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Clearmind Medicine Forms a Data and Safety Monitoring Board to Oversee its First-in-Human Clinical Trial

Key Takeaway: Clearmind Medicine Inc. has established a Data and Safety Monitoring Board (DSMB) to oversee its first-in-human clinical trial focused on treating Alcohol Use Disorder. The DSMB comprises specialists in internal medicine, psychiatry, and biostatistics, tasked with ensuring participant safety and data integrity. The formation of this committee aligns with the company's commitment to prioritize patient safety during its clinical endeavors. Clearmind aims to develop psychedelic-derived therapeutics to address major health issues, emphasizing its novel approach in the pharmaceutical landscape.

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POSITIVE FACTORS

  • Formation of a Data and Safety Monitoring Board to enhance trial oversight.
  • Focus on patient safety throughout the clinical trials.
  • Commencement of first-in-human trials for Alcohol Use Disorder treatment.
  • Expert committee comprising specialists in relevant medical fields.

Full Press Release Details

Tel Aviv, Israel / Vancouver, Canada, April 27, 2023 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (NASDAQ: CMND) (CSE: CMND), (FSE: CWY) (“Clearmind” or “the company"), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced it has formed a Data and Safety Monitoring Board (DSMB) to oversee the company's first in human clinical trial, for Alcohol Use Disorder ("AUD") treatment.
The DSMB – an independent group of experts– includes a specialist in internal medicine, a specialist in psychiatry, and a biostatistician. The DSMB is a committee of experts responsible for reviewing clinical trial data on an ongoing basis to ensure the safety of study subjects and validity and integrity of the data.
“As we are approaching the beginning of our clinical trials in AUD, the formation of this committee is in line with the company's policy, which places patient safety at the center, throughout all stages of product development and use." said Dr. Adi Zuloff-Shani, Clearmind's Chief Executive Officer.
About Clearmind Medicine Inc.
Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.
The company’s intellectual portfolio currently consists of fourteen patent families. The company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.
Shares of Clearmind are listed for trading on Nasdaq and the Canadian Securities Exchange under the symbol "CMND" and the Frankfurt Stock Exchange under the symbol “CWY.”
For further information visit: https://www.clearmindmedicine.com or contact:
Telephone: (604) 260-1566
FORWARD-LOOKING STATEMENTS:
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. In addition, we cannot assure that any patent will issue as a result of a pending patent application or, if issued, whether it will issue in a form that will be advantageous to us. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F filed with the SEC on February 6, 2023. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

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Frequently Asked Questions

What is Clearmind Medicine focused on?

Clearmind Medicine specializes in developing psychedelic-derived therapeutics for under-treated health issues, particularly Alcohol Use Disorder.

What is the role of the Data and Safety Monitoring Board?

The DSMB oversees clinical trial safety, ensuring data integrity and participant protection throughout the study.

Who comprises the DSMB for Clearmind's trial?

The DSMB includes experts in internal medicine, psychiatry, and biostatistics.

How many patent families does Clearmind own?

Clearmind currently has fourteen patent families in its intellectual portfolio.

Where are Clearmind's shares listed?

Clearmind's shares are traded on Nasdaq, CSE, and Frankfurt Stock Exchange under CMND and CWY.

Last updated: Apr 27, 2023