Quarterly update
Sydney, Jan 19, 2022 AEST (ABN Newswire) - The Directors of VGI Health Technology Limited (
NSX:VTL) are pleased to provide the following update for the quarter ending 31 December 2021.
Status of Patent Ownership
In October 2021, VTL was pleased to announce the grant of a divisional patent application by the Japanese Patent Office which extends the existing patent coverage to pharmaceutical compositions containing delta tocotrienol and polyethylene glycol which have been formulated for transmucosal delivery. This composition can be used for the treatment or prevention of additional indications such as fibrosis and cancer. Once granted, the patent formally entitled 'Transmucosal Delivery of Tocotrienol' will provide commercial rights in Japan until 13 November 2032.
In December 2021, VTL was pleased to announce that its wholly owned subsidiary, Invictus Biotechnology Pty Ltd, had lodged a new PCT Patent Application titled: 'Transmucosal delivery of tocotrienols' (PCT patent application number: PCT/AU2021/051449) at IP Australia (the Australian Patent Office). This new PCT patent application is derived from the provisional patent application filed on 4 December 2020 (provisional patent application number: AU2020904488). The present patent filing protects improvements to the technology which are specifically focused on the transmucosal delivery of tocotrienols as the Active Pharmaceutical Ingredient and improvements in the manufacture of these formulations.
The inventors on this patent are the CEO and Managing Director of VTL, Dr Glenn Tong, Dr David Kingston (VTL's Chief Scientific Officer and Chairman of the Scientific Advisory Board) and Mr Richard Estalella, the President and CEO of Invictus Nutraceuticals, Inc., a wholly owned US-based subsidiary of VTL. The subject of this new patent filing, the improved transmucosal delivery of tocotrienols, offers protection over VTL's drug candidates for Non-Alcholic Fatty Liver Disease (NAFLD)/NonAlcoholic Steatoheaptitis (NASH) IVB001 and pancreatic adenocarcinoma, IVB003. A Phase II clinical study on NAFLD/NASH (IVB001) is expected to commence in Q1 of 2022 followed by a Phase II clinical study on pancreatic adenocarcinoma (IVB003) which is expected to commence in Q2 of 2022.
Technological and Product Development
In October 2021, VTL was pleased to announce that its wholly owned subsidiary, Invictus Ops Pty Ltd, has received Human Research Ethics Committee (HREC) approval from The Royal Melbourne Hospital (RMH) for a Phase II clinical study on 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. The RMH HREC has approved VTL's study for both the RMH site and The John Hunter Hospital site in New South Wales and recruitment of patients is expected to commence in Q4 of 2021. 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.
In November 2021, VTL and ENDRA Life Sciences Inc. (NASDAQ:NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS(R)), announced the signing of a collaboration agreement between VGI's wholly owned subsidiary Invictus Ops Pty Ltd and Endra to incorporate TAEUS as an add-on technology to support VGI's patient screening and biomarker measurement during the upcoming Phase II clinical study on Non-Alcoholic Fatty Liver Disease/Non-Alcoholic Steatohepatitis (NAFLD/NASH) of IVB001. By adding ENDRA's cost-effective, non-invasive TAEUS technology to VTL's clinical study protocol, it is expected to deliver time and cost savings for the study through simpler, faster and non-invasive biomarker measurements of liver fat.
Customer Recruitment
During this quarter, VTL's US subsidiary Invictus Nutraceuticals, Inc., has negotiated terms with a major online retailer for its nutraceutical products and this contractual agreement is expected to be executed in January 2022.
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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