Medlab Clinical Ltd (ASX:MDC) has formally launched the NanaBis™ observational study which will asses the use of NanaBis™ - a cannabis drug candidate being investigated for use in cancer pain management.
The study received ethics approval in June 2019 and will provide evidence, based on real world data, for safety, tolerability, use and potential adverse events as well as any potential impact on the patient while being prescribed other medicines.
Medlab chief executive officer Dr Sean Hall said “Medlab will be working closely with healthcare professionals to provide educational tools to better understand NanaBis™ as a treatment option for patients living with chronic pain.
“Participating patients will have access to medical cannabis at a significantly reduced price.”
Doctors will also be compensated for their participation in the study on a monthly, per-patient basis.
2,000 patients to be recruited for study
The study seeks to recruit 2,000 Australian patients via medical or hospital settings to provide intervention data over a 12-month period.
It is expected to provide for at least 700 patients diagnosed with cancer pain, with the remaining patient group to be classified as suffering noncancer pain.
During the soft launch, 125 doctors were enrolled along with 256 patients, roughly 12% of the final anticipated cohort.
All prescriptions in the study are effectively being made under the Australian government’s Special Access Scheme for the use of unapproved therapeutic goods.
Pathway to drug registration
The study, in conjunction with the recently completed phase two cancer pain trial at Royal North Shore Hospital in Sydney, is part of Medlab’s overall commitment to a clinical trials pathway to drug registration for NanaBis™.
The recently announced commercial agreement with Tasmanian Alkaloids Pty Ltd will allow Medlab to upscale manufacturing to cater to an increase in demand.
Medlab is currently developing protocols for a phase three trial to be used in Australia and the US.