clinical trial – MJ Shareholders https://mjshareholders.com The Ultimate Marijuana Business Directory Fri, 12 May 2023 15:49:10 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.4 Clearmind Medicine Announces IRB Approval to Conduct Clinical Trial on Alcohol Use Disorder https://mjshareholders.com/clearmind-medicine-announces-irb-approval-to-conduct-clinical-trial-on-alcohol-use-disorder/ Fri, 12 May 2023 15:49:10 +0000 https://cannabisfn.com/?p=2973092

Ryan Allway

May 12th, 2023

News, Top News, Top Story


News provided by Clearmind Medicine, May 12, 2023

IMCA medical center’s ethics committee approves clinical trial using proprietary CMND-100 treatment in Israel

Tel Aviv, Israel / Vancouver, Canada, May 12, 2023 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (Nasdaq, 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, has received Ethics Committee approval for itsCM-CMND-001 Phase I/II clinical trial of its MEAI-based CMND-100 compound for the treatment of alcohol use disorder (“AUD”) at Israel’s IMCA center.

CM-CMND-001 is a multinational, multi-center, single and multiple dose tolerability, safety and pharmacokinetic Study of CMND-100 in healthy volunteers and AUD subjects. The Israeli study will be led by Prof.Mark Weiser, M.D., head of the Psychiatric Division at the Sheba Medical Center in the Tel Aviv suburb of Ramat Gan. The company intends to have two additional sites in the United States, for this study, subject to signing an agreement with local sites.

The primary end point of the clinical trial is to find the tolerable dose and characterize the safety and pharmacokinetics/pharmacodynamics (PK/PD) of single and repeated doses of CMND-100 in healthy subjects and those with AUD. The secondary end point is to evaluate the efficacy of CMND-100 in reduction of drinking patterns and craving, in individuals with moderate-to-severe AUD. Oral capsules will be administered once daily, for ten consecutive days. The patients will report their drinking patterns and craving for alcohol (and cigarettes) during the clinical trial period.

“Ethics Committee approval of the study marks a key step forward in beginning the first-in-human clinical trial of CMND-100,” said Clearmind’s Chief Executive Officer, Dr. Adi Zuloff-Shani. “According to Research Nester, the alcohol treatment market is estimated to be USD 35 billion per year market in the U.S.alone, where the estimated number of people diagnosed with AUD total approximately 35 million people each year. Despite a significant addressable market and the fact AUD is a leading cause of death, current therapies often fall short due to limited efficacy, relapse rates, side effects and other factors. CMND-100 was shown to cause a significant and immediate reduction of alcohol cravings and consumption in pre-clinical studies with a high safety profile. As a result, we believe that CMND-001 holds tremendous potential as an alternative to current approaches. Moreover, CMND-100 is intended as a once-a-day oral capsule that can be taken from the privacy of one’s home. With CMND-100, we aim to revolutionize AUD treatment and improve patients’ compliance to therapy compared to other marketed pharmacotherapies”.

The Ethics Committee (which is the European and Israeli equivalent of the Institutional Review Board (IRB)), of the IMCA center, operating under the Declaration of Helsinki regulations and other international conventions concerning medical experiments on humans, is designated to authorize, review and monitor medical research and trials involving human subjects. The committee reviews research protocols and related materials (such as informed consent documents and investigator brochures) to ensure protection of the rights and welfare of the participants.

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:

Investor Relations
invest@clearmindmedicine.com
Telephone: (604) 260-1566

GeneralInquiries
Info@Clearmindmedicine.com
www.Clearmindmedicine.com

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. For example, theCompany is using forward-looking statements when it discusses the services to be performed by IMP and the benefit to the company therefrom, the timing of clinical trials, and the market size for AUD treatment and expected growth.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. 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 theSecurities 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.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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PharmAla Biotech to supply University of Sydney Clinical Trial with LaNeo™️ MDMA https://mjshareholders.com/pharmala-biotech-to-supply-university-of-sydney-clinical-trial-with-laneo%ef%b8%8f-mdma/ Wed, 31 Aug 2022 16:00:27 +0000 https://www.cannabisfn.com/?p=2960373

