PharmaDrug Inc (CSE:PHRX, OTCQB:LMLLF) said it continues to advance its patented reformulated enteric-coated version of orally bioavailable cepharanthine (PD-001) as a potential treatment for oncology and infectious disease with the aim of commencing a regulatory application to the Australian Therapeutic Goods Administration (TGA) for an in human safety trial of the drug in the first quarter of 2024.
"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 States,” PharmaDrug CEO Robert Steen said in a statement.
The company said the technical transfer and development activities with Genvion are well underway as it prepares for the clinical GMP manufacturing of batches of PD-001 to support future regulatory filings.
Current development activities include establishing analytical testing methods and manufacturing protocols, and execution and performance assessment approaches for PD-001 active pharmaceutical ingredient (API) to support scale-up activities.
PharmaDrug said a feasibility batch of PD-001 will be manufactured during this quarter to allow the company to define its manufacturing process and evaluate material characteristics.
The company also intends to initiate stability studies to define product performance and support shelf-life considerations.
The manufacturing of the final product is targeted for the first quarter of 2024, and this will support potential Phase 1 and 2 clinical trials of PD-001 for oncology and infectious diseases, with the company to commence working on a regulatory application to the TGA for an in human safety trial at that time.
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.
Contact the author at emily.jarvie@proactiveinvestors.com
Follow her on Twitter @emilyjjarvie