CannPal Receives Ethics Approval for the Commencement of Clinical Trial in Dogs
- Ethics approval received for large pharmacokinetic and safety study in dogs
- CannPal’s lead drug candidate, CPAT-01, is being developed as a pain medication for companion animals
- The trial subjects will be evaluated for safety, tolerability and clinical observations using both psychoactive (THC) and non-psychoactive (CBD) cannabis compounds
- Over 48 dogs will be evaluated over the course of three phases, with results from phases 1 and 2 anticipated in Q2 2018
- The study will be run by Invetus Limited, Australasia’s largest veterinary research organization, in a state-of-the-art purpose built research facility in NSW
Animal health company CannPal Animal Therapeutics Limited (ASX:CP1) (“CannPal” or “the Company”) is pleased to announce it has received ethics approval for the commencement of a large clinical study for the Company’s lead drug candidate, CPAT-01, expected to begin Q1 2018 in Australia.
The approval is for phases 1 and 2 of CannPal’s first clinical trial involving dogs. The study is being carried out in a state-of-the-art veterinary research facility in New South Wales (NSW) which was purpose-built to house over 100 dogs for companion animal research.
CannPal adviser Dr Ted Whittem, who has guided over 30 veterinary drugs through the approval process as the head of research and development at Jurox, helped design the study which is being run in collaboration with Invetus, Australasia’s largest veterinary research organisation. Christine Budd, a veterinary surgeon at Invetus with over 24 years of experience, will run the study as principal investigator.
The trial is a comprehensive three-phase pharmacokinetic and safety study involving over 48 dogs that will assess the tolerability, safety profile and observational effects of tetrahydrocannabinol (THC), cannabidiol (CBD) and the Company’s proprietary cannabinoid formulation at different dosages. The ethics approval follows the pre-clinical research conducted by the Company leading up to its Initial Public Offering (IPO). The study is expected to being in Q1 2018 with results from phases 1 and 2 anticipated in Q2 2018.
CPAT-01 is being developed as a pain treatment for companion animals to provide a safe and efficacious alternative to Non-Steroidal Anti-Inflammatories (NSAID) which have a global market value of over US$1.4billion.
The ethics approval will allow CannPal to progress through the steps required to import, possess and supply cannabis oils for research and commence further trials in accordance with the Company’s schedule for early 2018. It also confirms that the trial is ethically acceptable and follows the guidelines set out by the APVMA (Australian Pesticides and Veterinary Medicine Authority) for research in animals.