PharmaTher’s Sairiyo Therapeutics Inc. Advances Clinical Development of Patented Reformulated Cepharanthine for Phase 1 Study in Australia

2024-02-22

临床1期

Feb. 21, 2024 -- 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 initiated its regulatory and clinical development plan to evaluate Sairiyo’s patented reformulated enteric coated version of orally bioavailable cepharanthine (“PD-001”) as a potential treatment for oncology and infectious diseases in a Phase1 clinical study in Australia. PD-001 is protected by US Patent US10576077, with a patent expiration date of March 23, 2036.

In pursuit of its clinical strategy for PD-001, Sairiyo is establishing a wholly-owned subsidiary in Australia to conduct the proposed Phase 1 study and capitalize on drug development incentives in Australia. Sairiyo could earn a 43.5 percent rebate from the Australian Federal Government’s Research and Development tax incentive program.

As announced by PharmaDrug on February 14, 2024, the technical transfer and development activities for PD-001 are completed and successfully demonstrated the ability to manufacture clinical GMP manufacturing batches of PD-001 to support future filings to Australia's Therapeutic Goods Administration (“TGA”) and the Food and Drug Administration (“FDA”) in the United States. Manufacturing of product for clinical studies is scheduled for the second quarter of 2024. Sairiyo has commenced working on a regulatory application to the TGA for its proposed Phase 1 study in Australia.

Fabio Chianelli, CEO and Chairman of PharmaTher, commented, “We are pleased that our investment in Sairiyo is being unlocked as it approaches its next phase of growth as a clinical-stage company exploring a patented reformulated orally bioavailable version of cepharanthine that has the potential to treat responsive cancers and infectious diseases. We expect to submit the regulatory package to the TGA for a proposed Phase 1 clinical study in Australia in Q2-2024.”

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) to treat responsive cancers and infectious disease, including COVID-19.

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.

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) to treat responsive cancers and infectious diseases, including COVID-19. Learn more at PharmaTher.com.

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