Sydney, Australia, January 19, 2022 – (ABN Newswire) – The administrators of VGI Health Technology Limited (NSX:VTL) are pleased to provide the following update for the quarter ending December 31, 2021.

Patent ownership status

In October 2021, VTL is pleased to announce the grant of a divisional patent application by the Japan Patent Office which extends the coverage of the existing patent to pharmaceutical compositions containing delta tocotrienol and polyethylene glycol which have been formulated for a transmucosal administration. This composition can be used for the treatment or prevention of complementary indications such as fibrosis and cancer. Once granted, the patent officially titled “Transmucosal Delivery of Tocotrienol” will provide commercial rights in Japan up to November 13, 2032.

In December 2021, VTL was pleased to announce that its wholly owned subsidiary, Invictus Biotechnology Pty Ltd, had filed a new PCT patent application titled: “Transmucosal Administration of Tocotrienols” (PCT patent application number: PCT/AU2021/051449) with IP Australia (the Australian Patent Office). This new PCT patent application is derived from the provisional patent application filed on December 4, 2020 (provisional patent application number: AU2020904488). This patent application protects improvements in technology which are specifically directed to the transmucosal delivery of tocotrienols as an active pharmaceutical ingredient and improvements in the manufacture of such formulations.

The inventors of this patent are CEO and Managing Director of VTL, Dr. Glenn Tong, doctor David Kingston (Scientific Director of VTL and Chairman of the Scientific Advisory Board) and M. Richard Estalella, President and CEO of Invictus Nutraceuticals, Inc., a wholly owned US subsidiary of VTL. The subject of this new patent filing, improved transmucosal delivery of tocotrienols, provides protection against VTL’s drug candidates for non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH) IVB001 and pancreatic adenocarcinoma, IVB003. A phase II clinical study in NAFLD/NASH (IVB001) is expected to start in the first quarter of 2022, followed by a phase II clinical study in pancreatic adenocarcinoma (IVB003) which is expected to start in the second quarter of 2022.

Technology 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 of The Royal Melbourne Hospital (RMH) for a Phase II clinical study in non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH). The study will seek to enroll eighty patients at eight sites in Australia. Seven of the eight sites have already been recruited. The HREC RMH approved the VTL study for the RMH site and John Hunter Hospital location in New South Wales and patient enrollment is expected to begin in the fourth quarter of 2021. The study that VTL will conduct is a randomized, double-blind, placebo-controlled Phase II clinical study in NAFLD/NASH to analyze 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. (NAS:NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS(R)), announced the signing of a collaboration agreement between the wholly owned subsidiary of VGI Invictus Ops Pty Ltd and Endra to incorporate TAEU as an add-on technology to support patient screening and measurement of IGV biomarkers in the upcoming Phase II clinical study in non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH) of IVB001. By adding ENDRA’s economical and non-invasive solution TAEU technology to VTL’s clinical study protocol, it is expected to save time and money for the study through simpler, faster and non-invasive biomarker measurements of liver fat .

Customer Recruitment

During this quarter, the American subsidiary of VTL Invictus Nutraceuticals, Inc., has negotiated terms with a major online retailer for its nutraceutical products and this contractual agreement is expected to be executed within January 2022.

In regards to VGI Health Technology Limited:

VGI Health Technology Limited (NSX: VTL) is an Australian-listed biotechnology company that develops and markets novel dietary supplements and prescription medicines based on natural products (tocotrienols) that have broad therapeutic potential, including: delayed onset muscle pain , muscle recovery, exercise endurance, non-alcohol products Fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), pancreatic cancer, hyperlipidemia, hypertension and diabetes. VTL owns and controls patents and other intellectual property rights for novel approaches to the noninvasive delivery of tocotrienols directly to target tissues. The Company has a product development program for evidence-based nutraceuticals and a clinical development program for prescription drugs.

Contact :

Glenn TongCEO and Managing Director
Phone. : +61 (0) 412 193 350

Andrew CrookInvestor Relations and Media
Phone. :+61 (0) 419 788 431

Catriona GloverCompany Secretary
Tel: +61 (0) 402 328 200

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