PharmaTher’s Sairiyo Therapeutics Receives Approval to Initiate a Phase 1 Human Clinical Trial of PD-001 (Reformulated Cepharanthine)
PharmaTher Holdings (OTCQB: PHRRF) announced that Sairiyo Therapeutics, its 49% owned subsidiary, has received approval to initiate a Phase 1 clinical trial for PD-001, a reformulated enteric coated version of oral cepharanthine. The study aims to assess the bioavailability and pharmacokinetics of PD-001 in healthy volunteers. This milestone follows years of research and development and a $3.4 million contract from the Defense Threat Reduction Agency for Ebola virus research.
The trial's completion will support Sairiyo's submission of an Investigational New Drug application to the FDA for Phase 2 and 3 clinical trials in the United States. PD-001 is being developed as a potential treatment for Medical Countermeasures and cancer, with applications in infectious diseases, terrorist attacks, and pandemics.
PharmaTher Holdings (OTCQB: PHRRF) ha annunciato che Sairiyo Therapeutics, sua sussidiaria controllata al 49%, ha ricevuto l'approvazione per avviare uno studio clinico di Fase 1 per PD-001, una versione riformulata e rivestita entericamente della cepharanthine orale. Lo studio punta a valutare la biodisponibilità e la farmacocinetica di PD-001 in volontari sani. Questo traguardo segue anni di ricerca e sviluppo e un contratto di 3,4 milioni di dollari dall'Agenzia per la Riduzione delle Minacce della Difesa per la ricerca sul virus Ebola.
Il completamento dello studio sosterrà la presentazione da parte di Sairiyo di una domanda di Nuovo Farmaco Sperimentale all'FDA per le fasi 2 e 3 degli studi clinici negli Stati Uniti. PD-001 è in fase di sviluppo come potenziale trattamento per misure contro le malattie e il cancro, con applicazioni in malattie infettive, attacchi terroristici e pandemie.
PharmaTher Holdings (OTCQB: PHRRF) anunció que Sairiyo Therapeutics, su filial de la que posee el 49%, ha recibido la aprobación para iniciar un ensayo clínico de Fase 1 para PD-001, una versión reformulada con recubrimiento entérico de la cepharanthine oral. El estudio tiene como objetivo evaluar la biodisponibilidad y farmacocinética de PD-001 en voluntarios sanos. Este hito sigue a años de investigación y desarrollo y a un contrato de 3.4 millones de dólares de la Agencia de Reducción de Amenazas de Defensa para la investigación del virus del Ébola.
La finalización del ensayo apoyará la presentación de Sairiyo de una solicitud de Nuevo Medicamento en Investigación a la FDA para ensayos clínicos de Fase 2 y 3 en los Estados Unidos. PD-001 se está desarrollando como un potencial tratamiento para contramedidas médicas y cáncer, con aplicaciones en enfermedades infecciosas, ataques terroristas y pandemias.
PharmaTher Holdings (OTCQB: PHRRF)은 49%의 지분을 보유한 자회사 Sairiyo Therapeutics가 경구용 세파란틴의 내장 코팅 버전인 PD-001의 1상 임상 시험을 시작할 수 있는 승인을 받았다고 발표했습니다. 이 연구는 건강한 자원봉사자에서 PD-001의 생체이용률과 약물동태학을 평가하는 것을 목표로 합니다. 이번 이정표는 연구개발에 수년이 걸린 뒤 에볼라 바이러스 연구를 위한 방위위협감소청의 340만 달러 계약을 따낸 결과입니다.
임상 시험 완료는 Sairiyo가 미국에서 2상 및 3상 임상 시험을 위한 신약 신청서를 FDA에 제출하는 데 도움이 될 것입니다. PD-001은 의료대응 및 암에 대한 잠재적인 치료제로 개발되고 있으며, 감염병, 테러 공격 및 팬데믹에 대한 응용이 가능합니다.
PharmaTher Holdings (OTCQB: PHRRF) a annoncé que Sairiyo Therapeutics, sa filiale dont elle détient 49 %, a obtenu l'approbation pour initier un essai clinique de Phase 1 pour PD-001, une version reformulée de la cépharanthine orale avec enrobage entérique. L'étude vise à évaluer la biodisponibilité et la pharmacocinétique de PD-001 chez des volontaires en bonne santé. Ce jalon fait suite à des années de recherche et de développement ainsi qu'à un contrat de 3,4 millions de dollars de l'Agence de réduction des menaces de défense pour la recherche sur le virus Ebola.
La réalisation de l'essai soutiendra la soumission par Sairiyo d'une demande de nouveau médicament d'investigation à la FDA pour des essais cliniques de Phase 2 et 3 aux États-Unis. PD-001 est développé comme un traitement potentiel pour les contre-mesures médicales et le cancer, avec des applications dans les maladies infectieuses, les attaques terroristes et les pandémies.
PharmaTher Holdings (OTCQB: PHRRF) gab bekannt, dass Sairiyo Therapeutics, eine 49%ige Tochtergesellschaft, die Genehmigung erhalten hat, eine klinische Phase-1-Studie für PD-001, eine reformulierte enterisch beschichtete Version von oralem Cepharanthin, zu starten. Die Studie zielt darauf ab, die Bioverfügbarkeit und Pharmakokinetik von PD-001 bei gesunden Freiwilligen zu bewerten. Dieser Meilenstein folgt auf Jahre der Forschung und Entwicklung und einen 3,4 Millionen Dollar Vertrag mit der Defense Threat Reduction Agency für die Forschung zum Ebola-Virus.
Der Abschluss der Studie wird Sairiyos Einreichung eines Antrags auf ein neuartiges Medikament bei der FDA zur Durchführung von Phase-2- und Phase-3-Studien in den Vereinigten Staaten unterstützen. PD-001 wird als potenzielle Behandlung für Medizinische Gegenmaßnahmen und Krebs entwickelt, mit Anwendungen bei Infektionskrankheiten, Terroranschlägen und Pandemien.
- Approval received to initiate Phase 1 clinical trial for PD-001
- $3.4 million contract awarded by DTRA for Ebola virus research
- Potential applications in Medical Countermeasures and cancer treatment
- None.
TORONTO, Aug. 19, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, announced today Sairiyo Therapeutics Inc. (“Sairiyo”), a company that is forty-nine percent (
Fabio Chianelli, CEO of PharmaTher, commented: “We are very pleased with Sairiyo reaching this major milestone after years of research and development with the aim of unlocking the therapeutic potential of enhanced bioavailability cepharanthine for treating cancers and various medical emergencies such as infectious diseases, terrorist attacks or pandemics.”
Once completed, the Study entitled “Phase 1 Open-label, Single Dose, 3-Way Cross-Over Trial to Assess the Bioavailability and Pharmacokinetics Of 15 mg and 30 mg Capsules Containing Oral Enteric Coated Cepharanthine Dihydrochloride in Comparison to 15 mg Oral Cepharanthine Tablets in Healthy Volunteers”, will support Sairiyo’s submission of an Investigational New Drug application for PD-001 to the U.S. Food and Drug Administration to commence Phase 2 and Phase 3 clinical trials in the United States. Sairiyo’s wholly-owned subsidiary in Australia, Sairiyo Therapeutics Australia Pty Ltd., is the sponsor of the Study.
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 effects. 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. (
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
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
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FAQ
What is the purpose of PharmaTher's Phase 1 clinical trial for PD-001 (PHRRF)?
What is the significance of the $3.4 million contract awarded to PharmaTher (PHRRF) by the Defense Threat Reduction Agency?
What are the next steps for PharmaTher (PHRRF) after completing the Phase 1 trial for PD-001?
