Cannabinoids

TORONTO, Sept. 18, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for infectious diseases and medical countermeasures, announced today its strategic focus on dedicating its resources to advancing the clinical development of Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties. The Company has decided not to pursue the development of the Long COVID diagnostic product. The Company will be focusing on the following programs with Bucillamine for infectious diseases and medical countermeasures: Nerve Agent Exposure Nerve agents are chemicals that affect the nervous system. Nerve agents are highly toxic regardless of the route of exposure. The main chemical nerve agents that are man-made and manufactured for use in chemical warfare are sarin, soman, tabun and VX. These nerve agents are known to be present in military stockpiles. Exposure to nerve agents can occur due to chemical warfare or accidental release from a military storage facility. Exposure to nerve agents can cause tightness of the chest, excessive salivation, abdominal cramps, diarrhea, blurred vision, tremors, and death. Currently, in partnership with Defence R&D Canada – Suffield Research Centre (“DRDC”), an agency of the Canadian Department of National Defence, the Company is evaluating Bucillamine as a potential treatment for nerve agent exposure. DRDC is investigating pharmacological compounds that can mitigate nerve agent induced brain injury. Recent studies have shown that antioxidant compounds such as n-acetylcysteine (“NAC”) could be beneficial in limiting seizure activity and improving the anticonvulsant efficacy of GABA-mediating drugs such as diazepam. Bucillamine is a significantly more effective antioxidant than NAC and has the potential to provide increased efficacy against seizure activity while limiting the anticoagulant and bleeding event liability observed with NAC. The overall objective of the research project is to investigate pharmacological means for neuroprotection of GABA(A) receptors, which are required for the effectiveness of currently fielded anticonvulsant therapies. Bucillamine and NAC will be evaluated to determine the effect on GABA(A) receptor endocytosis and the effect on diazepam effectiveness in terminating seizures. Any additional antioxidant effects on seizure activity and survival will also be assessed. The results from this research partnership, if promising, will determine further studies to facilitate FDA and Health Canada approvals for the use of Bucillamine in nerve agents or organophosphate pesticide poisoning. Also, the Company may explore the potential of Bucillamine for traumatic brain injury caused by concussive or explosive forces. The research study is progressing and is expected to be now completed in October 2024. Emerging Infections The results from the DRDC research study, if promising, may determine further studies for the potential use of Bucillamine in various viral infections, including monkeypox (“Mpox”). In 2023, the World Health Organization released a Mpox fact sheet suggesting that severe cases of Mpox result in a number of conditions, including inflammation of the brain, heart, rectum, genital organs and urinary passages.1 A study in 2022 made the link between the administration of antioxidants and the improvement of virus-induced effects or to reduce viral replication yield. The suggestion that strong antioxidants such as N-acetyl-L-cysteine (“NAC”), butylated hydroxyanisole or Terameprocol could have an effect on Mpox viral infection in humans to ease severe symptoms.2 NAC has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione.3-6 Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC.7 Long COVID The CDC estimates that 7.5 percent of U.S. adults have long COVID symptoms.8 David Cutler, PhD, a professor of economics at Harvard University, estimates in a recent research disclosure that the total economic cost of long COVID could be as much as $3.7 trillion.9 Currently, the Company is exploring the use of Bucillamine as a potential treatment for long COVID by leveraging the published research and data from its previous Phase 3 clinical trial. Per the results of the Type C meeting written responses received by the Company from the U.S. Food & Drug Administration (“FDA”) for the evaluation of a proposed clinical study of Bucillamine as a potential treatment for Long COVID, the FDA has recommended that the evaluation of Bucillamine for Long COVID be submitted as a new Investigational New Drug (“IND”) application and may cross-reference applicable sections from the Company’s current IND, that evaluated the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19 in the Phase 3 clinical trial. In addition, the FDA provided valuable feedback on the appropriate