AUSTRALIAN-LISTED Medical life science company, Medlab Clinical Limited, has announced it has received Human Research Ethics Committee approvals by the Northern Sydney Local District, the Kolling Institute of Medical Research, Royal North Shore Hospital, to begin human trials of two different patent pending cannabis-based medicines.
The medicines are NanaBis, being trialled for advance stage cancer patients with intractable pain, and NanaBidial for chemotherapy induced nausea and vomiting.
NanaBidial will also have a secondary endpoint in patients suffering seizures.
NanaBis combines the two most active ingredients in cannabis, cannabidiol (CBD) and tetrahydrocannabinol (THC), while NanaBidial comprises cannabidiol (CBD) derived from marijuana.
The company said both drugs would be administered using Medlab's own patented nano-particle spray to the inside of the cheek, speeding the absorption of the medicine into the bloodstream.
Further, the clinical studies will establish Medlab's cannabis based intellectual property as a medicine, distinct from 'medicinal' cannabis, and help Medlab's path toward special access scheme approvals from TGA, a pre-requisite for medical practitioners being able to prescribe confidently.
University of Sydney Professor of Medicine medical oncologist and palliative medicine specialist Stephen Clarke will supervise the research program.
The NanaBis trial will be a safety, efficacy, tolerability and exploratory study, with proposed listing as a Schedule 8 drug permitting only medical specialists to prescribe the medicine intended for seriously ill cancer patients, the company said.
NanaBidial is intended to be made available to GPs, once approved.
Medlab is hoping for trial completion and market introduction by the end of 2018, should Special Access Scheme applications succeed.
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