Toronto, Ontario–(Newsfile Corp. – October 31, 2024) – PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF) (“PharmaDrug” or the “Company”), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics and previously approved drugs, is announcing it has successfully completed its stability study of its patented enteric-coated cepharanthine formulation (“PD-001″), which supports the manufacturing of clinical trial material of PD-001 for use in the Company’s first-in-human Phase 1 clinical study (the “Study”) as a potential treatment for viral infectious diseases. As announced on August 19, 2024, Sairiyo Therapeutics Inc. (“Sairiyo”), a company that is fifty-one percent (51%) owned by PharmaDrug and fourty-nine percent (49%) owned by PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF) (“PharmaTher”), received approval by the Australian Human Research Ethics Committee to initiate a first-in-human Phase 1 clinical study (the “Study”) to support PD-001 as a potential treatment for viral infectious diseases.
The six-month accelerated condition stability study (40 degrees Celsius and 75% relative humidity) was completed by Genvion Corporation, the Company’s contract development and manufacturing organization. The study demonstrated that PD-001 showed acceptable change for all measured parameters indicating that the product is stable as active in bottle or encapsulated active in bottle. Genvion Corporation will be manufacturing PD-001 clinical trial material for the Study.
Robert Steen, CEO of PharmaDrug commented, “The stability study gives us the confidence that our manufacturing strategy is appropriate to move forward with scale up and GMP activities to support clinical trials. With the study now complete, we can finally look to finalize plans to begin our phase 1 study in Australia.”
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 effects1,2. 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.
PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics and previously approved drugs. PharmaDrug owns 51% of Sairiyo Therapeutics (“Sairiyo”), a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through clinical trials and the associated regulatory approval process in the US and Europe. Sairiyo is currently developing its patented reformulation of cepharanthine, a drug that has shown substantial third party validated potential for the treatment of infectious disease and rare cancers. Sairiyo is also conducting R&D in the psychedelics space for the treatment of non-neuropsychiatric conditions. PharmaDrug also owns 100% of SecureDose Synthetics Inc. (“SecureDose”), a pharmaceutical research and development company focused on the development of synthetic formulations of currently existing drugs for potential commercialization and distribution.
For further information, please contact: