Latest news with #HREC
Yahoo
14-05-2025
- Health
- Yahoo
Glucotrack gains HREC approval for clinical study of CBGM device
Glucotrack has announced the receipt of St Vincent's Hospital Melbourne Human Research Ethics Committee's (HREC) approval for a multi-centre clinical study of its continuous blood glucose monitor (CBGM) in type 1 and type 2 diabetic patients. The single-arm, prospective study aims to assess the safety and performance of the device over a year, with potential extensions up to three years. It is set to enrol up to 30 subjects needing intensive insulin therapy and glucose monitoring. With the approval in place, Glucotrack will notify Australia's Therapeutic Goods Administration (TGA) before continuing with the enrolment process. The implantation procedure for the first subjects is expected to take place by July 2025. The CBGM is a long-term implantable system without a wearable component, tailored for continuous blood glucose monitoring for up to three years. It claims to directly measure glucose from blood, offering real-time readings and aiming to eliminate the lag time associated with interstitial glucose measurements. Australia's University of Melbourne professor David O'Neal will act as the study's principal investigator and oversee the research, alongside associate professor Neale Cohen from the Baker Heart and Diabetes Institute. The Glucotrack CBGM is limited by US federal law for investigational use only. The device's features include three-year sensor longevity, the absence of an on-body wearable component, and minimal calibration requirements. Glucotrack CEO and president Paul Goode said: 'Securing this approval represents a major milestone for our clinical programme and builds on the successful completion of our first-in-human study earlier this year. 'This year-long study will provide critical insights into the long-term performance, safety, and reliability of our innovative technology, which is designed to address key challenges identified by people with diabetes – including the need for extended sensor life, elimination of on-body wearables, and the benefits of direct blood glucose measurement.' The company designs, develops and commercialises technologies for diabetic people. In February 2025, the company completed a first-in-human study with its CGM that directly measures glucose levels from a blood vessel. "Glucotrack gains HREC approval for clinical study of CBGM device" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Associated Press
24-02-2025
- Business
- Associated Press
Ethics Board Approval Received for DehydraTECH-tirzepatide GLP-1 Study-Arm
5th study arm in 12-week Phase 1b Study receives lead clinical site approval KELOWNA, BC / ACCESS Newswire / February 24, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the 'Company' or 'Lexaria'), a global innovator in drug delivery platforms, announces it has received lead clinical site human research ethics committee ('HREC') approval that was required before dosing can begin in the 5th study arm of the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the 'Study') in Australia. This news complements similar news issued on November 13, 2024, when initial lead clinical site HREC approval was received for the first 4 arms of the Study. The Company is pleased to have received all of the necessary lead clinical site approvals so quickly. Additional HREC approval is still pending for the other clinical sites, which is expected soon. The Study is progressing with both patient recruitment and dosing. The milestone of First Patient First Dose occurred in December 2024 as planned. As a reminder, the 5 Study arms are as follows: Arm 1 - DehydraTECH-CBD capsules Arm 2 - DehydraTECH-semaglutide capsules Arm 3 - DehydraTECH-semaglutide combined with DehydraTECH-CBD capsules Arm 4 - Rybelsus® tablets (positive control) Arm 5 - DehydraTECH-tirzepatide capsules (with the newly received HREC approval) 'The ability to study two GLP-1 drugs - semaglutide and tirzepatide - in a single study that together comprise well over 90% of the global GLP-1 market is truly a remarkable achievement for a company of our size,' said Richard Christopher, CEO of Lexaria Bioscience Corp. 'Lexaria's ability to utilize our patented DehydraTECH delivery technology to potentially enhance performance characteristics of these drugs, along with our very own DehydraTECH-CBD, all the while utilizing oral dosing as opposed to injections, is a unique opportunity.' Further Study updates will be provided as and when available. About Lexaria Bioscience Corp. & DehydraTECH DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients enter the bloodstream through oral delivery. Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 48 patents granted and additional patents pending worldwide. For more information, please visit CAUTION REGARDING FORWARD-LOOKING STATEMENTS This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as 'anticipate,' 'if,' 'believe,' 'plan,' 'estimate,' 'expect,' 'intend,' 'may,' 'could,' 'should,' 'will,' and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Phone: 250-765-6424, ext 202
