PharmaDrug Inc (CSE: PHRX) has laid the groundwork to support multi-kilogram production of cepharanthine-2HCL for use in the final drug production of PD-001 to treat responsive cancers and COVID-19.
PD-001 is the Toronto-based pharmaceutical company’s patented, oral, and bioavailable version of cepharanthine – a natural product and an approved drug used for more than 70 years in Japan.
It has already been proven to treat a range of acute and chronic diseases.
The key milestone achieved involved completing the sourcing and characterisation of bulk materials, preparation of reference standards and qualification of all necessary analytical methodologies.
PharmaDrug chief executive officer and chairman Daniel Cohen said the milestone achieved signals an important inflection point in the company’s preclinical and clinical development programs surrounding oncology and infectious disease.
“The sourcing and subsequent characterisation of bulk materials, including generic cepharanthine, followed by the preparation of cGMP calibre analytical methodologies as required by the FDA represents the majority of the effort in this initial cGMP production initiative,” he said.
“With these activities now complete, we are positioned to initiate the cGMP manufacturing run of our lead candidate PD-001.”
Pre-clinical and clinical development
Completion of this lot, slated for September 2022, advances PharmaDrug’s efforts to support pre-clinical and clinical development, including potential phase 2 clinical studies.
The company has called on Genvion Corporation to run ICH-compliant stability testing and forced degradation studies in support of future investigational new drug filings to the US Food and Drug Administration (FDA).
Genvion Corporation will take receipt of the cGMP drug substance and complete all manufacturing efforts necessary to produce PD-001.
Through clinical research, cepharanthine has shown to display multiple pharmacological properties, including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic effects.
Third-party studies have shown cepharanthine can inhibit cancer cell proliferation and induce cancer cell death.
In the past, cepharanthine’s low oral bioavailability has proven to be a major obstacle in realising its full clinical potential.
PharmaDrug is prioritising advancing the clinical development of its patented enteric-coated oral formulation of cepharanthine, PD-001, which will be used to treat responsive cancers and COVID-19.
Compared to traditional cepharanthine, PD-001 has been shown in rodent and non-rodent models to possess improved oral bioavailability.
PharmaDrug focuses on the research, development and commercialisation of psychedelics and other naturally-derived approved drugs.