare la comprensione dei meccanismi di ingresso e replicazione virale per potenziali trattamenti contro il Mpox. Inoltre, Sairiyo ha ricevuto l'approvazione per avviare uno studio clinico di Fase 1 su esseri umani con PD-001, mirato a Contromisure Mediche. PD-001 ha precedentemente ricevuto un contratto di 3,4 milioni di dollari dalla Defense Threat Reduction Agency per la ricerca sul virus Ebola.

PharmaTher Holdings (OTCQB: PHRRF) (CSE: PHRM) anunció que Sairiyo Therapeutics Inc., una empresa de la que posee parcialmente acciones, informó resultados de cribado independientes que destacan el potencial de la cefarampina para unirse a las proteínas del monkeypox (Mpox). El estudio, publicado en el Journal of Infection, mostró la significativa afinidad de unión de la cefarampina a las diez proteínas objetivo del Mpox, con altas afinidades a cuatro proteínas específicas (I1L, VITF3L, A42R y E8L).

Este descubrimiento puede mejorar la comprensión de los mecanismos de entrada y replicación viral para posibles tratamientos del Mpox. Además, Sairiyo recibió la aprobación para iniciar un estudio clínico de Fase 1 en humanos con PD-001, orientado a Contramedidas Médicas. PD-001 había recibido previamente un contrato de 3,4 millones de dólares de la Defense Threat Reduction Agency para la investigación del virus Ebola.

PharmaTher Holdings (OTCQB: PHRRF) (CSE: PHRM)는 부분적으로 소유하고 있는 Sairiyo Therapeutics Inc.가 원숭이두창(Mpox) 단백질에 결합할 수 있는 세파란틴의 잠재성을 강조하는 독립적 스크리닝 결과를 보고했다고 발표했다. 감염학 저널(Journal of Infection)에 발표된 이 연구는 세파란틴의 Mpox 열 목표 단백질 10개에 대한 상당한 결합 친화도를 보여주며, 특히 네 개의 특정 단백질(I1L, VITF3L, A42R 및 E8L)에 높은 친화도를 보였다.

이 발견은 Mpox 치료를 위한 바이러스 진입 및 복제 메커니즘에 대한 이해를 향상시킬 수 있다. 또한, Sairiyo는 의료 대응책을 목표로 하는 인간을 대상으로 한 1상 임상 시험을 PD-001로 시작하도록 승인받았다. PD-001은 이전에 에볼라 바이러스 연구를 위해 Defense Threat Reduction Agency로부터 340만 달러의 계약을 받았다.

PharmaTher Holdings (OTCQB: PHRRF) (CSE: PHRM) a annoncé que Sairiyo Therapeutics Inc., une entreprise dont elle détient une participation partielle, a rapporté des résultats de dépistage indépendants soulignant le potentiel du cépharanthine à se lier aux protéines du monkeypox (Mpox). L'étude, publiée dans le Journal of Infection, a montré les affinités de liaison significatives du cépharanthine à l'ensemble des dix protéines cibles du Mpox, avec des affinités élevées pour quatre protéines spécifiques (I1L, VITF3L, A42R et E8L).

Cette découverte pourrait améliorer la compréhension des mécanismes d'entrée et de réplication virale pour de potentiels traitements du Mpox. De plus, Sairiyo a reçu l'approbation pour initier une étude clinique de Phase 1 sur l'homme avec PD-001, ciblant les Contre-mesures Médicales. PD-001 avait précédemment reçu un contrat de 3,4 millions de dollars de la Defense Threat Reduction Agency pour des recherches sur le virus Ebola.

PharmaTher Holdings (OTCQB: PHRRF) (CSE: PHRM) gab bekannt, dass Sairiyo Therapeutics Inc., an dem es teilweise beteiligt ist, unabhängige Screening-Ergebnisse präsentiert hat, die das Potenzial von Cepharanthin zur Bindung an die Monkeypox (Mpox) Proteine hervorheben. Die Studie, veröffentlicht im Journal of Infection, zeigte die signifikanten Bindungsaffinitäten von Cepharanthin an allen zehn Zielproteinen von Mpox, mit hohen Affinitäten zu vier spezifischen Proteinen (I1L, VITF3L, A42R und E8L).

Diese Entdeckung könnte das Verständnis der Virusaufnahme und Replikationsmechanismen für potenzielle Behandlungen von Mpox verbessern. Darüber hinaus erhielt Sairiyo die Genehmigung, eine erste klinische Phase-1-Studie mit PD-001 zu beginnen, die auf medizinische Gegenmaßnahmen abzielt. PD-001 erhielt zuvor einen Vertrag über 3,4 Millionen Dollar von der Defense Threat Reduction Agency für die Forschung zum Ebola-Virus.

Positive
  • Independent screening identified cepharanthine's potential to bind to monkeypox proteins
  • Cepharanthine showed high binding affinities to 4 specific Mpox proteins
  • Approval received for first-in-human Phase 1 clinical study with PD-001
  • PD-001 previously awarded $3.4 million contract for Ebola virus research
Negative
  • None.

TORONTO, Aug. 21, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, announces that Sairiyo Therapeutics Inc. (“Sairiyo”), a company that is forty-nine percent (49%) owned by PharmaTher and fifty-one percent (51%) owned by PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF), announced today that an independent screening of drugs for monkeypox (“Mpox”) highlighted cepharanthine’s potential to bind to the virus’s proteins. The letter to the editor titled, "Highly accurate protein structure prediction and drug screen of monkeypox virus proteome", is non peer reviewed and published in Journal of Infection and can be found here.