design, study population, and safety and efficacy measures for assessing a therapeutic benefit in patients with Long COVID. The Company is finalizing the proposed Phase 2 study protocol for submission to the FDA. It expects to submit it by the end of 2024. The proposed Phase 2 clinical study is expected to be approved by the FDA in Q1-2025. As a background, on July 6, 2023, the Company announced the results of its Study evaluating the safety and efficacy of oral Bucillamine in patients with mild to moderate COVID-19. Under the Study’s primary endpoint, the proportion of patients meeting a composite endpoint of hospitalization or death from time of first dose through Day 28 following randomization, there were no deaths and four hospitalizations, of which three were from the placebo arm and one from the Bucillamine low dose group (300mg/day). No hospitalizations occurred in the Bucillamine large dose group (600mg/day). The Company evaluated certain Study endpoints, including the COVID-19 clinical symptoms data (i.e. cough, fever, heart rate, and oxygen saturation). Based on preliminary analyses, the data demonstrated that for patients with oxygen saturation <96% at baseline, Bucillamine had a 29.1% improvement over placebo in time to normal oxygen saturation (SpO2). Additional analyses of the Study data may suggest Bucillamine’s potential for long COVID. A study titled, “Thiol-based drugs decrease binding of SARS-CoV-2 spike protein to its receptor and inhibit SARS-CoV-2 cell entry”, showed that thiol-based drugs, like Bucillamine, decrease the binding of SARS-CoV-2 spike protein to its receptor, decrease the entry efficiency of SARS-CoV-2 spike pseudotyped virus, and inhibit SARS-CoV-2 live virus infection. These findings uncovered a vulnerability of SARS-CoV-2 to thiol-based drugs and provided a rationale to test thiol-based drugs such as Bucillamine as novel treatments for COVID-19. The Company would like to make it clear that it is not making any express or implied claims that its product (Bucillamine) has the ability to treat, eliminate or cure long COVID, Monkeypox (Mpox) and/or other infectious diseases and medical countermeasures indications at this time. About Revive Therapeutics Ltd. Revive Therapeutics is a life sciences company focused on the research and development of therapeutics for infectious diseases and medical countermeasures. Revive prioritizes its drug development efforts to take advantage of several regulatory incentives awarded by the FDA, such as Emergency Use Authorization, Orphan Drug, Fast Track, and Breakthrough Therapy designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of nerve agent exposure and long COVID. Revive is also advancing the development of Psilocybin-based therapeutics through various programs. For more information, visit www.ReviveThera.com. For more information, please contact: Michael FrankChief Executive OfficerRevive Therapeutics Ltd.Tel: 1 888 901 0036Email: mfrank@revivethera.comWebsite: www.revivethera.com Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release. Cautionary Statement This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “may”, “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company's management's discussion and analysis for the three and nine months ended March 31, 2024 ("MD&A"), dated May 28, 2024, which is available on the Company's profile at www.sedarplus.ca. References: https://www-who-int.libproxy1.nus.edu.sg/news-room/fact-sheets/detail/monkeypoxAydemir D, Ulusu NN. The possible importance of the antioxidants and oxidative stress metabolism in the emerging monkeypox disease: An opinion paper. Front Public Health. 2022 Oct 20;10:1001666.L. Carati et al, Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment., Eur Respir J. 1997 Jul;10(7):1535-41).M Mata et al, N-acetyl-L-cysteine (NAC) inhibit mucin synthesis and pro-inflammatory mediators in alveolar type II epithelial cells infected with influenza virus A and B and with respiratory syncytial virus (RSV)., Biochem Pharmacol. 2011 Sep;82(5):548-55.D Ungheri et al, Protective effect of n-acetylcysteine in a model of influenza infection in mice., Int J Immunopathol Pharmacol. 2000 Sep-Dec;13(3):123-128.RH Zhang et al, N-acetyl-l-cystine (NAC) protects against H9N2 swine influenza virus-induced acute lung injury., Int Immunopharmacol. 2014 Sep;22(1):1-8).LD Horwitz, Bucillamine: a potent thiol donor with multiple clinical applications, Cardiovasc Drug Rev. 2003 Summer;21(2):77-90).“Nearly One in Five American Adults Who Have Had COVID-19 Still Have “Long COVID,” CDC, June 6, 2022, https://www-cdc-gov.libproxy1.nus.edu.sg/nchs/pressroom/nchs_press_releases/2022/20220622.htm“The Economic Cost of Long COVID: An Update,” David M. Cutler, Harvard University, July 22, 2022, https://scholar.harvard.edu/files/cutler/files/long_covid_update_7-22.pdf

