Ehave Hires Contract Research Organization To Conduct Ketamine Clinical Trial In Miami, Florida
Ehave, based in Miami, has initiated a ketamine clinical trial aimed at exploring the potential of ketamine to promote neuroplasticity and address mental health issues. The company has engaged KGK Science Inc. to develop the necessary protocol and Informed Consent Form for its Institutional Review Board application. The trial will involve four ketamine infusions for each patient, with the goal of obtaining objective data to support the treatment's effectiveness for depression and related conditions. Ehave also plans to expand its KetaDASH platform to enhance mental health care.
- Initiation of a clinical trial with ketamine, which may lead to advancements in treating depression.
- Engagement of KGK Science Inc. for protocol development, aiding in clinical efficiencies.
- Potential for significant patient impact, with reports of long-term relief from symptoms in existing patients.
- Ketamine treatments are not yet approved by the FDA for depression, indicating regulatory hurdles.
- Market competition in the psychedelic and mental health sectors may pose challenges.
Ehave one of the first companies to pioneer the collection of certain data points, as well as to seek to understand how ketamine can potentially resolve issues in the brain through a process called neuroplasticity
MIAMI, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Ehave, Inc. (OTC Pink: EHVVF) (the “Company”), a provider of digital therapeutics for the psychedelic and mental health sectors, announced today it has hired KGK Science Inc., a contract research organization (CRO) that is wholly-owned by KetamineOne Capital Limited (NEO: MEDI) (OTC: KONEF) (Frankfurt: MY0), to develop the protocol and Informed Consent Form (“ICF”) to support its Institutional Review Board application. CROs are designed to reduce costs for companies developing new medicines and drugs in niche markets, and they aim to simplify entry into drug markets. Ehave has engaged the CRO for a ketamine clinical trial that will be conducted within its medical facilities located in Miami, Florida.
Ehave will be one of the first companies to collect certain data points and seek to understand how ketamine can potentially resolve issues in the brain through a process called neuroplasticity. The required protocol and ICF for the clinical trial are being developed in accordance with the guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. The CRO will provide a cover letter to support the clinical trial that is being planned to go through an alternate route to the more traditional Investigational New Drug application.
“The results and feedback from the Ketamine patients in our practice have so far exceeded my expectations. I believe that we are on the verge of curing, as opposed to simply treating, certain psychiatric maladies. We have clients who, after receiving eight ketamine IV treatments, are going on two years without a return of their depression, anxiety, PTSD and neuropathic pain. Through the upcoming clinical trial, Ehave’s goal is to produce objective evidence to support my belief,” stated Dr. Jeffrey Kamlet, Chief Medical Officer of Ehave.
The purpose of the study will be to obtain objective data to support the belief that the proper dosing and administration of intravenous (“IV”) Ketamine treatments can result in neuroplasticity and sustainable relief from depression, with or without PTSD. Study patients are proposed to each receive four ketamine infusions. In association with the third party, the clinic operator is proposing that the ketamine-centered study will measure patients before, during, and after their IV Ketamine infusions.
Ehave’s KetaDASH is a personalized mental care platform designed to instantly connect patients with highly skilled nurses to provide ketamine therapy at home under expert supervision. The KetaDASH platform will include software, staffing, protocols, and equipment. Ketamine is currently used to help ease pain and allows sedatives to be effective at lower doses, lessening the amount of potentially addictive pain medication required after certain medical procedures. Ketamine is now being studied as a treatment for major depression, though it has not yet been approved by the FDA to treat depression.
“Finding out how we can best use Ketamine to improve treatment outcomes is our end goal. These trials and data are crucial as we move toward submitting an application to the FDA asking to have the drug reclassified for mental health. Being able to identify additional ways to monetize our brands starting with KetaDASH. We are exploring the benefits of ketamine treatment beyond addressing the known ailments of depression, anxiety and PTSD. We’re preparing to explore other neurological conditions, such as Parkinson’s disease and addiction, to name a few," added Benjamin Kaplan, Chief Executive Officer of Ehave.
About Ehave, Inc.
Ehave, Inc. (EHVVF) is a leader of digital therapeutics delivering evidence-based therapeutic interventions to patients. Our primary focus is on improving the standard care in therapeutics to prevent or treat brain disorders or diseases through the use of digital therapeutics, independently or together, with medications, devices, and other therapies to optimize patient care and health outcomes. Our main product is the Ehave Telemetry Portal, which is a mental health informatics platform that allows clinicians to make objective and intelligent decisions through data insights. The Ehave Infinity Portal offers a powerful machine learning and artificial intelligence platform with a growing set of advanced tools and applications developed by Ehave and its leading partners. This empowers patients, healthcare providers, and payers to address a wide range of conditions through high quality, safe, and effective data-driven involvement with intelligent and accessible tools. Additional information on Ehave can be found on the Company’s website at: www.ehave.com.
Forward-Looking Statement Disclaimer
Institutional Analyst is compensated for providing research coverage for Ehave Inc., please the report for disclosure and disclaimer details.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements: (i) the initiation, timing, progress and results of the Company’s research, manufacturing and other development efforts; (ii) the Company’s ability to advance its products to successfully complete development and commercialization; (iii) the manufacturing, development, commercialization, and market acceptance of the Company’s products; (iv) the lack of sufficient funding to finance the product development and business operations; (v) competitive companies and technologies within the Company’s industry and introduction of competing products; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) loss of key management personnel; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its products and its ability to operate its business without infringing the intellectual property rights of others; (ix) potential failure to comply with applicable health information privacy and security laws and other state and federal privacy and security laws; and (x) the difficulty of predicting actions of the USA FDA and its regulations. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement unless required by law. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is contained under the heading "Risk Factors" in Ehave, Inc.’s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) on September 24, 2015, as amended, which is available on the SEC's website, http://www.sec.gov.
Contact for Ehave
Media Inquiries: Gabe Rodriguez
Email: Gabe@Ehave.com
Investor Relations:
Email: Ir@Ehave.com
Phone: (623) 261-9046
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