Revive Therapeutics Provides Update on Cannabinoid Pharmaceuticals Program

Revive Therapeutics提供大麻素药物项目的最新信息

2021-02-12 01:02:31 CFN Media Group

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TORONTO, Feb. 11, 2021 (GLOBE NEWSWIRE) — Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide a corporate update on its cannabinoid pharmaceuticals program specifically as it relates to the clinical development of Cannabidiol (“CBD”) in the treatment of rare diseases and the Company’s novel drug delivery technology. Revive has built a portfolio of U.S. Food and Drug Administration (“FDA”) orphan drug designations for CBD that support the long-term potential of cannabinoid prescription medicines for rare diseases and disorders, which the Company believes has been validated by the FDA approval of the GW Pharmaceuticals plc EPIDIOLEX® product and the recently announced acquisition of GW Pharmaceuticals by Jazz Pharmaceuticals for $7.2 billion. For its rare disease cannabinoid product pipeline, Revive was granted in the past by the FDA two orphan drug designations for CBD in the treatment of autoimmune hepatitis, a rare liver disease, and CBD in the prevention of ischemia and reperfusion injury (“IRI”) resulting from solid organ transplantation, such as liver, kidney, heart and lung.  Revive recently entered into a clinical trial agreement with The Trustees of Indiana University (“TIU ”) to develop and manage a proposed Phase 2 clinical study entitled, “Use of Cannabidiol as an adjunct therapy for difficult to treat autoimmune hepatitis.” TIU and the Company are in the process of completing the protocol and study documents for submission of a pre-Investigational New Drug (“IND”) meeting with the FDA. Upon the receipt of permission from the FDA to proceed with the study under an IND, the Company will proceed to evaluate a potential study with CBD for ischemia/reperfusion injury and other liver diseases. There are over 100 described diseases of the liver affecting at least 30 million people alone in the U.S. A number of factors are driving the liver disease treatment market, which includes rapidly changing lifestyle patterns such as increasing alcohol consumption, unhealthy diets, and increasing prevalence of liver diseases. Liver diseases can result from injury to the liver caused by hepatitis C virus (HCV), hepatitis B virus (HBV), obesity, chronic excessive alcohol use or autoimmune diseases. Major drug categories used in the treatment of liver diseases includes anti-rejection drugs, vaccines, immunosuppressant, chemotherapy drugs and antiviral drugs. According to Allied Market Research, titled, “World Liver Disease Treatment Market – Opportunities and Forecast, 2014 – 2022”, the global market for liver disease treatment is projected to reach approximately $19.5 billion by 2022. As previously announced, the Company is developing its novel drug delivery technology for psychedelics and cannabinoids under a research agreement with the University of Wisconsin-Madison. This includes hydrogel formulations in combination with synthetic CBD which was evaluated in an anti-inflammatory preclinical model and successfully demonstrated a stable formulation with anti-inflammatory activity complementing the mode of action of CBD. The CBD hydrogel based on the delivery systems novel tannin-chitosan composite successfully demonstrated the control of synthetic CBD permeability through the simulated skin membrane, thus increasing the time for its availability and enabling the potential to be developed as a controlled or sustained release delivery system that may lead to single-dose treatments. The delivery technology shows potential to deliver both synthetic cannabinoids and natural extracts of cannabis in a potential number of ways such as topical gels, creams or ointments, oral or transdermal patches, and oral dosages. The delivery technology is a natural, non-toxic, biodegradable and biocompatible composite that combines a tannin material, which is derived from a plant group having antibacterial, antifungal, antioxidant and wound healing properties, and a chitosan material, which is derived from the crustacean group having blood-clotting and antimicrobial properties. The delivery technology has rapid onset of action and controlled or sustained release potential capabilities and may allow to combine multiple cannabinoids or cannabis extracts in one formulation, which unlocks the potential to develop novel products that target large dollar market opportunities such as pain (i.e. neuropathic, joint pain), inflammatory skin disorders (i.e. acne, psoriasis), wound healing applications (i.e. battle wounds, scarring) and liver diseases. “We have a unique portfolio of CBD-based pharmaceutical programs with validated research results which allowed for the FDA to grant us orphan drug designation in both autoimmune hepatitis and organ transplants as well as a novel drug delivery technology that has demonstrated the ability to formulate CBD in a hydrogel enabling the efficient and controlled delivery of CBD through the skin, thus unlocking significant market opportunities in inflammatory skin disorders and wound healing applications,” said Michael Frank, CEO of Revive. “Over the last year, we have evolved in focusing our clinical development programs in high demand pharmaceutical industries such as psychedelics, cannabinoids and infectious diseases that leverages our expertise in drug repurposing and drug delivery to enhance shareholder value.” About Revive Therapeutics Ltd. Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com. For more information, please contact: Michael Frank Chief Executive Officer Revive Therapeutics Ltd. Tel: 1 888 901 0036 Email: [email protected] Website: 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 “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 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 annual MD&A for the fiscal year ended June 30, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com. 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.
