June 2022 Quarterly Update
Sydney, July 29, 2022 AEST (ABN Newswire) - The Directors of VGI Health Technology Limited (
NSX:VTL) are pleased to provide the following update for the quarter ending 30 June 2022.
Status of Patent Ownership
On 4 April 2022, VGI Health Technology Limited was pleased to announce that the the United States Patent and Trademarks Office (USPTO) intends to grant a divisional patent for the 'Transmucosal Delivery of Tocotrienols' to its wholly-owned subsidiary Invictus Biotechnology Pty Ltd. Previously, a US patent directed to a method of treating post exercise muscle soreness or delayed onset muscle soreness (DOMS) by transmucosal administration of a tocotrienol was granted in June 2020. The present divisional patent application extends this coverage to pharmaceutical compositions containing delta tocotrienol 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 the US until 13 November 2032.
Technological and Product Development
On 21 March 2022, VGI Health was pleased to announce that Dr Jordan Moon, a member of its Scientific Advisory Board, will be presenting an abstract at the American Society for Nutrition (ASN) Annual Conference, Nutrition 2022. In association with the ASN, an abstract will be presented during the conference (14-16 June 2022) titled "Transmucosal delivery of tocotrienols from a delta-tocotrienol powder: A Multidose Pharmacokinetic study". The abstract describes some of the results that have been generated from a pharmacokinetics study conducted by Dr Moon in the US using new formulations developed for the transmucosal delivery of tocotrienols. These new formulations and methods of manufacture are also the subject of a new patent filing "PCT/AU2021/051449 - Transmucosal delivery of tocotrienols" made by VTL's whollyowned subsidiary Invictus Biotechnology Pty Ltd on 3 December 2021. The data from this study supports the fact that there is more flexibility with dosages for this particular drug delivery platform than earlier research data had suggested.
Sixteen healthy research subjects (m=8, f=8, 32 +/- 8 years, 171 +/- 7 cm, 81.6 +/- 13.8 kg) were randomly administered either 40mg or 80mg of a delta tocotrienol (DT3) containing powder in a fasted state. Subjects were asked to keep the powder under their tongue until it was fully dissolved.
Blood samples were taken at 0, 60, 90, 120, 180, 240, 360, and 480 minutes. Subjects were given a meal consisting of carbohydrates, proteins, and fats after four hours. DT3 concentrations were calculated from blood plasma using protein precipitation followed by liquid-liquid extraction.
Analytes were separated by Liquid Chromatography Mass Spectrometry (LCMS) with the extracts assayed against a calibration curve. DT3 bioavailability was assessed using the parameters peak plasma concentration (Cmax), time to reach peak plasma concentration (Tmax) and total area under the plasma concentration-time curve (AUC).
The plasma concentration of DT3 reached 44.05 ng/ml (Cmax) for the 40mg group and reached 127.4 ng/ml (Cmax) (+83.4 ng/ml increase) for the 80mg group. Tmax was achieved at 360 minutes for both the 40 and 80mg group. AUC for 40mg resulted in 9,941.6 ng/ml*min, with a +2.9 times increase observed in the 80mg group (29,072.2 ng/ml*min) compared to 40mg.
Transmucosal delivery of tocotrienols from a delta-tocotrienol powder containing 40mg and 80mg of DT3 resulted in a progressively elevated absorption rate for both doses with 80mg appearing to increase total plasma DT3 by a difference of +2.9 times that of a 40mg dose. Both 40 and 80mg doses of DT3 administered via transmucosal delivery have shown enhanced plasma DT3 concentrations in healthy men and women over a period of no less than 8 hours.
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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