Halucenex Life Sciences Inc. targets Australian market following landmark TGA decision

The wholly-owned Creso Pharma subsidiary is currently conducting clinical trials of its synthetic psilocybin formulation as treatment for mental health conditions

NEDLANDS, Australia, Feb. 8, 2023 /PRNewswire/ -- Creso Pharma Limited (ASX:CPH, FRA:1X8) ('Creso Pharma') is pleased to announce its wholly-owned psychedelics subsidiary, Halucenex Life Sciences Inc. ('Halucenex'), is exploring opportunities to register its synthetic psilocybin formulation for the Australian market following recent regulatory changes.

The Therapeutic Goods Administration (TGA), the medicine and therapeutic regulatory agency of the Australian Government, recently announced that the medical use of MDMA and psilocybin will be reclassified from Schedule 9 (prohibited substances) to Schedule 8 (controlled medicines). This ruling allows authorized psychiatrists to prescribe medicines containing MDMA and psilocybin for the treatment of certain mental health conditions as of July 1, 2023.

Based in Windsor, Nova Scotia, Halucenex is currently undertaking a Phase II clinical trial which will test the efficacy of psilocybin on treatment-resistant PTSD. The company has recruited 20 patients from the single-arm, open-lab trial that all suffer from the condition, in addition to other mental illnesses such as, but not limited to, anxiety, suicidal thoughts, ADHD, depression and anger.

Creso Pharma is confident that the data generated from the Halucenex trial will provide a strong foundation for the registration of the company's Lucenex-branded synthetic psilocybin product as a potential treatment option in Canada and Australia, pending further regulatory requirements. Halucenex is already a Licensed Psilocybin Supplier under Health Canada's Special Access Program.

"This is a watershed moment for psychedelic therapy in Australia," said Creso Pharma CEO and Managing Director William Lay. "The TGA's decision provides considerable validation of Halucenex's work to date, and it highlights the significant potential Creso Pharma has as an early stage pioneer of medical psilocybin."

"Halucenex's clinical trial is advancing pleasingly," continued Lay. "We are confident that data generated from the initiative will provide a much greater insight into how Lucenex can be used as a potential treatment route for debilitating health conditions."

Creso Pharma and Halucenex will continue to work alongside Australian-based research organizations and potential partners to further progress these initiatives.

About Creso Pharma Limited

Creso Pharma Limited (ASX:CPH) brings the best of cannabis to better the lives of people and animals. It brings pharmaceutical expertise and methodological rigor to the cannabis world and strives for the highest quality in its products. It develops cannabis and hemp derived therapeutic, nutraceutical, and lifestyle products with wide patient and consumer reach for human and animal health.

Creso Pharma uses GMP (Good Manufacturing Practice) development and manufacturing standards for its products as a reference of quality excellence with initial product registrations in Switzerland. It has worldwide rights for a number of unique and proprietary innovative delivery technologies which enhance the bioavailability and absorption of cannabinoids. To learn  more please visit: www.cresopharma.com.

Creso Pharma offices:

Australia
Suite 5 CPC, 145 Stirling Hwy, Nedlands, WA, 6009

Switzerland
Allmendstrasse 11, 6310 Steinhausen, Schweiz

Canada
59 Payzant Drive, Windsor, Nova Scotia, B0N 2TO and 50 Ivey Ln, Windsor, Nova Scotia, B0N 2TO

About Halucenex Life Sciences Inc.
Bridging the gap between nature and pharmaceuticals, Halucenex is a life sciences development company with a focus on researching novel psychedelic compounds, developing and licensing psychedelic compounds for the pharmaceutical and nutraceutical markets, and conducting clinical trials on the medical benefits of psychedelic medicine. For more information, please visit:  www.halucenex.com.

Forward-Looking Statements:
This announcement contains forward-looking statements with respect to Creso and its respective operations, strategy, investments, financial performance and condition. These statements generally can be identified by use of forward-looking words such as "may", "will", "expect", "estimate", "anticipate", "intends", "believe" or "continue" or the negative thereof or similar variations. The actual results and performance of Creso could differ materially from those expressed or implied by such statements. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding future expectations. Some important factors that could cause actual results to differ materially from expectations include, among other things, general economic and market factors, competition and government regulation.

The cautionary statements qualify all forward-looking statements attributable to Creso and persons acting on its behalf. Unless otherwise stated, all forward-looking statements speak only as of the date of this announcement and Creso has no obligation to up-date such statements, except to the extent required by applicable laws.

SOURCE Creso Pharma