Disclaimer: Matters discussed on this website contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time-to-time have a position in the securities mentioned herein and will increase or decrease such positions without notice. The Information contains forward-looking statements, i.e. statements or discussions that constitute predictions, expectations, beliefs, plans, estimates, or projections as indicated by such words as “expects”, “will”, “anticipates”, and “estimates”; therefore, you should proceed with extreme caution in relying upon such statements and conduct a full investigation of the Information and the Profiled Issuer as well as any such forward-looking statements. Any forward looking statements we make in the Information are limited to the time period in which they are made, and we do not undertake to update forward looking statements that may change at any time; The Information is presented only as a brief “snapshot” of the Profiled Issuer and should only be used, at most, and if at all, as a starting point for you to conduct a thorough investigation of the Profiled Issuer and its securities and to consult your financial, legal or other adviser(s) and avail yourself of the filings and information that may be accessed at www.sec.gov, www.pinksheets.com, www.otcmarkets.com or other electronic sources, including: (a) reviewing SEC periodic reports (Forms 10-Q and 10-K), reports of material events (Form 8-K), insider reports (Forms 3, 4, 5 and Schedule 13D); (b) reviewing Information and Disclosure Statements and unaudited financial reports filed with the Pink Sheets or www.otcmarkets.com; (c) obtaining and reviewing publicly available information contained in commonlyknown search engines such as Google; and (d) consulting investment guides at www.sec.gov and www.finra.com. You should always be cognizant that the Profiled Issuers may not be current in their reporting obligations with the SEC and OTCMarkets and/or have negative signs at www.otcmarkets.com (See section below titled “Risks Related to the Profiled Issuers, which provides additional information pertaining thereto). For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity-based compensation in the companies it writes about, or a combination of the two. For full disclosure, please visit: https://www.cannabisfn.com/legal-disclaimer/. A short time after we acquire the securities of the foregoing company, we may publish the (favorable) information about the issuer referenced above advising others, including you, to purchase; and while doing so, we may sell the securities we acquired. In addition, a third-party shareholder compensating us may sell his or her shares of the issuer while we are publishing favorable information about the issuer. Except for the historical information presented herein, matters discussed in this article contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time to time have a position in the securities mentioned herein and will increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity- based compensation in the companies it writes about, or a combination of the two. For full disclosure please visit: https://www.cannabisfn.com/legal-disclaimer/.

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Entheon Biomedical Announces the Approval of DMT Clinical Trial https://mjshareholders.com/entheon-biomedical-announces-the-approval-of-dmt-clinical-trial/ Thu, 03 Feb 2022 18:19:36 +0000 https://www.cannabisfn.com/?p=2937143

Vancouver, British Columbia–(Newsfile Corp. – February 03, 2022) – Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon” or the “Company”), a biomedical company focused on the research and development of psychedelic drugs and leading-edge biomarkers to provide personalized treatment of addiction disorders, announced today the approval by the local Dutch ethics committee of EBRX-101, a comprehensive phase I clinical trial evaluating the pharmacokinetics, pharmacodynamics and safety profile of N,N-dimethyltryptamine (DMT). The study will be conducted at the Centre for Human Drug Research, in Leiden, Netherlands, with patient screening scheduled to begin this month.

The EBRX-101 study is the core research focus of Entheon Rx™, one of the Company’s business divisions, which is focused on advancing the therapeutic potential of DMT and DMT-based drug analogues. The study will use an adaptive, randomized, double-blind, placebo-controlled design with a single ascending dose of intravenous DMT to be administered via continuous-controlled infusion to a population of otherwise healthy smokers. This phase 1 study will provide Entheon with essential safety and dosing data, providing the foundation for further research of DMT’s therapeutic potential.

“DMT’s unique metabolic and neuroprotective properties, together with its record of safe human use in the scientific literature, suggests that it is an ideal candidate for therapeutic administration,” says Dr. Andrew Hegle, Chief Science Officer of Entheon. “However, it is crucial that we thoroughly investigate the pharmacological properties and safety profile of infused DMT in a clinical setting, and fully characterize its effects on the central nervous system. These results will form the basis for Entheon’s phase 2 efficacy trials for nicotine cessation and the treatment of other substance use disorders.”

DMT is a classic hallucinogen, similar to LSD or psilocybin in that it exerts many of its subjective, visual, and potentially therapeutic effects via the brain’s serotonin system. DMT differs from the other serotonergic psychedelics in that it is naturally found in the body in trace amounts, and when given externally is rapidly metabolized, with subjective effects returning to baseline after roughly thirty minutes post- administration.

