Medical life science company, Medlab Clinical (ASX:MDC), has received a licence to import cannabis.
The company said the licence, granted by the TGA, represents a critical step towards commencing a clinical trial using cannabis for patients suffering intractable cancer pain.
Medlab Managing Director, Mr Sean Hall, said it is a significant milestone for Medlab.
“It shows we have satisfied TGA requirements, allowing the import of a proprietary liquid cannabis blend which will be used in our clinical trial,” he said.
“It also means we can look at starting manufacture of NanoCelle Cannabis, which we’ve named Nanabis and which will be the delivery mechanism for administering our cannabis formulation in nano-sized particles by mouth.
“With the TGA approval and this being advised to Royal North Shore Hospital, we are entering the final stages of meeting requirements for ethics approval for the clinical trial.
“Ethics approval and ultimate issue of a clinical trial number from TGA are final pre-requisites for the trial to begin, but with cannabis import approval achieved, indications are the trial should begin earlier than previously indicated, and hopefully this year,” said Mr Hall.
Medlab will import the proprietary cannabis blend from Canada, through a licenced producer of medical marijuana, Aphria, completing the final product at a specialised pharmaceutical facility in Melbourne.
Cannabis plant species, yields and a novel extraction process have been established in collaboration between Medlab and Aphria, allowing Aphria to produce large scale supply for Medlab.
Medlab’s clinical trials at Royal North Shore Hospital in Sydney will be supervised by Professor Stephen Clarke OAM, a medical oncologist, palliative medicine specialist and Professor of Medicine at the University of Sydney.
