Toronto, Ontario–(Newsfile Corp. – August 21, 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 pleased to announce that an independent screening of drugs for monkeypox (“Mpox”) highlighted cepharanthine’s potential to bind to the virus’s protein. The letter to the editor titled, “Highly accurate protein structure prediction and drug screen of monkeypox virus proteome,” is non peer reviewed and published in Journal of Infection and can be found here.
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“), is focused on the clinical development of a patented reformulated version of oral cepharanthine (“PD-001”) as a potential treatment for Medical Countermeasures and cancer.
Understanding of Mpox (monkeypox) proteins key to the function of the virus is limited. Identification of potential drugs/molecules that interact with Mpox proteins may help with treatment of Mpox virus infection. In a study by Yang et al (2023), 10 target proteins from the Mpox virus were selected due to their potential to be involved in essential functions and their potential to interact with other molecules. In the analysis aimed at screening drugs for Mpox, cepharanthine displayed significant binding affinities to all ten target proteins of Mpox. More specifically, cepharanthine showed high binding affinities to 4 of the predicted Mpox proteins (I1L, VITF3L, A42R, and E8L).1 This predicted interaction may help enhance understanding of key mechanisms of viral entry and replication for potential treatments, such as cepharanthine, of Mpox infection.
Robert Steen, CEO of PharmaDrug commented, “We are of the opinion that the last several years has shown us that the world needs more anti-viral medications in its therapeutic arsenal. We believe that PD-001, with its patented enhanced cepharanthine bioavailability, can potentially serve as a multi-indication anti-viral. We look forward to further explore cepharanthine’s therapeutic prospects for Mopx and other infectious diseases.”
As announced in a press release dated August 19, 2024, Sairiyo 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.2
The Company would like to make it clear that is not making any express or implied claims that its product (cepharanthine) has the ability to treat, eliminate or cure Monkeypox (Mpox) and/or other infectious diseases at this time.
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 effects3,4. 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.
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.