- First multiple-dose psilocybin clinical trial will be conducted at Braxia Health’s Canadian Rapid Treatment Centers
- Trial will include adults with treatment-resistant depression and will also enroll adults who have previously tried electroconvulsive therapy and/or intravenous ketamine
TORONTOAug. 27, 2021
“This will be the broadest study of its kind,” said Dr. Joshua Rosenblat , the trial’s principal investigator and medical director of the Canadian Rapid Treatment Centre of Excellence Inc. (CRTCE), a wholly owned subsidiary of Braxia Scientific.
“Whereas most other treatment-resistant depression (TRD) studies limit participation to patients that have not found relief from a maximum of five other potential remedies, our research will not have an upper limit, and will even include patients that have endured dozens of unsuccessful medical trials, including ketamine and electroconvulsive therapy.
“By including everyone with more than two failed medical trials, we are increasing the degree to which the results can be applied to a larger population, making our findings much stronger. Furthermore, we will have less exclusion criteria and are even including patients with bipolar depression – a huge first for the field – or comorbid disorders, which were excluded in psilocybin studies done by other companies.”
Braxia Scientific CEO Dr. Roger McIntyre added, “Integrating psilocybin provides immense opportunity for benefit for those dealing with treatment-resistant depression. Unfortunately, over one-third of the more than 300 million people suffering with depression worldwide fail to adequately respond to currently approved treatments, and thus the TRD market is very large and disproportionately dominates the majority of mental health services.”
The study will demonstrate that the Company can effectively conduct a randomized controlled trial using psychedelic-assisted therapy. This will enable the Company to build the infrastructure for future studies and future clinical care, while also compiling efficacy data and providing the opportunity to evaluate the therapist training program launched at the end of June 2021 .
This program run by the Braxia Institute, the Company’s training centre focused on advancing psychiatric clinical practice and health services of ketamine and psychedelic treatment therapy, has already cultivated a multi-disciplinary group of 20 therapists from diverse psychiatry and psychotherapy backgrounds to implement safe and effective psilocybin-assisted therapy for patients with depression.
Today’s announcement is the latest step in Braxia Scientific developing the next generation of novel psychedelic treatments and delivery systems through its network of clinics.
About Braxia Scientific Corp.
Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders. Through its medical solutions, Braxia aims to reduce the illness burden of brain-based mental disorders such as major depressive disorder among others. Braxia is primarily focused on (i) owning and operating multidisciplinary clinics, providing treatment for mental health disorders, and (ii) research activities related to discovering and commercializing novel drugs and delivery methods. Braxia seeks to develop ketamine and derivatives and other psychedelic products from its IP development platform. Through its wholly owned subsidiary, the Canadian Rapid Treatment Center of Excellence Inc., Braxia currently operates multidisciplinary community-based clinics offering rapid-acting treatments for depression located in Mississauga, Toronto, Ottawa, and Montreal.
ON BEHALF OF THE BOARD
“Dr. Roger S. McIntyre “
Dr. Roger S. McIntyre
Chairman & CEO
Website: www.braxiascientific.com
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Forward-looking Information Cautionary Statement
This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance are “forward-looking statements”. Forward-looking statements include statements about the intended promise of ketamine-based treatments for depression and the potential for ketamine to treat other emerging psychiatric disorders, such as Bipolar Depression. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events, or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the failure of ketamine, psilocybin and other psychedelics to provide the expected health benefits and unanticipated side effects, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and engaging in activities that could be later determined to be illegal under domestic or international laws. Ketamine and psilocybin are currently Schedule I and Schedule III controlled substances, respectively, under the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (the “CDSA”) and it is a criminal offence to possess such substances under the CDSA without a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug for any indication, however ketamine is a legally permissible medication for the treatment of certain psychological conditions. It is illegal to possess such substances in Canada without a prescription. These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, including the Amended and Restated Listing Statement dated April 15, 2021, which are available at www.sedar.com . There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements.
