- Receives ethics approval from Human Research Ethics Committee for Single Ascending Dose PK study
- Completing subject enrolment; initiation expected in June 2015
- Data expected August 2015 and final Report Q4, 2015
MELBOURNE, Australia, May 27, 2015 (GLOBE NEWSWIRE) -- Gordagen Pharmaceuticals, a privately-held company commercializing evidence-based nutraceuticals and pharmaceuticals, today announced that it has received approval from Bellberry Limited, Australia's National Human Research Ethics Committee (HREC) to commence its Phase I study of natural tocotrienols.
The Single Ascending Dose ("SAD") study will assess the safety, tolerability and plasma PK for Gordagen's tocotrienol tablet formulation based on the Company's proprietary "melt-then-swallow" technology (MELT3TM).
The design of this Phase I clinical study is applicable across all of Gordagen's target indications, and may eliminate the need for subsequent Phase I studies as the Company develops the product for additional indications. The SAD study aims to enrol up to 60 healthy subjects at a Western Australian trial site, with dosing expected to begin in early June 2015.
"We are very excited to be starting our SAD clinical study as this is a significant milestone for the Company. We have placed tremendous thought into the design of the program through our highly experienced scientific and clinical advisors, and we are confident in our ability to expeditiously advance the development of these products," said Dr. Glenn Tong, Managing Director & CEO of Gordagen.
The SAD PK clinical study is an open randomized controlled trial (RCT) consisting of 4 cohorts of 12 subjects (MELT3TM arms) and 2 cohorts of 6 subjects (oral arms). It will compare several different doses of Gordagen's tocotrienol tablet formulation, administered either orally or via Gordagen's proprietary "melt-then-swallow" (MELT3TM) technology, in fed and fasted states. The study will be completed within 30 days, and the final Clinical Study Report is expected by Q4 2015.
The Company plans to initiate a Multiple Ascending Dose (MAD) PK study following the SAD study. Collectively, the SAD and MAD clinical studies will provide valuable bioavailability information regarding Gordagen's tocotrienol tablet formulation and establish the foundation for the planned Phase II clinical trial program.
Gordagen intends to conduct its Phase II clinical studies in exercise performance and recovery in 2016 at leading Sports, Exercise and Nutrition Universities in Australia.
The Company has engaged Unison Nutraceuticals, which has pending cGMP status and a strong track record of manufacturing high quality nutraceuticals, to manufacture tablets for both clinical research and commercial sample.
Dr. Tong added, "Our goal is to commercialize evidence-based nutraceutical products, and Gordagen will only make claims for its products that are supported by robust ICH-GCP clinical evidence. We believe that this approach will be a key differentiator for the Company and our products in the nutraceutical and dietary supplement space."
Gordagen is working toward registration of its MELT3TM product in 2016 and the launch of its exercise endurance and muscle soreness nE1-ElitETM dietary supplement globally in 2017.
About Gordagen Pharmaceuticals Pty Ltd
Gordagen Pharmaceuticals is a privately-held Australian company developing and commercialising novel supplements and prescription medicines based on natural tocotrienols, found in vitamin E. The Company has developed a novel approach to delivering highly potent tocotrienols to target tissues using its proprietary and patent-pending "melt-then-swallow" delivery technology (MELT3TM). The Company is focusing on tocotrienols with wide therapeutic potential, for the treatment of heart health, muscle soreness and exercise endurance.
CONTACT: Investor and Media Enquiries: Company Dr Glenn Tong Managing Director & CEO Tel: +61 (0) 412 193 350 Australia Paris Brooke Bt Novo Pty Ltd Tel: +61 (0) 407 715 574 United States David Burke The Ruth Group O: 646.536.7009 C: 917-618-2651Source:Gordagen Pharmaceuticals