“Approval of this study is a significant achievement for the company, marking the culmination of months of rigorous work,” says Timothy Ko, CEO of Entheon. “In our estimation and based on our review of existing literature, EBRX-101 is the most comprehensive studies of DMT to date. This clinical trial will serve as a benchmark for further investigation into the development of DMT as a treatment for addiction disorders.”

About Entheon Biomedical Corp.

Entheon is a biomedical company focused on the research and development of psychedelic drugs and leading-edge biomarkers to provide personalized treatment of addiction disorders. Entheon is comprised of three divisions, Entheon RX™, focused on the development of therapeutic drugs, using N, N-dimethyltryptamine (DMT) as the pharmacological benchmark; Entheon ID™, focused on identification, analysis and predictive use of EEG biomarkers and genetics in the selection and management of drug treatment; and Entheon IQ™, focused on the development of treatment algorithms through the analysis of patient data. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.

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Clinical Trial on Alzheimer’s Patients Indicates Positive Safety and Tolerability Data for IGC’s THC-Based Investigational New Drug https://mjshareholders.com/clinical-trial-on-alzheimers-patients-indicates-positive-safety-and-tolerability-data-for-igcs-thc-based-investigational-new-drug/ Tue, 14 Dec 2021 18:18:00 +0000 https://www.cannabisfn.com/?p=2936300

Ryan Allway

December 14th, 2021


POTOMAC, Md., December 14, 2021–(BUSINESS WIRE)–(NYSE American: IGC), India Globalization Capital, Inc. (“IGC” or the “Company”) today announced positive primary endpoint data for its Phase 1 clinical trial for IGC-AD1, which is a proprietary cannabinoid-based investigational new drug candidate for patients who have Alzheimer’s disease.

During the Phase 1 trial, minimal adverse events were reported, and IGC-AD1 was tolerated with no safety concerns identified by an independent Data Safety Monitoring Board. The Company has submitted the clinical trial data in its Clinical/Statistical Report (“CSR”) filed with the U.S. Food and Drug Administration (FDA) on December 1, 2021. In addition, as previously disclosed, data from the secondary and exploratory endpoints are also available on Form 8-K filed with the SEC on December 2, 2021.

In the short term, our strategy with IGC-AD1 is to demonstrate safety and tolerability, then, subject to FDA approval, to test and show efficacy in a large and diverse trial focused on symptoms associated with dementia in Alzheimer’s.

If our clinical trials satisfactorily demonstrate safety, tolerability, and efficacy, the Company’s goal is to apply to the FDA for approval of IGC-AD1 as a new drug.

The primary endpoint of our Phase 1 clinical trial was to test and demonstrate safety and tolerability. The trial was conducted as a multiple ascending dose (MAD) study. There were three Cohorts, with 12 patients in each cohort. Patients in Cohort 1, Cohort 2, and Cohort 3 received one, two, and three doses of IGC-AD1 per day, respectively, for 14 days.

The participants were a frail geriatric population with multiple comorbidities and mild to moderate Alzheimer’s disease. The average age was 80.9 years, and the average weight was 141.2 pounds. In addition, 66.7% of participants were women, and 33.3% were men. Safety and Tolerability (S&T) was assessed by asking participants to record Adverse Events (AEs). Participant recorded AEs included drowsiness (somnolence), falls, dizziness, weakness/lack of energy (asthenia), suicidal thoughts, hypertension, psychiatric symptoms, and paradoxical nausea. Each participant had a caregiver that assisted with the daily reporting. Using an FDA-defined protocol, the AEs were graded as mild, moderate, severe, life-threatening, and serious.

Across all three Cohorts, there were no serious or life-threatening AEs. There were no deaths, and no participant dropped out of the study due to the medication. Mild dizziness was reported by one patient in Cohort 1 that was deemed to be related to IGC-AD1. Apart from the mild dizziness, which self-resolved with no intervention, all other AEs across all three Cohorts were deemed unrelated to IGC-AD1 or the placebo.

The Company is encouraged by the data collected that indicates that even at the higher dosing levels tested in the Phase 1 trial, serious or life-threatening AEs did not result from the administration of ICG-AD1. Subject to FDA approval, the Company looks forward to continuing clinical trial testing of IGC-AD1 for safety, tolerability, and efficacy with the hope for a better life for people living with Alzheimer’s.

