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Cardiol Therapeutics Receives Health Canada Approval for Phase 1 Study of its Pharmaceutically Produced Cannabidiol (CBD) Formulation
Oakville, Ontario--(Newsfile Corp. - March 5, 2020) - Cardiol Therapeutics Inc. ( TSX: CRDL...
About this update from Cardiol Therapeutics Inc. Class A
[{"type":"text","content":"Cardiol Therapeutics Receives Health Canada Approval for Phase 1 Study of its Pharmaceutically Produced Cannabidiol (CBD) FormulationStudy represents the first Canadian clinical trial of an oral pharmaceutical cannabidiol product specifically formulated for patients who should not be exposed to THCOakville, Ontario--(Newsfile Corp. - March 5, 2020) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) (\"Cardiol\" or the \"Company\"), a leader in the production of pharmaceutical cannabidiol (CBD) and the development of innovative cannabidiol medicines for heart diseases, has received a No Objection Letter from Health Canada to conduct a Phase 1 study of the Company's pharmaceutically produced (cGMP), high concentration, pure cannabidiol formulation that is THC free (<5ppm). The Company plans to initiate the study in Q2, 2020. Cardiol's Phase 1 study is designed to measure the pharmacokinetics (blood levels of drug) following single and multiple doses of the Company's extra strength 100mg/mL concentration pharmaceutical cannabidiol formulation in up to up to 55 healthy subjects, both in the fasting and fed states. The study will also measure standard safety parameters at escalating doses to help select the optimal dosing levels for the Company's planned international Phase 2 study in acute myocarditis, an inflammatory form of heart failure that represents a leading cause of sudden cardiac death in children and young adults. \"Receiving Health Canada's No Objection Letter to conduct a Phase 1 study is an important development for Cardiol, as this will be the first study designed to investigate safety and dosing levels of our high concentration cannabidiol formulation developed for patients who should not be exposed to THC,\" said David Elsley, President and CEO of Cardiol Therapeutics. \"The study is expected to provide important data to support the commercial and clinical development of this unique THC free (<5ppm) product which contains the same cannabidiol concentration as the medicine approved by the FDA for rare forms of paediatric epilepsy.\" There is a growing demand for a cannabidiol formulation that does not contain THC. Both the College of Physicians and Surgeons of Ontario and the Canadian Paediatric Society recommend that physicians do not expose young people under the age of 25 to THC, as its effects on brain d...