多伦多,2021年2月11日(环球新闻通讯社)--一家专注于研究和开发医疗需求和罕见疾病的疗法的专业生命科学公司--瑞维治疗有限公司(“瑞维”或“公司”)(CSE:RVV,USA:RVVTF)很高兴就其大麻素药物计划提供公司最新信息,特别是与大麻二醇(“CBD”)在罕见疾病治疗中的临床开发和公司的新型药物递送技术有关的信息。 Revive公司建立了一个美国食品和药物管理局(“FDA”)针对CBD的孤儿药指定组合,支持大麻素处方药治疗罕见疾病和失调的长期潜力,该公司认为,FDA批准了GW制药公司的Epidiolex®产品,以及Jazz制药公司最近宣布以72亿美元收购GW制药公司,都证实了这一点。 由于其罕见疾病大麻素产品管道,Revive过去曾被FDA授予两个孤儿药名称,用于治疗自身免疫性肝炎(一种罕见的肝病)的CBD,以及用于预防肝脏、肾脏、心脏和肺等实体器官移植引起的缺血和再灌注损伤(“IRI”)的CBD。Revive公司最近与印第安纳大学的受托人(“TIU”)达成了一项临床试验协议,以开发和管理一项名为“大麻二醇作为难治自身免疫性肝炎的辅助疗法的使用”的拟议的2期临床研究。TIU公司和该公司正在完成向FDA提交研究前新药(“IND”)会议的方案和研究文件。在获得FDA允许在IND下进行研究后,该公司将继续评估CBD对缺血/再灌注损伤和其他肝脏疾病的潜在研究。 仅在美国,就有超过100种已描述的肝脏疾病影响着至少3000万人。许多因素推动着肝病治疗市场的发展,其中包括快速变化的生活方式,如日益增加的饮酒量、不健康的饮食和日益增加的肝病患病率。丙型肝炎病毒(HCV)、乙型肝炎病毒(HBV)、肥胖、慢性过量饮酒或自身免疫性疾病对肝脏的损伤可导致肝脏疾病。用于肝病治疗的主要药物类别包括抗排斥药物、疫苗、免疫抑制剂、化疗药物和抗病毒药物。根据Allied Market Research题为“世界肝病治疗市场--2014-2022年的机会和预测”的报告,到2022年,全球肝病治疗市场预计将达到约195亿美元。 正如之前所宣布的,该公司正在根据与威斯康星大学麦迪逊分校的研究协议,开发其用于迷幻剂和大麻素的新型药物递送技术。这包括结合合成CBD的水凝胶制剂,该制剂在抗炎临床前模型中进行了评估,成功地证明了一种稳定的制剂具有抗炎活性,补充了CBD的作用模式。基于新型单宁-壳聚糖复合物的CBD水凝胶成功地控制了人工合成CBD通过模拟皮肤膜的通透性,从而延长了其可利用的时间,并使其成为一种可导致单剂量治疗的控制或缓释给药系统的潜力得以开发。这种递送技术显示有可能以各种可能的方式递送合成大麻素和大麻天然提取物,如局部凝胶、乳膏或软膏、口服或透皮贴剂以及口服剂量。 该递送技术是一种天然的、无毒的、可生物降解的和生物相容的复合物,其结合了来自具有抗菌、抗真菌、抗氧化和伤口愈合特性的植物组的单宁材料和来自具有凝血和抗菌特性的甲壳类动物组的壳聚糖材料。该递送技术具有快速起效和控制或持续释放的潜在能力,可以将多种大麻素或大麻提取物组合在一种制剂中,这释放了开发针对疼痛(即神经病、关节疼痛)、炎症性皮肤病(即痤疮、牛皮癣)、伤口愈合应用(即战伤、疤痕)和肝病等大美元市场机会的新型产品的潜力。 