Parents of Queensland children with severe drug-resistant epilepsy can now express their interest in taking part in medicinal cannabis clinical trials.
A new agreement between the Palaszczuk Government and UK-based pharmaceutical company GW Pharmaceuticals will facilitate a new research program for cannabis-based medicines for children with treatment-resistant epilepsy.
Minister for Health and Ambulance Services Cameron Dick said the signed Memorandum of Understanding (MOU) will allow up to 30 Queensland children from across the state access to Epidiolex through a compassionate access scheme.
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The number of children is restricted by the limited amount of product that can be obtained at this time.
“We have listened to Queensland families who are suffering and we are answering their calls to investigate this form of treatment,” Mr Dick said.
“This treatment has the potential to change lives.”
Epidiolex, a medicine developed by GW Pharmaceuticals, is a liquid form of pure cannabidiol.
A team of researchers from Lady Cilento Children’s Hospital will develop and lead the trials at a new specialist facility within the Queensland Centre for Children’s Health Research, co-located with the hospital.
This project will be led by Lady Cilento Children’s Hospital Director of Paediatric Neurosciences, Dr Geoff Wallace.
“By progressing these trials, we can shed light on what potential benefits this treatment can provide, and what conditions respond favourably and unfavourably,” Mr Dick said.
“We can’t cure severe treatment-resistant childhood epilepsy, but I want those children and their families to know that we are doing everything we can to ease their suffering.”
Mr Dick said the Palaszczuk Government had committed a total $6 million over three years to medicinal cannabis trials and the establishment of the specialist centre.
This investment bolsters one of the key aims of the government’s 10-year strategic plan My Health, Queensland’s Future: Advancing Health 2026 by promoting quality research and turning new ideas into practice.
“We hope to share the findings from our trial with New South Wales Health so that we can together ensure children battling drug-resistant epilepsy right across the country are receiving the best possible health care,” he said.
“Conducting our own trial here in Queensland means more children will have access to these innovative and advanced therapeutic drugs.
“This initiative is driven by our government’s compassion and the hope that it will offer relief to a number of children and their loved ones across Queensland.”
Those who believe they are eligible and are interested in trial participation can call 13 HEALTH from today to register an expression of interest, or talk to their treating doctor.
GW Pharmaceuticals Board of Directors Chairman Dr Geoffrey Guy said GW Pharmaceuticals had been working on the scientific application of cannabinoids for 18 years.
Epidiolex has shown positive results in a number of clinical trials in the United States.
“We are incredibly proud of the work our researchers have carried out to develop Epidiolex as a potential treatment within the field of childhood-onset epilepsy,’’ Dr Guy said.
“We have recently completed two successful Phase 3 clinical trials in the US and Europe in patients with Dravet syndrome and Lennox-Gastaut syndrome, two rare, extremely debilitating epilepsy syndromes that begin in infancy or early childhood.
“We now look forward to seeking regulatory approval for Epidiolex across the world.”
Not every child who takes part in the trial will obtain benefit, due to the complex nature of treating drug-resistant epilepsy.
Families will be advised if they meet the criteria and will be invited to take part in the trial.
Recruitment for the trials is likely to start on November 1 this year, and pending approvals, the trials should start by the end of 2016.