Cepharanthine is a natural product and an approved medication used for more than 70 years in Japan to treat a variety of acute and chronic diseases. In clinical research, Cepharanthine exhibits multiple pharmacological effects including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic properties.
Despite compelling data to support the safe and effective use of cepharanthine for various ailments, broad adoption of cepharanthine has been hampered by the need to deliver it by way of frequent intravenous infusion to achieve sufficient circulating concentrations. PharmaDrug is developing PD-001, a novel highly bioavailable formulation of cepharanthine that can be delivered as an oral medication.
PD-001’s novel formulation provides a 10-fold increase in oral bioavailability over generic cepharanthine and opens the door to treating more patients, more conveniently in a pill format. Over 160 peer-reviewed manuscripts have highlighted the therapeutic potential of cepharanthine in treating a diverse range of cancers. Consistent with these findings, PharmaDrug intends to leverage existing safety and efficacy data to expedite the regulatory process associated with bringing PD-001 to patients suffering from serious types of rare cancers.
The Company intends to pursue a first-in-human study of its lead development candidate, PD-001, enteric coated cepharanthine-2HCL (for oral administration), in Australia during the second half of 2024. Development activities 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.
