Clinical Study Begins Recruitment of Patients
Sydney, July 5, 2022 AEST (ABN Newswire) - VGI Health Technology Limited (
NSX:VTL) is pleased to announce that its wholly owned subsidiary, Invictus Ops Pty Ltd (Invictus), has commenced recruitment of patients for its Phase II clinical study in Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic SteatoHepatitis (NASH).
The study will enrol eighty patients across eight sites in Australia, with two sites The Gallipoli Medical Research Foundation (GMRF) in Queensland and The Royal Melbourne Hospital in Victoria now commencing recruitment of patients.
This study will be 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 noninvasive and direct delivery of tocotrienols using Invictus' patented transmucosal delivery platform.
Professor Darrell Crawford, the Director of Research for the GMRF, a Member of the Invictus Scientific Advisory Board 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 Administration in the US.
Invictus' 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) resulting from the inflammation."
"There is strong evidence from clinical studies conducted by other groups on orally-delivered tocotrienols which show promising signs of efficacy against NAFLD/NASH and we are of the view that Invictus' transmucosal delivery platform would enhance this efficacy" commented Dr David Kingston, Invictus' Chief Scientific Officer and Chair of the Scientific Advisory Board.
Additional study sites are expected to commence recruitment of patients shortly and Invictus is advancing preparations for a Phase II clinical study in Pancreatic Adenocarcimoma (pancreatic cancer) which is expected to commence recruitment of patients later this year.
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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