Approval of New Clinical Study Site
Sydney, Feb 9, 2022 AEST (ABN Newswire) - VGI Health Technology Limited (
NSX:VTL) is pleased to announce that its wholly-owned subsidiary, Invictus Ops Pty Ltd, has received Human Research Ethics Committee (HREC) approval from a Lead Ethics Committee Site, Bellberry Ltd, for a Phase II clinical study on Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH) at the Gallipoli Medical Research Foundation (GMRF) in Queensland. This HREC approval will also cover other sites for this study, and together with the other Lead Ethics Committee approval from the Royal Melbourne Hospital (which also applies to The John Hunter Hospital in New South Wales and other sites) previously announced on 6 October 2021, this now paves the way for all of the clinical study sites to commence recruitment of patients in March. This study will enrol eighty patients across eight sites in Australia.
The study Invictus Ops Pty Ltd 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.
Dr David Kingston, VTL's Chief Sceintific Officer and Chair of its Scientific Advisory Board, said "This is a very exciting milestone for our NAFLD/NASH Phase II clinical study. As anyone who has conducted a clinical study would understand, an enormous amount of work is required to progress a study to when patients are about to be recruited and it is very satisfying to now be at this very important stage".
If left unchecked, NAFLD/NASH can progress to liver cirrhosis and liver cancer. At the present time, there are no approved treatments for NAFLD/NASH and many drug development efforts have failed, creating a great unmet need. The global market for NAFLD/NASH is expected to grow to about US$20-35B by 2025.
Dr Glenn Tong, the Chief Executive Officer and Managing Director of VTL, said "The GMRF and their Director of Research, Professor Darrell Crawford, have been an absolute pleasure to work with and we are delighted to share this exciting achievement of securing the HREC approval for this study with them."
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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