Understanding of Mpox (monkeypox) proteins key to the function of the virus is limited. Identification of potential drugs/molecules that interact with Mpox proteins may help with treatment of Mpox virus infection. In a study by Yang et al (2023), 10 target proteins from the Mpox virus were selected due to their potential to be involved in essential functions and their potential to interact with other molecules. In the published research study aimed at screening drugs for Mpox, cepharanthine displayed significant binding affinities to all ten target proteins of Mpox. More specifically, cepharanthine showed high binding affinities to 4 of the predicted Mpox proteins (I1L, VITF3L, A42R, and E8L).1 This predicted interaction may help enhance understanding of key mechanisms of viral entry and replication for potential treatments of Mpox infection, cepharanthine.

As announced on August 19, 2024, Sairiyo received approval by the Australian Human Research Ethics Committee to initiate a first-in-human Phase 1 clinical study (the “Study”) with PD-001. Sairiyo is targeting PD-001 as a potential treatment for Medical Countermeasures. PD-001 was previously awarded a $3.4 million contract from the Defense Threat Reduction Agency (DTRA) for the Ebola virus. 2

The Company would like to make it clear that is not making any express or implied claims that its product (cepharanthine) has the ability to treat, eliminate or cure Monkeypox (Mpox) and/or other infectious diseases at this time.

About PD-001 (Enteric-coated Oral Cepharanthine)

Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to successfully treat a variety of acute and chronic diseases. In clinical research, cepharanthine has been shown to exhibit multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic effects3,4. However, historically cepharanthine's low oral bioavailability has represented a major obstacle to realizing its full clinical potential.

Compared to generic cepharanthine, PD-001 has been shown in rodent and non-rodent models to possess markedly improved oral bioavailability (more easily absorbed). These findings support the development of an orally administered formulation, and in so doing, removes the undesirable requirement for frequent intravenous dosing to maintain therapeutic levels of drug in circulation. Sairiyo endeavours to develop an efficacious oral therapeutic to potentially improve outcomes for infectious disease and oncology applications.

PD-001 is protected by US Patent US10576077, with a patent expiration date of March 23, 2036.

About Sairiyo Therapeutics Inc.

Sairiyo Therapeutics Inc., which is owned by PharmDrug Inc. (51%) and PharmaTher (49%), is focused on advancing the clinical development of an improved and patented enteric-coated orally bioavailable formulation of cepharanthine (PD-001) as a potential treatment for Medical Countermeasures and oncology.

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of KETARX™ (Ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, mental health, and neurological indications. PharmaTher owns 49% of Sairiyo Therapeutics Inc., which focuses on advancing the clinical development of an improved and patented enteric-coated orally bioavailable formulation of cepharanthine (PD-001) for medical countermeasures and cancer. Learn more at PharmaTher.com.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results of the Company. Forward looking statements in this press release relate to the potential for cepharanthine as a treatment for Mpox and the development of the Company's business. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements.

Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; the actual results of the Company's future operations; competition; changes in legislation affecting the Company; the ability to obtain and maintain required permits and approvals, the timing and availability of external financing on acceptable terms; lack of qualified, skilled labour or loss of key individuals.

A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company’s disclosure documents on the SEDAR+ website at www.sedarplus.ca. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

The Company's securities have not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or "U.S. Persons", as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful.

Forward-looking information contained in this press release is expressly qualified by this cautionary statement. The forward-looking information contained in this press release represents the expectations of the Company as of the date of this press release and, accordingly, are subject to change after such date. However, the Company expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

References:

  1. Yang Q, Xia D, Syed AAS, Wang Z, Shi Y. Highly accurate protein structure prediction and drug screen of monkeypox virus proteome. J Infect. 2023 Jan;86(1):66-117. doi: 10.1016/j.jinf.2022.08.006. Epub 2022 Aug 11. PMID: 35964685; PMCID: PMC9367171.
  2. https://www.swri.org/press-release/southwest-research-institute-texas-biomedical-research-institute-awarded-34-million
  3. Saito T, Hikita M, Kohno K, Tanimura H, Miyahara M, Kobayashi M. Enhanced expression of the multidrug resistance gene in vindesine-resistant human esophageal cancer cells. Oncology. 1994 Sep-Oct;51(5):440-5. doi: 10.1159/000227380. PMID: 8052486.
  4. Zhou P, Zhang R, Wang Y, Xu D, Zhang L, Qin J, Su G, Feng Y, Chen H, You S, Rui W, Liu H, Chen S, Chen H, Wang Y. Cepharanthine hydrochloride reverses the mdr1 (P-glycoprotein)-mediated esophageal squamous cell carcinoma cell cisplatin resistance through JNK and p53 signals. Oncotarget. 2017 Nov 27;8(67):111144-111160. doi: 10.18632/oncotarget.22676. Erratum in: Oncotarget. 2021 Jan 05;12(1):61-62. PMID: 29340044; PMCID: PMC5762312.

FAQ

What did the independent screening reveal about cepharanthine and monkeypox (Mpox) for PharmaTher (PHRRF)?

The independent screening revealed that cepharanthine, a compound of interest to PharmaTher (PHRRF), displayed significant binding affinities to all ten target proteins of monkeypox (Mpox), with high affinities to four specific proteins (I1L, VITF3L, A42R, and E8L).

What recent approval did Sairiyo Therapeutics, partially owned by PharmaTher (PHRRF), receive in August 2024?

In August 2024, Sairiyo Therapeutics received approval from the Australian Human Research Ethics Committee to initiate a first-in-human Phase 1 clinical study with PD-001, targeting Medical Countermeasures.

What previous funding did PD-001, associated with PharmaTher (PHRRF), receive for infectious disease research?

PD-001 previously received a $3.4 million contract from the Defense Threat Reduction Agency (DTRA) for research related to the Ebola virus.

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