Appointment of Clinical Study Site
Sydney, Sep 14, 2021 AEST (ABN Newswire) - VGI Health Technology Limited (
NSX:VTL) is pleased to announce that its wholly owned subsidiary, Invictus Ops Pty Ltd, has appointed Gallipoli Medical Research Foundation (GMRF) as a clinical study site for its multi-site Phase II Clinical Study in Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH). The study will seek to enrol eighty patients across eight sites in Australia. Seven of the eight sites have already been recruited.
Professor Darrell Crawford, the Director of Research for the GMRF and the Associate Dean, Strategic Development for the Faculty of Medicine for the University of Queensland, said "NAFLD/NASH is a difficult and intractable disease to treat and there are currently no treatments approved by major regulatory bodies such as the Therapeutic Goods Administration here in Australia or the Food and Drug Admnistration in the US. VTL's NAFLD/NASH drug candidate, IVB001, has the potential to address several aspects of this challenging disease including the steatosis (gathering of fat in liver cells), the inflammation caused by the steatosis and the fibrosis (scarring caused by collagen)."
The study VTL will be conducting is a randomised, double-blind, placebo-controlled Phase II clinical study on NAFLD/NASH to analyse the efficacy and safety of IVB001, a drug candidate based on the non-invasive and direct delivery of tocotrienols using the Company's proprietary and patented transmucosal delivery platform.
VTL, Professor Crawford and the Clinical Research Organisation managing this study, Datapharm Australia Pty Ltd, are expecting to submit a Human Research and Ethics Application for the study in the next few weeks, with a final clinical data readout for the study expected in Q1 of 2023.
Dr David Kingston, the Chief Scientific Officer and Chair of the Scientific Advisory Board of VTL, said "We are delighted to welcome an eminent research hepatologist such as Professor Crawford on board as the Principal Investigator for the GMRF clinical study site. IVB001 addresses multiple steps in NAFLD/NASH in a direct and non-invasive manner and presents an exciting opportunity to improve the lives of NAFLD/NASH patients."
About VGI Health Technology Limited
VGI Health Technology Limited (NSX:VTL) is an Australian public listed biotechnology company developing and commercialising novel dietary supplements and prescription medicines based on natural products (tocotrienols) which have wide therapeutic potential, including: Delayed Onset Muscle Soreness, muscle recovery, exercise endurance, Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic SteatoHepatitis (NASH), pancreatic cancer, hyperlipidaemia, hypertension and diabetes. VTL owns and controls patent and other intellectual property rights for novel approaches to non-invasively delivering tocotrienols directly to the target tissues. The Company has a product development program for evidence-based nutraceuticals and a clinical development program for prescription medicines.
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