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PharmaDrug's Sairiyo Therapeutics has filed a clinical trial application with the Australian Human Research Ethics Committee for a Phase 1 study of its patented reformulated cepharanthine (PD-001). This study will evaluate the bioavailability and pharmacokinetics of 30 mg and 60 mg enteric-coated capsules compared to 6 mg tablets in healthy volunteers. If approved in June 2024, this trial will be the first human test of PD-001, aimed at treating infectious diseases and oncology. Sairiyo's Australian subsidiary will sponsor the study. The initiative leverages Australia's drug development incentives, offering a 43.5% tax rebate. Successful completion may lead to FDA applications for further trials in the U.S.
PharmaDrug Inc. (CSE: PHRX) provides an update on its patent-pending biosynthetic cocaine manufacturing process, focusing on commercialization and safe supply programs. CEO Robert Steen outlines the strategic plan to accelerate commercialization, engage in global partnerships, and streamline regulatory processes. The company aims to deliver pharmaceutical-grade cocaine to meet increasing demand, with a focus on innovative production methods and market distribution for 2024.
PharmaDrug Inc. announces the appointment of Zalman Goldman to its board of directors, with a background in addiction and recovery, to advance the company's mission in drug research and commercialization. Concurrently, Nickolai Vassev resigns from the board. Mr. Goldman brings valuable experience to the company, receiving 500,000 stock options as part of his appointment.
PharmaDrug's Sairiyo Therapeutics has finished the clinical and regulatory package for a Phase 1 study of their reformulated cepharanthine in Australia. This patented drug, PD-001, aims to treat infectious diseases and oncology. Sairiyo will conduct the study in Australia to benefit from drug development incentives, planning to submit an Investigational New Drug application to the FDA afterward.