REVIVE公司首席执行官迈克尔·弗兰克说:“我们拥有独特的基于CBD的制药项目组合,其研究成果经验证,使FDA能够在自身免疫性肝炎和器官移植方面授予我们孤儿药的称号,同时我们还拥有一种新的药物递送技术,该技术证明了在水凝胶中配制CBD的能力,从而能够通过皮肤有效和可控地递送CBD,从而打开了炎症性皮肤病和伤口愈合应用方面的重大市场机会。”“在过去的一年里,我们在专注于高需求制药行业的临床开发项目方面取得了进展,这些行业包括迷幻药、大麻素和传染病,利用我们在药物再用途和药物提供方面的专业知识来提高股东价值。” 关于Revive Therapeutics Ltd. Revive是一家生命科学公司,专注于传染病和罕见疾病治疗药物的研究和开发,它正在优先考虑药物开发工作,以利用FDA授予的几项监管激励措施,如孤儿药、快速通道、突破性疗法和罕见儿科疾病指定。目前,该公司正在探索将布西拉明用于潜在的传染病治疗,最初的重点是重症流感和新冠肺炎。Revive公司最近收购了Psilocin Pharma Corp.公司,正在推动以Psilocybin为基础的治疗各种疾病和失调的药物的发展。REVIVE的大麻素药物组合专注于罕见的炎症疾病,该公司因使用大麻二醇(CBD)治疗自身免疫性肝炎(肝病)和治疗器官移植引起的缺血和再灌注损伤而被FDA授予孤儿药地位。欲了解更多信息,请访问www.revivethera.com。 欲了解更多信息,请联系: 迈克尔·弗兰克 首席执行官 瑞维治疗有限公司。 电话:1 888 901 003 6 电子邮件:[电子邮件受保护] 网址:www.revivethera.com 加拿大证券交易所及其监管服务提供商均未对本版本的充分性或准确性进行审查或承担责任。 告诫性声明 本新闻稿包含适用的加拿大证券立法含义范围内的“前瞻性信息”。这些陈述与未来事件或未来业绩有关。使用“可能”、“打算”、“预期”、“相信”、“将”、“预计”、“估计”等词语以及与非历史事实相关的类似表述和陈述,旨在确定前瞻性信息,并基于REVIVE公司目前对此类未来事件的结果和时间的信念或假设。本新闻稿中的前瞻性信息包括与该公司大麻素、迷幻剂和传染病项目有关的信息。前瞻性信息是基于Revive公司在该信息发布之日所作的合理假设,并受已知和未知风险、不确定性和其他因素的影响,这些因素可能导致实际结果或事件与前瞻性信息中预期的结果或事件有重大差异。鉴于这些风险、不确定性和假设,您不应过度依赖这些前瞻性陈述。本新闻稿中包含的前瞻性信息是在本新闻稿发布之日起提供的,瑞维公司没有义务更新或修订任何前瞻性信息,无论是由于新信息、未来事件或其他原因,但适用证券法要求的除外。上述声明明确限定了本文中包含的任何前瞻性信息。兹参考本公司截至2020年6月30日财政年度的年度MD&A中“风险因素”项下披露的风险因素,该年度MD&A已在SEDAR上备案,并可在本公司简介www.SEDAR.com下查阅。 本文由CFN Enterprises Inc.(OTCQB:CNFN)发表,该公司是CFN Media的所有者和运营商,CFN Media是该行业的领先机构,也是致力于新兴的CBD和合法大麻行业的数字金融媒体网络。欲了解更多信息,请致电+1(833)420-CNFN。

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