Sairiyo Therapeutics Gets Nod for Phase 1 Trial of PD-001

TORONTO, Aug. 19, 2024, PharmaTher Holdings Ltd. (PharmaTher) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, has announced that its partially owned company, Sairiyo Therapeutics Inc. (Sairiyo), has received approval from the Australian Human Research Ethics Committee to commence a first-in-human Phase 1 clinical study. This study will investigate a patented reformulated enteric-coated version of oral cepharanthine (PD-001) as a potential treatment for medical countermeasures and cancer. PD-001 previously received a $3.4 million contract from the Defense Threat Reduction Agency (DTRA) for the Ebola virus.

Fabio Chianelli, CEO of PharmaTher, expressed his satisfaction with Sairiyo achieving this significant milestone after years of research and development aimed at enhancing the therapeutic potential of cepharanthine for treating cancers and various medical emergencies such as infectious diseases, terrorist attacks, or pandemics. The study, titled "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 aid 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 Therapeutics Australia Pty Ltd., a wholly-owned subsidiary of Sairiyo in Australia, is the sponsor of the study.

Cepharanthine, a natural product and an approved drug in Japan for over 70 years, has been successfully used to treat various acute and chronic diseases. Clinical research has shown that cepharanthine exhibits multiple pharmacological properties, including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral, and anti-parasitic effects. However, the low oral bioavailability of cepharanthine has historically limited its full clinical potential. PD-001, compared to generic cepharanthine, has demonstrated significantly improved oral bioavailability in rodent and non-rodent models. This enhanced bioavailability supports the development of an oral formulation, eliminating the need for frequent intravenous dosing to maintain therapeutic levels of the drug in circulation. Sairiyo aims to develop an effective oral therapeutic to improve outcomes for infectious disease and oncology applications. PD-001 is protected under US Patent US10576077, which is set to expire on March 23, 2036.

Sairiyo Therapeutics Inc. is a joint venture between PharmaDrug Inc. (51%) and PharmaTher (49%), focusing on advancing the clinical development of an improved and patented enteric-coated orally bioavailable formulation of cepharanthine (PD-001) for medical countermeasures and oncology.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is dedicated to the development and commercialization of KETARX™ (Ketamine), addressing 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 PD-001 for medical countermeasures and cancer.