The trial will see patients given a specially prepared formulation, called Nanabis. It is made up of the two most well-known cannabis extracts, CBD (cannabidiol) and THC (tetrahydrocannabinol) and will be administered via the firm’s NanoCelle system - a tiny particle mouth spray for medicine.
Medlab managing director Sean Hall told the company’s recent annual general meeting that the trial would take place at Royal North Shore Hospital in Sydney under the supervision of Professor Stephen Clarke OAM, a medical oncologist, palliative medicine specialist and Professor of Medicine at the University of Sydney.
And today the company was granted a licence to import cannabis from the Australian Department of Health/Therapeutic Goods Administration (TGA).
Medlab managing director Sean Hall, said this was a significant milestone for the firm.
“It shows we have satisfied TGA requirements, allowing the import of a proprietary liquid cannabis blend which will be used in our clinical trial,” Mr Hall said.
Recent statistics regarding cancer pain indicate that it is prevalent in 64% of patients with metastatic or advanced stage disease and that for one in two patients with cancer, pain is undertreated, said the company.
The AGM also heard that Medlab achieved record nutraceutical sales in October, with September quarter 2016 sales up 20% on the previous quarter and 192% greater the corresponding quarter in 2015.
The firm said that sales growth has been assisted by new products and an expanded customer base, with sales expected to continue to grow over the next year.
It also updated investors are two other clinical trials. Following positive results from its phase 1 clinical trials for depression using its NRGBiotic probiotic, coenzyme Q10 and magnesium product, it is now ready to begin a phase 2a trial.
“The surrounding context for this development is that the World Health Organisation has predicted that by 2030, depression will account for the highest level of disability in the world,” said the company.
“Australian statistics indicate that over one million adults experience depression every year, with an estimated 45% of people experiencing a mental health condition in their lifetime.”
It will also soon publish “positive results” from its Phase 1 diabetes/obesity trial derived from MultiBiotic, which it says indicates significant reductions in insulin marker HbA1c, with a phase 2a study about to begin.
“Over the next 12 months, Medlab intends to pursue further research, commercialisation and growth, with it already in discussion with several parties regarding trade agreements,” the company told shareholders.
It reiterated: “Medlab expects Nanabis, Medlab’s pain management therapy derived from cannabis, to be introduced to the Australian market some time over the next 12 months.”
Earlier this month we reported that Australian manufacturer of pharmaceutical grade cannabis and hemp-based products Creso Pharma had sealed deals to launch its nutraceuticals in two European markets.