On August 19, 2024, PharmaDrug Inc. announced that its subsidiary, Sairiyo Therapeutics Inc., has received approval from the Australian Human Research Ethics Committee to commence a Phase 1 clinical study. The study will investigate a patented reformulated enteric coated version of oral cepharanthine (“PD-001”) for potential treatment in Medical Countermeasures and cancer. PD-001 was previously awarded a contract for the Ebola virus research. PharmaDrug’s CEO, Robert Steen, expressed enthusiasm for this milestone, highlighting the product’s potential in treating various diseases.
The completion of this study will support the submission of an Investigational New Drug application for PD-001 to the U.S. Food and Drug Administration (FDA) for further clinical trials. PD-001, a reformulated version of cepharanthine, aims to address limitations in its oral bioavailability to enhance its therapeutic benefits in managing infectious diseases and oncology applications.
Cepharanthine, a natural product with a long history of medical use, has demonstrated several beneficial properties, including anti-inflammatory and anti-cancer effects. PD-001’s improved bioavailability compared to generic cepharanthine is a significant development that eliminates the need for frequent intravenous dosing. The product is protected by a U.S. patent with an expiration date in 2036.
PharmaDrug Inc. is a specialty pharmaceutical company focusing on controlled substances and natural medicines. Through its subsidiary Sairiyo Therapeutics, the company is dedicated to researching and developing innovative drugs for a range of health conditions. Caution is advised regarding forward-looking information, as the company’s operations may be subject to various risks and uncertainties.
