PharmaTher’s Sairiyo Therapeutics Receives Approval to Initiate a Phase 1 Human Clinical Trial of PD-001 (Reformulated Cepharanthine)

Rhea-AI Summary

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.

Positive

• 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

Negative

• 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 (49%) owned by PharmaTher and fifty-one percent (51%) owned by PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF) ("PharmaDrug"), has received approval by the Australian Human Research Ethics Committee to initiate a first-in-human Phase 1 clinical study (the “Study”) investigating a patented reformulated enteric coated version of oral cepharanthine (“PD-001”) as a potential treatment for Medical Countermeasures and cancer. PD-001 was previously awarded a $3.4 million contract from the Defense Threat Reduction Agency (DTRA) for the Ebola virus.

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. (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.

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FAQ

What is the purpose of PharmaTher's Phase 1 clinical trial for PD-001 (PHRRF)?

The Phase 1 clinical trial aims to assess the bioavailability and pharmacokinetics of PD-001, a reformulated enteric coated version of oral cepharanthine, in healthy volunteers. This study is a important step towards developing PD-001 as a potential treatment for Medical Countermeasures and cancer.

What is the significance of the $3.4 million contract awarded to PharmaTher (PHRRF) by the Defense Threat Reduction Agency?

The $3.4 million contract from the Defense Threat Reduction Agency (DTRA) was awarded for research on PD-001's potential in treating the Ebola virus. This contract highlights the potential of PD-001 in addressing serious infectious diseases and supports its development as a Medical Countermeasure.

What are the next steps for PharmaTher (PHRRF) after completing the Phase 1 trial for PD-001?

After completing the Phase 1 trial, PharmaTher plans to submit an Investigational New Drug application to the U.S. Food and Drug Administration. This submission will allow the company to commence Phase 2 and Phase 3 clinical trials for PD-001 in the United States, furthering its development as a potential treatment.