TORONTO, Sept. 30, 2021 /CNW Telbec/ - Braxia Scientific Corp. ("Braxia", or the "Company"), (CSE: BRAX) (OTC: BRAXF) (FWB: 496), a medical research company with clinics providing innovative ketamine treatments for persons with depression and related disorders, is pleased to report encouraging preliminary findings of a recent clinical study that suggests ketamine may be as effective as a standalone antidepressant, versus as an adjunctive therapy.
The study, which was conducted at the Canadian Rapid Treatment Centre of Excellence (CRTCE), a wholly owned Braxia subsidiary, showed comparable clinical benefits (e.g., antidepressant effects and reduction in suicidal thoughts) in a large sample of 220 patients with treatment-resistant depression (TRD) who received intravenous (IV) ketamine infusions as a monotherapy, as compared with those receiving IV ketamine in addition to oral antidepressants.
Following the study protocols, participants in the ketamine monotherapy group achieved response and remission rates of 39.1% and 17.4%, respectively. Meanwhile, those receiving ketamine treatment adjunct to antidepressants, saw corresponding rates of 21.9% and 6.7%.
"We continue to inform and refine treatment protocols on the implementation of ketamine for individuals with TRD," said Dr. Roger McIntyre, CEO, Braxia Scientific. "In many circumstances, persons who safely benefited from ketamine treatment were able to discontinue their ineffective conventional treatments and transition entirely to ketamine monotherapy. Additionally, this data further informs Braxia Scientific's drug discovery and development, especially as it relates to the appropriate patient selection and enrolment for our clinical research studies."
"Ketamine has been shown to provide rapid and significant antidepressant effects in individuals with unipolar and bipolar TRD, and can also rapidly reduce suicidal thoughts" said Dr. Joshua Rosenblat, Braxia Scientific's Chief Medical and Scientific Officer. "While these findings are preliminary, they support the idea that ketamine is a highly effective rapid-acting antidepressant treatment approach as evidenced by its ability to improve depression as a monotherapy. This data is particularly important, because it shows that the benefits of ketamine may not be dependent on the co-prescription of other medications."
According to the study, "Ketamine has been almost exclusively studied as an antidepressant adjunct to other antidepressants. Due to the dearth of high-quality clinical data on the safety and efficacy of ketamine as an antidepressant monotherapy, the majority of clinicians continue to prescribe ketamine to patients with the condition that they remain on a stable dose of one or more antidepressant drugs for the duration of treatment."
Dr. Rosenblat added, "The study provides real world evidence, from a large sample of persons treatment-seeking for TRD, that further advances the science and substantiates our research that ketamine is a safe, effective and rapid-acting treatment for depression, suicidality and other brain-based disorders."
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
The CSE has not reviewed and does not accept responsibility for the accuracy or adequacy of this release.
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.