In an Australian first, Zelda Therapeutics (ASX: ZLD) has been given the go ahead to begin its Australian medicinal cannabis trial for treating chronic insomnia sufferers.
“This has been a very rigorous process and has taken some time, but we are now very well positioned, and are the first to undertake a clinical trial of this nature in Australia,” Zelda executive chairman Harry Karelis said.
Zelda has now secured full approval from the Western Australian department of health as well as the Human Research Ethics Committee and the Therapeutic Goods Administration.
The WA Department of Health permit allows clinicians to prescribe the medicinal cannabis formulation for the trail, which has been manufactured in The Netherlands.
The trial is due to begin in the first quarter of 2018 and will be held at the University of Western Australia’s sleep centre, which has requisite research facilities.
“We are very pleased to have partnered with the leading researchers in this field and the prestigious UWA Centre for Sleep Science, and are confident this clinical trial will deliver the high-quality data we need to further develop and commercialise our medicinal cannabis formulation,” Mr Karelis said.
National Health and Medical Research Council research fellow Peter Eastwood will be directing the randomised and placebo controlled trial, which will be using Zelda’s medicinal cannabis formulation to treat chronic insomnia patients who have had difficulty falling and/or staying asleep for a prolonged period.
The sleep centre contains five bedrooms with “state of the art” sleep recording and analysis equipment.
According to Mr Eastwood, population-based data shows about a third of adults have difficulty falling or staying sleep.
“For this trial we have assembled a team of experts including sleep physiologists, sleep physicians and clinical psychologists,” Mr Eastwood added.
In addition to insomnia, Zelda is investigating the effect of its cannabinoid-based formulations on numerous medical conditions including autism, eczema and in breast, brain and pancreatic cancer.
For the cancer research, Zelda has teamed up with researchers from Spain’s Complutense University Madrid for pre-clinical testing to generate data for regulators and the pharmaceutical industry.