The trial will test the safety, efficacy and dose tolerance in cancer patients.
Ltd () has commenced the trial of NanaBis™, its cannabis-based medicine for advanced cancer pain at Royal North Shore Hospital (RNSH) in Sydney.
The trial will test the safety, efficacy and dose tolerance in cancer patients with both managed and unmanaged pain.
Medlab managing director Dr Sean Hall said: “This is what we have been working towards.
“It’s a key milestone for the company, we have a validated GMP Australian manufactured product that is being used in a robust and much-needed trial.”
READ: on track for analytical release of Nanabis pain management medicine
Medlab is developing therapies for pain management, depression and obesity, and it is already earning revenue from the sale of nutritional products in Australia and the US.
Dr Hall added: “We are very proud of our research collaboration with both Prof Stephen Clark and the team at RNSH, we are hoping that this trial demonstrates efficacious alternatives to opioid use for this type of patient.”
Preparing for NanaBis drug application
The trial is expected to run over the next few months, with data available later in the year.
Importantly, the trial will form the basis of a NanaBis drug application being put before the Therapeutic Goods Association (TGA) and subsequent global regulatory agencies.
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