- Halucenex Life Sciences has partnered with Nucro-Technics to assess synthetic psilocybin’s efficacy in treatment-resistant Post Traumatic Stress Disorder (PTSD).
- With this agreement, the Company will develop and validate methods for potency, component identification, as well as microbiology for its botanical mushrooms.
- The proposed Phase 2 study will determine the feasibility of upcoming trials of psilocybin for Treatment-Resistant PTSD.
Creso Pharma Limited (ASX:CPH, FRA:1X8) has announced that Halucenex Life Sciences Inc. had entered into an agreement with Nucro-Technics to provide microbiology and chemistry test work for a salient delivery solution by using synthetic psilocybin, which Halucenex is planning to use in the upcoming clinical trial submissions. Creso had signed an agreement to acquire Canada-based Halucenex in March 2021.
Halucenex to assess the efficacy of psilocybin with Nucro-Technics
Under the agreement, Halucenex and Nucro-Technics will evaluate the stability and shelf life of liquid formulations of psilocybin for use in its Phase 2 clinical trial. Halucenex will have access to a Good Manufacturing Practice (GMP)-certified laboratory to prepare and assess its synthetic psilocybin compound.
Together, Halucenex and Nucro-Technics will evaluate psilocybin to:
Copyright © 2021 Kalkine Media Pty Ltd (Source: Source: CPH Announcement, 6 May 2021)
- The agreement will provide Halucenex with the ability to develop and validate methods for potency, component identification, as well as microbiology, for botanical mushrooms (psilocybe) grown at the Halucenex facility in the future.
- NucroTechnics will receive a fee of CA$38,202 for the services specified under the agreement.
- Halucenex can cancel the contract at any time by giving a written notice and payment of costs along with a reasonable cancellation fee agreed by both the parties.
Besides, as advised on 15 March 2021, Halucenex is waiting for Controlled Drugs and Substances Dealer’s License receipt from Health Canada. With the Dealers License receipt, Halucenex can apply for Clinical Trial Authorisation and start a Phase 2 clinical trial for the evaluation of psilocybin’s efficacy to treat Treatment-Resistant PTSD.
Nucro-Technics in a nutshell
- Nucro-Technics is a Canada-based leading pharmaceutical contract research organisation.
- The Canadian company partners with pharmaceutical, biologic, and medical device companies worldwide to assist with R&D initiatives.
- The group has been running for ~50 years and employs more than 170 personnel, who manage a state-of-the-art 60K square foot facility in Toronto.
- Nucro-Technics is compliant with multiple regulatory authorities, including Health Canada and the US FDA (Food and Drug Administration).
Proposed PTSD clinical trial
The proposed study will eventually evaluate the feasibility of upcoming trials of psilocybin to treat Treatment-Resistant PTSD.
The key highlights of the trial are-
- Phase 2 trial is designed as a single-arm, open-lab study.
- 18-20 individuals (over 18 years) suffering from Treatment-Resistant PTSD will be enrolled for the study.
- The trial is anticipated to start in the third quarter of 2021, depending on the receipt of the required regulatory authorisations.
Additionally, Halucenex, through its strategic adviser David Fraser, has an association with Veterans Affairs Canada (VAC). The relationship will accelerate the revenue generation via sales into a market with substantial demand and government support.
Mr Bill Fleming, Founder and the CEO of Halucenex, commented-
Adding to this, Adam Blumenthal, Non-executive Chairman of Creso Pharma, stated-
On 10 May 2021, CPH shares last traded at AU$0.190 (at AEST 10:44 AM).