Two Human Trials on Medical Cannabis Receive Clearance in Australia
Medlab Clinical Ltd. has received the go-ahead from Australia’s Human Research Ethics Committee to begin human trials for two different cannabis-based medicines. It will be the first-ever clinical trial on medical cannabis for oncology patients who suffer from intractable pain.
The first medicine is NanaBis, an investigational new medicine that contains both THC and CBD and will be tested in cancer patients. The drug will be administered by NanoCelle, a nano-particle spray system that is applied inside the cheek. The second drug is NanaBidial, a CBD-based drug that is administered using the same delivery method.
Both medicines were developed at Medlab Clinical Ltd.’s laboratory located in Sydney, Australia. “NanaBis would meet a need globally for better pain management, with research having shown cancer pain was an increasingly widespread condition and generally undertreated,” Medlab CEO Sean Hall told AJP Online. “With the recent U.S. 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.”
The cannabis that will be used for the study will be sourced from Aphria Inc., a licensed Canadian medical cannabis producer. The company is waiting for one more clearance from Canadian health authorities before it can import the cannabis material.
Exhaustive human trials are required to form a basis for a Therapeutic Goods Administration (TGA) Special Access Scheme application in order to approve the drug for prescription by specialist doctors in Australia. Medlab’s trial is currently in Phase 0, and will begin by looking at the safety of individuals who consume the medicine for six months. There are many steps that Australia requires for medical cannabis-based products.
The trials will be conducted at the Royal North Shore Hospital’s Northern Sydney Cancer Centre. Professor Stephen Clarke, a medical oncologist and Professor of Medicine at the University of Sydney, will be leading the research study.
