PharmaDrug Inc (CSE: PHRX) has established the foundation to support the production of multi-kilograms of cepharanthine-2HCL for the final drug production of PD-001, aiming to treat responsive cancers and COVID-19.
PD-001 is a patented oral and bioavailable version of cepharanthine developed by the Toronto-based pharmaceutical company. Cepharanthine is a natural product and an approved drug with over 70 years of use in Japan, demonstrating efficacy in treating various acute and chronic diseases.
An important milestone was achieved by PharmaDrug through the completion of sourcing and characterisation of bulk materials, preparation of reference standards, and qualification of necessary analytical methodologies. This milestone signals a significant advancement in the company’s preclinical and clinical development programs focused on oncology and infectious diseases, according to PharmaDrug CEO and chairman Daniel Cohen.
The next step for PharmaDrug is to initiate a cGMP manufacturing run of PD-001, with completion of this lot expected by September 2022. This progress will further support pre-clinical and clinical development, potentially leading to phase 2 clinical studies. Genvion Corporation has been engaged to conduct ICH-compliant stability testing and forced degradation studies in preparation for future investigational new drug filings with the FDA.
Cepharanthine has demonstrated various pharmacological properties through clinical research, such as anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral, and anti-parasitic effects. Third-party studies have shown its ability to inhibit cancer cell proliferation and induce cancer cell death. PharmaDrug aims to overcome cepharanthine’s low oral bioavailability by advancing the clinical development of PD-001, its patented enteric-coated oral formulation designed for responsive cancers and COVID-19 treatment.
PharmaDrug’s focus is on researching, developing, and commercializing psychedelics and other naturally-derived approved drugs.
