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Australian medicinal cannabis company AusCann (ASX: AC8) today announced it is preparing a trial of its proprietary cannabinoid-based formulations in people with spinal cord injury (SCI).
The company, which acquired CannPal Animal Therapeutics for $17.5 million earlier this year, has commenced the design phase for a clinical discovery trial to evaluate the efficacy of its cannabis-based medicine on those suffering from debilitating SCI.
It follows the completion of a technical assessment completed by the clinical research division of Cannvalate for the use of CBD and THC for symptoms associated with SCI.
The scope of that assessment addressed US Food and Drug Administration regulatory pathways, commercial feasibility, clinical trial mapping and the pathology and symptoms of people suffering from SCI - an underdeveloped area with an addressable market size of US$6 billion (AUD$8.2 billion).
AusCann says that following the completion of the Cannvalate assessment it has withdrawn from its previously planned investigator-led trial to redirect its resources to a research and development program that is “better designed to support product registrations in targeted medical conditions”.
“The aim of this discovery program is to generate clinical data on the benefits of the company’s proprietary cannabinoid-based formulations for people suffering from symptoms associated with Spinal Cord Injury, which may then be used to support a more extensive human drug development program for marketing approval via the U.S Food and Drug Administration,” says AusCann.
“The Company’s key medical advisors have seen encouraging benefits in patients with Spinal Cord Injury after the use of the Company’s Neuvis® THC/CBD oral capsule’s and will play a key role in shaping the design of the discovery program.”
The initial study will commence following approval by a human research ethics committee, with an initial submission from the committee expected to be made in early 2022.
Shares in AC8 are up 5.26 per cent to $0.10 per share at 10.11am AEDT.
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