PharmaDrug Inc announced that it has initiated the manufacturing of PD-001, a patented enteric-coated oral formulation of cepharanthine, for non-clinical and clinical studies in cancer and infectious diseases.
The company said that this comes after its recent announcements of the successful completion of its pre-Investigational New Drug (IND) meeting with the US Food and Drug Administration (FDA) regarding the proposed development of PD-001 for the treatment of mild to moderate coronavirus (COVID-19) and positive pre-clinical study results with PD-001 for esophageal cancer and other undisclosed cancers.
The current scale of manufacturing activities should fully support the development of PD-001 through IND-enabling studies and potential future FDA Phase 1 and 2a clinical studies.
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“We believe cepharanthine has tremendous potential to treat several indications,” Daniel Cohen, CEO of PharmaDrug said in a statement. “Following the completion of a successful pre-IND meeting with the FDA and ongoing studies in both rare cancers and COVID-19, we are confident we have a clear path to the clinic on a number of fronts."
Consistent with FDA requirements, a core battery of drug development activities need to be completed prior to initiation of human testing regardless of the disease indication under development, the company said.
As such, parallel development of PD-001 for oncology and infectious disease indications will provide valuable time and cost efficiencies to the company by way of eliminating the need to duplicate multiple standard activities.
One such place relates to drug manufacturing control and the need to reproducibly generate a sufficient quantity and quality of drug material to support all non-clinical and clinical testing. To that end, PharmaDrug has purchased a significant quantity of bulk cepharanthine material and has engaged Southwest Research Institute (SwRI) to initiate cGMP manufacturing activities in 1Q 2022, the company said.
SwRI has a previous track record for producing the company's drug substance and drug product according to required specifications
Following receipt of feedback from the FDA in November 2021 on its pre-IND application to treat COVID-19, the company said it is confident of its ability to simultaneously execute on both its PD-001 programs (COVID-19 and esophageal cancer) and that the drug product manufactured using existing methodology will yield material that complies with the rigorous standards set forth by the regulator.
PharmaDrug is focused on advancing the clinical development of an improved and patented enteric-coated oral formulation of cepharanthine (PD-001) to treat rare cancers and COVID-19. Compared to generic cepharanthine, PD-001 has been shown in rodent and non-rodent models to possess markedly superior bioavailability, the company said.
Contact Ritika at ritika@proactiveinvestors.com