PharmaTher’s Sairiyo Therapeutics Submits Clinical Trial Application for Phase 1 Study of Patented Reformulated Cepharanthine

TORONTO, May 15, 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 (49%) owned by PharmaTher and fifty-one percent (51%) owned by PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF) ("PharmaDrug"), has submitted to the Australian Human Research Ethics Committee for review and potential approval to initiate a Phase 1 clinical study (the “Study”) of Sairiyo’s patented reformulated enteric coated version of orally bioavailable cepharanthine (“PD-001”) as a potential treatment for infectious diseases and oncology.

The Phase 1 study entitled “Phase 1 Open-label, Single Dose, 3-Way Cross-Over Trial to Assess in Healthy Volunteers the Bioavailability and Pharmacokinetics Of 30 mg and 60 mg Oral Enteric Coated Capsules of Cepharanthine Dihydrochloride in Comparison to 6 mg Oral Cepharanthine Dihydrochloride Tablets”, if approved by the Australian regulators in June 2024, will be a first-in-human study of PD-001. Sairiyo’s wholly-owned subsidiary in Australia, Sairiyo Therapeutics Australia Pty Ltd., is the sponsor of the Study.

In pursuit of its clinical strategy for PD-001, Sairiyo aims to conduct its first-in-human clinical study of PD-001 in Australia to capitalize on drug development incentives in Australia, which could earn a 43.5 percent rebate from the Australian Federal Government’s Research and Development tax incentive program. Upon completion of the clinical study, Sairiyo intends to submit an Investigational New Drug application for PD-001 to the U.S. Food and Drug Administration (FDA) to commence Phase 2 and Phase 3 clinical trials in the United States.

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.