The CARE NSW Clinical Trial will be assessing safety, tolerability and efficacy of different cannabis medicine formulations to provide symptom relief in advanced cancer patients.
The commercial supply agreement will generate revenues
Zelda’s managing director Richard Hopkins said: “We’re delighted for the opportunity to supply investigational product in the CARE NSW trial.
“The focus on studying cannabis as a strategy to potentially alleviate symptoms in advanced cancer patients is very much aligned to our strategic interests in this area.
“The commercial supply agreement also represents a significant milestone for our shareholders, as it is expected to generate the company’s first revenues from Zelda-branded TGA-TG093 compliant products.
“This is an important step towards commercialisation of Zelda’s own clinically validated products for sleep, chronic pain and anxiety, which the Zelda is expected to launch from 2020."
Trial based at University of Newcastle
The agreement is with the National Health and Medical Research Council (NHMRC)-funded Australian Centre for Clinical Cannabinoid Research Excellence (ACRE) based at the University of Newcastle.
The trial is formally known as the Cannabinoids for Symptom Control in Advanced Cancer, An Open Label Prospective Clinical Trial in NSW (CARE NSW).
Zelda is one of several suppliers selected to supply investigation product for the trial under a commercial contract.
Each patient will be prescribed a cannabis medicine from a defined selection of products currently available in Australia that are compliant with TG093 and GMP regulations.
The choice of study drug will be guided by the patient’s primary index symptoms and at the discretion of the doctor and supply.