ASX-LISTED life science company Medlab has received its first medicinal cannabis shipment from Canadian supplier Aphria.
The product has arrived at Medlab's schedule 8 Therapeutic Goods Administration (TGA) approved facility in Melbourne, representing the conclusion of the necessary health regulatory steps both in Australia and Canada for export and import of this important ingredient for a NSW Royal North Shore Hospital trial with advanced cancer patients suffering intractable pain.
This is the first commercial export from Aphria and the trial will be the first of its kind in the pain and oncology area.
Medlab anticipates that the trial drug NanaBis, which incorporates the company's patented nano-particle medicine delivery system, should be manufactured and delivered to Royal North Shore Hospital within six weeks.
NanaBis combines the two most active ingredients in cannabis, cannabidiol (CBD) and tetrahydrocannabinol (THC).
The trial, classified as a Phase 1 cross-over IIa trial, combining SAD (single ascending dose) and MAD (multiple ascending dose) studies, will be supervised by University of Sydney medical oncologist, palliative medicine specialist and Professor Stephen Clarke.
Separately, Medlab has also received approvals for commencement of a trial for a second cannabis-based medicine, NanaBidial which is a CBD only product intended to treat chemotherapy-induced nausea, vomiting and seizures.
Medlab says it expects to manufacture 3,500 units of NanaBis to sufficiently cover the trial cohort.
The company, which recently announced a strategic alliance with Heritage Brands (PD 14 Jul) is also applying its distinctive delivery system to other medicines, nutritional products and off-patent drugs like statins.
The above article was sent to subscribers in Pharmacy Daily's issue from 27 Oct 17
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 27 Oct 17
