Two medicinal cannabis trials to start
Trials of cannabis-derived medicines are hoped to have answers for cancer pain and nausea
Medlab Clinical Limited has received Human Research Ethics Committee approvals to begin human trials of two different cannabis-based medicines.
Developed at the medical life science company’s Sydney laboratory facility, the medicines have two different applications and will be clinically tested at different locations.
Medlab says the impending commencement of the trials will be a significant advancement for cannabis research globally.
The first medicine, NanaBis, is set to be clinically tested in advanced stage cancer patients with intractable pain.
The trial will be conducted at the Royal North Shore Hospital’s Northern Sydney Cancer Centre and will be supervised by Professor Stephen Clarke OAM, a medical oncologist, palliative medicine specialist and Professor of Medicine at the University of Sydney.
NanaBis will be administered by Medlab’s NanoCelle patented nano-particle spray to the inside of the cheek for quick absorption into the bloodstream.
The trial will be a safety, efficacy, tolerability and exploratory study into the medicine, which combines the two most active ingredients in cannabis, cannabidiol and tetrahydrocannabinol.
This would form the basis for a TGA Special Access Scheme application to enable prescription by specialist doctors.
The second medicine is NanaBidial, which comprises cannabidiol derived from marijuana.
It is indicated for chemotherapy-induced nausea and vomiting, with a secondary endpoint in patients suffering seizures, and will also be administered by NanoCelle.
The trial is a Phase 0 safety trial on healthy individuals with completion hoped for within six months; this would form the basis for a TGA Special Access Scheme application to enable prescription by GPs.
Medlab CEO Sean Hall says commencement of the trials is a significant breakthrough for Australian medicine.
“NanaBis would meet a need globally for better pain management, with research having shown cancer pain was an increasingly widespread condition and generally undertreated,” Mr Hall says.
“With the recent US crackdown on opioid abuse, there is a significant need for better, efficacious treatment.
“Our research with cannabis also indicates potential for other related conditions, creating a distinctive positioning for the research from a medical and market perspective.”
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