Receives Ethics Approval for US Clinical Study
Sydney, Sep 26, 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 received ethics approval to proceed with a US pharmacokinetics and exercise clinical study.
Institutional Review Board (IRB) approval was received by Invictus' research partner, Altipure R&D in Ohio, USA, to conduct a clinical study comprising 45 healthy volunteers to assess the bioavailability of delta tocotrienols (DT3) which have been administered via Invictus' transmucosal delivery platform. The study will also measure exercise performance and muscle power for two doses of Invictus' exercise performance nutraceutical product NE1-Elite(R) along with other endpoints such as lactate, glucose and lipids in the blood. Changes in muscle and fat mass will also be measured.
This clinical study will be led by VTL's Scientific Advisory Board Member Dr Jordan Moon, who said "We have seen some really exciting results which suggest that Invictus' transmucosal delivery platform can accommodate a far wider range of dosages than we had previously thought was possible. Now we want to see whether multiple higher doses administered over a period of time will translate to improvements in exercise performance".
Previously on 21 March 2022, Invictus reported on a clinical study led by Dr Moon showed that administering a single 80mg dose of DT3 via Invictus' transmucosal delivery resulted in plasma concentrations which were more than double those achieved with a 40mg dose. The present study will investigate the effect of transmucosal administration of multiple doses of DT3 over a period of 3 weeks.
Dr Glenn Tong, the CEO and Managing Director of VTL, said "While it is never wise to attempt to predict the results of a clinical study, we are quietly confident that data generated from Dr Moon's study will open up a great opportunity for new products both in our nutraceuticals and pharmaceuticals pipeline."
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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