PharmaDrug Inc. (CSE: PHRX) (OTCQB: LMLLF) (“PharmaDrug” or the “Company“), is pleased to provide an update on the development activities of the Company’s patented reformulated enteric coated version of orally bioavailable Cepharanthine (PD-001) as a potential treatment for oncology and infectious disease. The technical transfer and development activities with Genvion Corporation are well-underway in preparation for clinical GMP manufacturing batches of PD-001 to support future filings to Australia’s Therapeutic Goods Administration (TGA) and Food and Drug Administration (FDA) in the United States.
“With the PharmaTher partnership now in full swing and the product safely in the hands of Genvion, we are excited by the full renewal of the PD-001 program and look forward to significantly advancing the clinical ready batch for in human trials for several potential indications in Australia and ultimately in the United Sates.”
-Robert Steen, CEO and Chairman of PharmaDrug
Current development activities include the establishment of analytical testing methods, manufacturing protocols, as well as execution and performance assessment approaches for PD-001 API to enable scale up activities for future clinical research needs. Manufacturing of a feasibility batch to demonstrate capability will occur within this quarter to allow the Company to define its manufacturing process and evaluate material characteristics. In addition, the initiation of stability studies will define product performance and support shelf-life considerations. These studies and data will provide information to confirm manufacturing readiness, which once achieved, will enable the transition to manufacture GMP PD-001 final product from the available GMP cepharanthine 2-HCL API materials. Manufacturing of the final product is scheduled for the first quarter of 2024. These materials will support potential Phase 1 and 2 clinical trials of PD-001 for oncology and infectious diseases. Downstream manufacturing efforts required to produce the orally bioavailable clinical drug product will also be completed by Genvion Corporation. The Company will commence working on a regulatory application to the TGA for an in human safety trial in Australia in the first quarter of 2024.
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.
The Company is focused on advancing the clinical development of an improved and patented enteric-coated oral formulation of cepharanthine (PD-001) to treat responsive cancers and COVID-19. 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. The Company 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 (including Covid-19) and rare cancers. Sairiyo is also conducting R&D in the psychedelics space for the treatment of non-neuropsychiatric conditions.