About IGC:

India Globalization Capital, Inc. (IGC), based in Maryland, engages in developing cannabinoid-based therapies for healthcare applications. The Company’s Life Science business recently completed a Phase 1 clinical trial on Alzheimer’s patients using a cannabinoid-based investigational new drug. The Company also operates an India-based infrastructure business. www.igcinc.uswww.igcpharma.com.

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based largely on IGC’s expectations and are subject to several risks and uncertainties, certain of which are beyond IGC’s control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company’s failure or inability to commercialize one or more of the Company’s products or technologies, including the investigational new drug or formulation described in this release, or failure to obtain FDA approval for the investigational new drug or additional clinical trials; testing results from human clinical trials that may not be favorable or as anticipated or consistent with the results obtained from Phase 1 trials; general economic conditions that are less favorable than expected, including as a result of the ongoing COVID-19 pandemic; the FDA’s general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC’s SEC filings. IGC incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Reports on Form 10-K filed with the SEC on June 14, 2021, and Quarterly Report on Form 10-Q, filed with the SEC on August 11, 2021, and October 29, 2021 as if fully incorporated and restated herein. In light of these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211214005476/en/

Contacts

Claudia Grimaldi
[email protected]
Phone: 301-983-0998

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Tryp Therapeutics Announces Phase 2a Clinical Trial for Fibromyalgia with the University of Michigan https://mjshareholders.com/tryp-therapeutics-announces-phase-2a-clinical-trial-for-fibromyalgia-with-the-university-of-michigan/ Wed, 21 Jul 2021 14:34:58 +0000 https://www.cannabisfn.com/?p=2926865

The study is expected to be the world’s first Phase 2a clinical trial evaluating the efficacy of psilocybin and psychotherapy to treat fibromyalgia

San Diego, California–(Newsfile Corp. – July 21, 2021) – Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) (“Tryp”), a pharmaceutical company focused on developing psilocybin-based compounds for diseases with unmet medical needs through accelerated regulatory pathways, announced today its plans to conduct a Phase 2a clinical trial with the Chronic Pain & Fatigue Research Center in the Department of Anesthesiology at the University of Michigan Medical School.

The open-label Phase 2a clinical trial will evaluate the efficacy of TRYP-8802, an oral formulation of synthetic psilocybin, in tandem with psychotherapy for treating fibromyalgia. The treatment is designed to target nociplastic pain originating in the central nervous system through the neuroplasticity benefits of psilocybin. The Principal Investigator for the trial will be Kevin Boehnke, Ph.D., Research Investigator, University of Michigan Department of Anesthesiology. Tryp will seek to identify a response in patients to the treatment to inform the design of a Phase 2b clinical trial for fibromyalgia that will use the company’s proprietary, psilocybin-based drug product, TRP-8803, that includes a novel formulation and unique method of delivery.

“Existing treatment options for fibromyalgia are often ineffective and show significant side effects,” said Daniel Clauw, M.D., Director of the Chronic Pain & Fatigue Research Center. “Kevin Boehnke and I are excited to be working with the team at Tryp Therapeutics, who have shown exceptional scientific rigor in their approach to evaluate a new treatment paradigm for the millions of patients suffering from fibromyalgia and other pain-related indications.”

Fibromyalgia is a disease of the central nervous system that is estimated to affect as much as 2% to 8% of the population. The disease is characterized by widespread pain commonly accompanied by fatigue, memory problems, and sleep disturbances. With available treatment options often proving ineffective, nearly 30% of fibromyalgia patients alarmingly resort to opioid-based medications in an attempt to address symptoms of pain stemming from the disease. Tryp expects to submit the Investigational New Drug (IND) application to the FDA for the Phase 2a clinical trial in 3Q 2021.

“We are thrilled to collaborate with such forward-looking clinicians and scientists to develop additional treatment options for fibromyalgia,” commented Jim Gilligan, Ph.D., President and Chief Science Officer at Tryp Therapeutics. “The Chronic Pain & Fatigue Research Center at the University of Michigan brings incomparable experience with evaluating treatments for fibromyalgia and other chronic pain indications, and there is nothing more important to our collective team than creating therapies that will address the daily distress of these patients.”

