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Zelda Therapeutics (ASX:ZLD) will supply an oil-based cannabis formulation to a wider 600-patient trial aimed at reducing pain for advanced cancer sufferers.
The New South Wales-based clinical trial will look to enrol up to 600 advanced cancer patients who will be prescribed a product selected from a range of cannabis medicines — and Zelda’s will be one of them.
It is hoped that suitable cannabinoid products or formulations to help manage pain symptoms will be found. It is being conducted at the University of Newcastle’s cannabis research centre.
Each patient will be prescribed a cannabis medicine from selection of products, all of which are currently available in Australia and are compliant with Therapeutic Goods Administration (TGA) and Good Manufacturing Practice (GMP) regulations.
It will depend on the individual patient’s presenting symptoms.
The cannabis products — to be either oil, THC or CBD — will be used in conjunction with standard treatments for advanced cancer and symptoms, including other medicines and radiotherapy.
“Its primary outcome is to assess efficacy of cannabis medicines on overall quality of life in patients with advanced cancer,” Dr Richard Hopkins, Zelda’s managing director, told investors.
“We’re delighted for the opportunity to supply investigational product in the 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 our first revenues from Zelda-branded products.
“This is an important step towards commercialisation of our own clinically validated products for sleep, chronic pain and anxiety, which we expect to launch from 2020.”
The agreement, however, does not have a minimum or maximum volume of the product, nor does it have a consistent frequency.