Manufacturer of Idrasil™, the first standardized medical cannabis, launches after 14 years of research and development, takes aim at U.S. pharmaceutical industry and its opioid epidemic. ANAHEIM, Calif., Sept. 17, 2024 /PRNewswire/ -- C3 Pharmaceuticals, Inc., a private biopharmaceutical company formed to leverage first-mover advantage and play a leadership role in the emerging pharmaceutical cannabinoid therapeutics health sector, is pleased to announce that it executed a tailored Share Subscription Agreement (SSA) with GEM Global Yield LLC SCS ("GGY") and is planning on listing on the Canadian Securities Exchange. The listing will offer investors the solution to the cannabis prescribing problem in America, which originated from a misunderstood prohibition in the 1940s. Idrasil, the primary intellectual property held by C3 Pharmaceuticals, Inc., is a dry, anhydrous, scored tablet containing a standardized and consistent amount of naturally derived, concentrated cannabis extract. This blend is designed to help patients manage a variety of conditions while remaining sober and lucid. These conditions include chronic pain, ADD, Alzheimer's, cancer, sleep disorders, mental health issues, and withdrawal from opioid addiction. Idrasil will be manufactured in a pharmaceutical-grade facility with a process that is G.R.A.S, FDA-compliant, sterile, and manufactured under cGMP and ISO 9001 standards. "I started helping patients in 2005 by providing safe access to cannabis and offering the prescribing community an alternative to deadly opioids. Fourteen years later, I am saddened to say that the global opioid crisis has only become worse, claiming an estimated 69,000 lives each year," says Steele Clarke Smith III, Chairman and CEO of C3 Pharmaceuticals, Inc. "Now we're finally on the verge of curbing the problem and providing people with a prescribable, non-addictive solution to their physical and mental ailments." "Idrasil is expected to be a highly disruptive medical advancement in recent pharmaceutical history," Steele says. This is why there have been legal and bureaucratic obstacles to bringing it to market and securing insurance approvals. However, U.S. lawmakers are close to passing legislation that would allow veterans to be treated with much-needed prescription cannabis-based medications – a milestone that Steele believes is long past due, for Quality of Life (QoL). "We are currently at a crucial point in the United States, both politically and culturally, regarding the growing acceptance of natural medicines, particularly therapeutic cannabinoids," Steele explains. "There are numerous clinical EndoCannabinoid Deficiencies that are among people of all ages in a population deficient in cannabinoids, which can easily be corrected by reintroducing cannabinoids to the human body." Idrasil achieves this through prescriptions provided by doctors. The capital raised from the IPO, along with a commitment of CAD$135 million (approximately USD$100 million) from GGY, will be used to expand manufacturing operations and introduce Idrasil to the U.S. and then international markets. Additionally, it will strengthen the company's intellectual property portfolio in the pharmaceutical sector as a leader in nutraceuticals. "Now is the perfect time to open C3 Pharmaceuticals, Inc. to the public capital markets and bring the global investment community into a prosperous new age where natural medicines are embraced and petrochemical-based drugs are recognized for what they truly are: poisons," Steele said. For more information, visit . About Idrasil and C3 Pharmaceuticals, Inc. The mission of C3 Pharmaceuticals, Inc. is to manufacture the unique Intellectual Property for Idrasil, a major advancement in the standardization and administering of natural cannabinoids, in a tablet. Idrasil is a holistic alternative to addictive opiates and life-threatening narcotics, without euphoria. For more information on C3 Pharmaceuticals, Inc. and Idrasil, visit . About GEM Global Emerging Markets ("GEM") is a $3.4 billion, alternative investment group with offices in Paris, New York and Nassau, Bahamas. GEM manages a diverse set of investment vehicles focused on emerging markets and has completed over 580 transactions in 70 countries. Each investment vehicle has a different degree of operational control, risk-adjusted return, and liquidity profile. The family of funds and investment vehicles provide GEM and its partners with exposure to: Small-Mid Cap Management Buyouts, Private Investments in Public Equities, and select venture investments. For more information: . CONTACT: Andrew King, [email protected] SOURCE C3 International Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED