VGI Health Technology : partners with ENDRA Life Sciences in NAFLD/NASH Phase II Clinical Study
11/28/2021 | 04:30pm EST
VGI Health Technology Limited
ABN: 35 111 082 485
Address: Level 45, MLC Centre, 19 Martin Place, Sydney NSW 2000
www.vgiht.com | Tel: +61 2 8279 8908
VGI Health Technology (NSX:VTL) partners with
ENDRA Life Sciences (NASDAQ:NDRA) in
NAFLD/NASH Phase II Clinical Study
VGI to include ENDRA's TAEUSⓇ technology in Phase II Clinical Study on NAFLD/NASH ofIVB001
Sydney New South Wales, 29 November 2021 - VGI Health Technology Limited (NSX:VTL), a clinical-stage biotechnology company wth delivery platforms for improving the bioavailability and efficacy of tocotrienols (a natural product which is one part of vitamin E) and ENDRA Life Sciences Inc.(NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), announced today 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.
"We are delighted to partner with VGI to help advance the clinical development of IVB001. It's clear that pharmaceutical companies and contract research organizations driving the NAFLD/NASH therapy pipeline face the same hepatic steatosis measurement challenges using MRI and liver biopsy as end-user clinicians. By adding ENDRA's cost-effective, non- invasive TAEUS technology to VGI's protocol, we expect to deliver time and cost savings for the study through simpler, faster and non-invasive biomarker measurements of liver fat," commented ENDRA's Chairman and Chief Executive Officer Francois Michelon. "In addition, we are excited to have the opportunity to expand and strengthen our global presence into Australia, which provides further opportunity to educate care providers and patients alike regarding the importance of both detection and treatment of this condition."
"VGI is excited to incorporate ENDRA's technology into screening for our Phase II study of IVB001, which targets NAFLD/NASH," said VGI's Chief Executive Officer and Managing Director Dr Glenn Tong. "After extensive discussions between Endra and VGI, we have come to the view that there is enormous potential value in capturing data on the degree of hepatic steatosis (the build up of fat in the liver) and other biomarkers to refine our understanding of systemic variables associated with NAFLD/NASH. We believe ENDRA's TAEUS system is uniquely designed to accomplish this task for us. VGI's focus on innovation, leads us naturally to explore new technologies like ENDRA's TAEUS that can lead to efficiencies in execution of our clinical studies," concluded Dr Tong.
In September 2015, a Phase Ia clinical study on IVB001 had positive topline data where all primary endpoints were achieved, including: confirmation of the bioavailability of the compound, with good plasma levels, dose relationship and duration of plasma levels achieved. Research from a number of groups using orally-delivered tocotrienols to treat NAFLD/NASH have shown promising results in improving liver function and bringing about favourable histological changes in NAFLD/NASH and this points to transmucosally delivered
VGI Health Technology Limited
tocotrienols like VGI's IVB001 having great potential to address this intractable disease where there is no approved treatment.
VGI Health Technology Limited (NSX:VTL) is an Australian public listed biotechnology company developing and commercialising prescription medicines and novel dietary supplements 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 clinical development program for prescription medicines and a product development program for evidence-based nutraceuticals.
ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS™), a ground-breaking technology being developed to visualize tissue like MRI, but at 1/50th the cost and at the point of patient care. TAEUS is designed to work in concert with the over one million ultrasound systems in use globally today. TAEUS is initially focused on the measurement of fat in the liver as a means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD) and inflammation (NASH), chronic liver conditions that affect over one billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS, including visualization of tissue temperature during energy-based surgical procedures. For more information, please visit www.endrainc.com.
VGI Health Technology Limited
All statements in this news release that are not based on historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "could," "seek," "intend," "plan," "goal," "estimate," "anticipate" or other comparable terms. Examples of forward-looking statements for ENDRA include, among others, estimates of the timing of future events and achievements, such as the expectations regarding commercializing the TAEUS device, establishing evaluation reference sites and initial sales in Europe, receipt of U.S. Food and Drug Administration ("FDA") regulatory approval, and expectations concerning ENDRA's business strategy, which may be affected by risks related to the impact of COVID-19 on its business plan, its ability to find and maintain development partners, market acceptance of its technology and the amount and nature of competition in its industry, its ability to protect its intellectual property, and other risks and uncertainties described in its filings with the Securities and Exchange Commission. Examples of forward-looking statements for VGI include, among others, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. The forward-looking statements made in this news release speak only as of the date of issuance, and ENDRA and VGI assume no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.
VGI Health Technology Ltd. published this content on 29 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 November 2021 21:29:04 UTC.