Zelda Therapeutics Ltd has expanded a human clinical trial program to use cannabinoid medications in patients on chronic, high dose opioid pain management therapy.
This will see Zelda partner with St Vincent’s Hospital in Melbourne in a clinical trial partnership to examine the potential to use certain cannabinoid medications.
The joint clinical trial program is aimed at assisting patients who have become dependent on opioids for chronic pain management.
Managing director Dr Richard Hopkins said, “Zelda is delighted to work with the team at St Vincent’s, which continues our partnership activities with world-class institutes across the globe.”
Prescription opioids are used to treat chronic pain and these drugs can have serious side effects including physical dependence.
Research shows growing numbers of Australians receiving treatment for dependence on painkillers with the rate of accidental deaths due to opioids doubling for those aged 35 to 44 since 2007.
More than two-thirds of these deaths have been due to pharmaceutical opioids.
Dr Hopkins said: “While similar studies have been conducted in other countries with promising results, we believe that local medical community participation in these studies will accelerate acceptance of the potential of cannabinoid-based medicines.”
The clinical team will be led by Associate Professor Yvonne Bonomo, and includes Dr Jane Trinca, Professor David Castle and Dr Nigel Strauss.
An initial pharmacokinetic study will inform a small-scale 20 patient double-blinded, randomised, placebo-controlled study, with the potential to expand into a larger trial depending on results.
Protocols being finalised
Clinical trial protocols are being finalised and are expected to be lodged soon with the human ethics committee for review.
Subject to approvals, the trial would be expected to start in early 2019.
Trial medication will be sourced from Zelda’s strategic partner HAPA Medical for manufacture and supply of pharmaceutical-grade medicinal cannabis.
Should the trial results show benefits, Zelda expects to be able to supply the medicines to Australian patients via specialists registered under the Authorised Prescriber Scheme.
Zelda is focused on developing a range of cannabinoid-based formulations for the treatment of a variety of medical conditions.
Range of human clinical trials
The company is undertaking human clinical trials focused on insomnia, autism and opioid reduction with activities in Australia and the USA.
It is also undertaking pre-clinical research examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as research examining the potential for cannabinoids to treat diabetes-associated cognitive decline.