“Securing Clinical Trial Authorisation solidifies over 16 months of hard work and dedication from our team and positions Halucenex as one of very few Canadian companies with approval to commence a clinical trial utilising psychedelic substances on mental health conditions,” president, CEO and founder Bill Fleming said.
Creso Pharma Ltd (ASX:CPH, OTCQB:COPHF)’s wholly-owned, Canadian-based psychedelics company Halucenex Life Sciences Inc. has secured Clinical Trial Authorisation (CTA) with Health Canada.
The CTA positions Halucenex as one of the few companies in Canada with clearance to begin a clinical trial utilising psychedelic substances.
Halucenex will now be able to progress the final steps towards the start of its planned phase II clinical trial to test the efficacy of psilocybin on treatment resistant Post Traumatic Stress Disorder (PTSD).
This is a major milestone for the Canadian company, which outlined its proposed trials objectives, design protocols and supporting data to Health Canada in January this year.
The January submission was subject to a 30-day review process by the regulator, prior to approval being granted.
