Aphria ships cannabis oil to Australia for pain management trial

Canadian medical marijuana producer Aphria has completed its first shipment of cannabis oil to Australian medical life science company Medlab Clinical Limited.

The shipment is part of the previously announced agreement between Aphria and Medlab, in which Aphria will produce and supply high-yield cannabis extracts for Medlab to be used in its forthcoming human trial to test management of intractable pain in oncology patients — the first trial of its kind globally. The product formulation and permits have been approved by Health Canada and the Australian Therapeutic Goods Administration (TGA).

Sean Hall, CEO of Medlab, said, “This is an important step for Australian medical science as we prepare to begin our first clinical trial for advance cancer pain patients to help them manage their pain with a cannabis-based medicine. We’re grateful for the support of health authorities in Australia and Canada for this trial, which will provide scientific backing for the use of CBD and THC while giving the medical community confidence in its efficacy and safety.”

“The first shipment of medical cannabis to Medlab is part of our global expansion strategy to take the Aphria story to other regulated countries like Australia and create additional revenue streams,” said Vic Neufeld, CEO of Aphria.

“As Aphria’s first international partner, Medlab shares our vision to advance the use of medical cannabis as an alternative treatment for patients in need. We are proud to be a part of this important research, and we look forward to continuing to provide high-quality, safe and pure medical cannabis products to support Medlab’s clinical research and help patients effectively manage their pain.”

As part of the supply agreement, Aphria will grow and prepare the high-yield cannabis for Medlab in Canada and Medlab will complete the manufacturing at a licensed Schedule 8 (S8) TGA approved facility, located in Melbourne, Australia. At this facility, the cannabis product will be combined with Medlab’s patented medicine delivery system, NanoCelle, which enables submicron-sized particles to be taken by mouth spray, allowing a swifter and more direct absorption of medicine into the bloodstream. The end result will be the production of a precise, potent cannabis medicine for the human trial.

NanaBis, Medlab’s cannabis-based medicine, combines the two most active ingredients in cannabis, cannabidiol (CBD) and tetrahydrocannabinol (THC), and has received all approvals ready for the trial to commence at Kolling Institute of Medical Research, Royal North Shore Hospital, Sydney. The trial will be supervised by Professor Stephen Clarke OAM, a medical oncologist, palliative medicine specialist and Professor of Medicine at the University of Sydney. Medlab’s trial will be classified as a Phase 1 crossover IIa trial, combining SAD (single ascending dose) and MAD (multiple ascending dose) studies. Separately, Medlab has also received approvals for commencement of a trial for a second cannabis-based medicine, NanaBidial, which is a CBD-only product intended to treat chemotherapy-induced nausea and vomiting and seizures.

Medlab expects to manufacture 3500 units of NanaBis sufficiently covering the trial cohort.