Propanc Biopharma Executes Service Agreement with FyoniBio to Establish & Validate Pharmacokinetics Assay for Phase 1b First-In-Human Study

Core Insights - Propanc Biopharma, Inc. has entered into a service agreement with FyoniBio GmbH to establish and validate a liquid chromatography-mass spectrometry (LC-MS) based pharmacokinetics (PK) assay for its lead asset, PRP, aimed at advanced cancer patients [1][3] Company Overview - Propanc Biopharma, Inc. is focused on developing novel treatments for chronic diseases, particularly recurrent and metastatic cancer, by targeting cancer stem cells through proenzyme activation [4] Study Design and Objectives - The PK assay will measure the concentration of PRP and its analytes over time in advanced cancer patients, evaluating systemic concentration sufficient for anti-tumor activity while monitoring safety and tolerability [2] - Secondary efficacy endpoints will be observed to support treatment duration for responders, with the LC-MS PK assay designed to quantify analytes in serum with a sensitivity of at least 0.1µg/mL [2] Development Milestones - Establishing the PK method is one of three key activities in preparation for the First-In-Human study, alongside GMP manufacture of PRP and clinical trial application [3] - The company plans to commence the study in the fourth calendar quarter of this year, with confidence in the method development translating into a validated approach for decision-making [3]