About Tryp Therapeutics:

Tryp Therapeutics is a pharmaceutical company focused on developing psilocybin-based compounds for the treatment of diseases with unmet medical needs through accelerated regulatory pathways. Tryp’s Psilocybin-For-Neuropsychiatric Disorders (PFN™) program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of chronic pain and eating disorder indications. The company has announced upcoming Phase 2a clinical trials with the University of Michigan and the University of Florida to evaluate its drug products for fibromyalgia and eating disorders, respectively. Tryp is also developing a proprietary psilocybin-based product, TRP-8803, that uses a novel formulation and method of delivery to improve the patient experience.

For more information, please contact us:

1-833-811-TRYP (8797)

[email protected]

www.tryptherapeutics.com

Forward-Looking Information

Certain information in this news release constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of Tryp’s final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/90865

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

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Tryp Therapeutics Partners with Fluence for Psychotherapy Design https://mjshareholders.com/tryp-therapeutics-partners-with-fluence-for-psychotherapy-design/ Mon, 03 May 2021 16:55:19 +0000 https://www.cannabisfn.com/?p=2919808

Ryan Allway

May 3rd, 2021

Psychedelics


San Diego, California–(Newsfile Corp. – May 3, 2021) – Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) (FSE: 8FW) (“Tryp”) a pharmaceutical company focused on developing clinical-stage compounds for diseases with unmet medical needs, announced today a master service agreement with Fluence to provide design and training for the psychotherapeutic portion of Tryp’s clinical trial activities.

Fluence is led by researchers and psychotherapists with direct experience in psychedelic clinical trials and is the foremost provider of psychotherapeutic training for health professionals that are administering psychedelic compounds to patients. The company is dedicated to increasing awareness, availability, and safety of psychedelic therapies, psychedelic integration, and related healthcare services.

“We are excited to partner with Tryp Therapeutics in support of the important research they are doing to develop treatment options for patients suffering from chronic pain, eating disorders, and other conditions,” said Ingmar Gorman, Ph.D., Co-Founder of Fluence. “Tryp has shown great commitment to promoting the safety and efficacy of psilocybin as a viable treatment option for clinicians.”

Tryp’s collaboration with Fluence will be initially focused on supporting Tryp’s upcoming Phase 2a clinical trial for eating disorders with Jennifer Miller, M.D., at the University of Florida. Fluence will consult on the design of psychotherapy protocols for the treatment and will provide extensive training for the therapists that will be conducting the trial.

“In the fast-moving arena of psychedelic therapies, Fluence has established themselves as the leader in psychotherapy design and training,” commented Jim Gilligan, Ph.D., President and Chief Science Officer of Tryp. “Psychotherapy is an essential component of the effective administration of our innovative psilocybin formulations for the chronic pain and eating disorder indications that we are pursuing. Fluence’s experience with training hundreds of clinicians combined with the training protocol they are creating with Tryp will help create a safer and more effective treatment protocol for our clinical trials and ultimately for patients suffering from these conditions.”

About Fluence

Fluence is an expertise-driven educational platform that provides professional training in psychedelic therapy and psychedelic integration for psychiatrists, psychotherapists, social workers, and other healthcare practitioners. Fluence’s mission is to give healthcare providers the clinical skills and knowledge to provide effective, compassionate, evidence-based psychedelic therapy and integration services to patients through dynamic, interactive online and in-person trainings.

www.fluencetraining.com

About Tryp Therapeutics

Tryp Therapeutics is a pharmaceutical company focused on developing clinical-stage compounds for the treatment diseases with unmet medical needs through accelerated regulatory pathways. Tryp’s Psilocybin-For-Neuropsychiatric Disorders, or PFN™, program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of certain neuropsychiatric-based disorders. Tryp’s lead PFN™ drug candidate is TRP-8802 for the treatment of fibromyalgia, a chronic pain syndrome estimated to affect more than 5 million people in the United States. The Company is also preparing to initiate a Phase 2a clinical study for eating disorders in partnership with Dr. Jennifer Miller at the University of Florida.

In addition to its PFN™ Program, Tryp is developing TRP-1001, an oral formulation of razoxane for the treatment of soft tissue sarcomas. Soft tissue sarcomas are a rare and diverse group of tumors that account for about 1% of all cancers in adults and 7% in children. Based on the prevalence of soft tissue sarcomas in the United States, Tryp believes that TRP-1001 should qualify for orphan status with the FDA.

For inquiries, please contact us at:

[email protected]
www.tryptherapeutics.com

Forward-Looking Information

Certain information in this news release, including statements relating to the anticipated closing date of the Placement, constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of Tryp’s final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

Ryan Allway

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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