Aptorum Announces Publication of a Co-authored Paper on Development and Validation of a Sensitive Liquid Chromatography with Time-Of-Flight Mass Spectrometry Assay for In Vivo Pharmacokinetic Study of Epigallocatechin-gallate octaacetate (Pro-EGCG)
Nov 25th, 2022 8:00 EST
NEW YORK & LONDON & PARIS--(BUSINESS WIRE)--Regulatory News:
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) a clinical stage biopharmaceutical company dedicated to tackling unmet medical needs in oncology, autoimmune diseases and infectious diseases, is pleased to announce the recent publication of a joint effort for the validated analytical method developed for the determination of plasma pro-EGCG and its metabolites after oral administration using ultra performance liquid chromatography coupled to quadrupole time of flight mass spectrometry. This method was shown to be robust, rapid and sensitive which is a prerequisite for conducting in vivo pharmacokinetic studies.
The paper is titled, “Determination of (-)-epigallocatechin-3-gallate octaacetate and its metabolites in plasma of rats for pharmacokinetic study by ultra-performance-liquid-chromatography coupled to quadrupole-time-of-flight-mass-spectrometry” has been published in Frontiers in Pharmacology which can be downloaded at the following website address: https://pubmed.ncbi.nlm.nih.gov/36304154/.
Dr Thomas Lee, Head of Research and Development of Aptorum Group commented, “We are pleased to have this assay developed by The Chinese University of Hong Kong via our collaboration. Pro-EGCG is a prodrug of EGCG via octa-acetylation. As expected, it will be metabolized in multiple steps to EGCG and therefore monitoring of these metabolites at the same time is a major challenge. Heartfelt thanks to our collaborators, especially Prof. Ronald Chi Chiu Wang, at The Chinese University of Hong Kong, their hard work has translated to a sensitive, robust LC/MS assay which can monitor multiple Pro-EGCG and its metabolites in the plasma. Developing a sensitive assay is a necessary step before conducting in vivo IND-enabling studies such as GLP-compliant pharmacokinetic and toxicokinetic studies. We believe the same assay can be further optimized for eventual Phase 1 clinical trials in humans.”
About Aptorum’s Pro-EGCG Program
Pro-EGCG is a novel small molecule designed for oral administration as a potential non-hormonal based treatment for Endometriosis. The endometriosis condition is a painful disorder where the endometrial tissue grows outside the uterus, potentially affecting ovaries, fallopian tubes and pelvis tissue, in severe cases affecting fertility. It has been estimated that endometriosis affects c. 10% of reproductive age women and girls according to the World Health Organisation1.
About Aptorum Group
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a clinical stage biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutic assets to treat diseases with unmet medical needs, particularly in oncology (including orphan oncology indications), autoimmune and infectious diseases. Aptorum has completed two phase I clinical trials for its ALS-4 (MRSA) and orphan drug designated SACT-1 (Neuroblastoma) small molecule drugs and commercializing its NLS-2 NativusWell® nutraceutical (menopause). The pipeline of Aptorum is also enriched through (i) the establishment of drug discovery platforms that enable the discovery of new therapeutics assets through, e.g. systematic screening of existing approved drug molecules, and microbiome-based research platform for treatments of metabolic diseases; and (ii) the co-development and ongoing clinical validation of its novel molecular-based rapid pathogen identification and detection diagnostics technology with Singapore’s Agency for Science, Technology and Research.
For more information about the Company, please visit www.aptorumgroup.com.
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