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NurExone Presenting Novel Regulatory Pathways for Exosomes Therapies at Global Summit

NurExone Presenting Novel Regulatory Pathways for Exosomes Therapies at Global Summit

NurexOne在全球峰会上介绍外泌体疗法的新监管途径
GlobeNewswire ·  03/01 16:04

TORONTO and HAIFA, Israel, March 01, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (Germany: J90) (the "Company" or "NurExone"), a pioneering biopharmaceutical company, is pleased to announce that Dr. Ina Sarel, the Head of CMC, Quality and Regulatory Affairs at NurExone, will be leading a workshop at the upcoming Exosome Characterization & Analytical Development Summit. Dr. Sarel will be sharing with her expert colleagues insight and information on the topic of "Regulatory Challenges in the Development of an Extracellular Vesicles (EVs) - Based Clinical Product."

多伦多和以色列海法,2024年3月1日(GLOBE NEWSWIRE)——开创性生物制药公司NurexOne Biologic Inc.(TSXV:NRX)(德国:J90)(“公司” 或 “NurexOne”)很高兴地宣布,NurexOne的CMC、质量和监管事务主管伊娜·萨雷尔博士将在即将到来的Exosome上主持研讨会表征与分析开发峰会。萨雷尔博士将与她的专家同事分享有关 “基于细胞外囊泡(EV)的临床产品开发中的监管挑战” 这一主题的见解和信息。

Dr. Sarel joins a prestigious lineup of speakers including representatives from leading exosome companies, e.g. AbbVie, RION Therapeutics, Aegle Therapeutics and universities, e.g. Harvard Medical school. With her experience in regulatory affairs and her deep understanding of the exosome field, Dr. Sarel is well-positioned to provide perspective on how to navigate the complex regulatory landscape and ensure the successful development of exosome-based therapeutics.

萨雷尔博士加入了享有盛誉的演讲者阵容,其中包括来自领先的外泌体公司的代表,例如艾伯维、RION Therapeutics、Aegle Therapeutics和大学,例如哈佛医学院。凭借她在监管事务方面的经验和对外泌体领域的深刻理解,萨雷尔博士完全有能力就如何驾驭复杂的监管环境和确保基于外泌体的疗法的成功开发提供观点。

Dr. Sarel who led the activities that resulted in the grant of Orphan Drug Designation for ExoPTEN, an exosome-therapy being developed by the Company, stated "NurExone is developing a platform for using exosomes to create wide range of nanodrugs including our first drug - ExoPTEN, for treating patients with acute spinal cord injury. We are proud to share our development outcomes together with our regulatory expertise and are committed to advancing the field of exosome therapeutics for clinical use."

萨雷尔博士领导了导致该公司正在开发的外泌体疗法exOpten获得孤儿药认定资格的活动。他说:“NurexOne正在开发一个平台,使用外泌体制造各种纳米药物,包括我们的第一种用于治疗急性脊髓损伤患者的药物ExOpten。我们很自豪能够分享我们的开发成果和我们的监管专业知识,并致力于推进临床外泌体疗法领域的发展。”

The Exosome Characterization & Analytical Development Summit is a premier event that brings together experts from academia and industry to discuss the latest advancements in exosome characterization and analytical development. The summit will take place on April 23-25, 2024 in Boston, MA. To learn more about the summit and to register, please visit the Conference Website.

外泌体表征与分析开发峰会是一项重要的活动,汇集了来自学术界和业界的专家,讨论外泌体表征和分析开发的最新进展。峰会将于2024年4月23日至25日在马萨诸塞州波士顿举行。要了解有关峰会的更多信息并进行注册,请访问会议网站。

About NurExone Biologic Inc.

关于 Nurexone Biologic Inc.

NurExone Biologic Inc. is a TSXV listed pharmaceutical company that is developing a platform for biologically-guided exosome-based therapies to be delivered, non-invasively, to patients who have suffered Central Nervous System injuries. The company's first product, ExoPTEN for acute spinal cord injury, was proven to recover motor function in 75% of laboratory rats when administered intranasally. ExoPTEN has been granted Orphan Drug Designation bythe FDA. The NurExone platform technology is expected to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.

NurexOne Biologic Inc. 是一家在多伦多证券交易所上市的制药公司,正在开发一个平台,用于以非侵入性方式向中枢神经系统损伤的患者提供基于生物制导的外泌体疗法。事实证明,该公司的第一款治疗急性脊髓损伤的产品exOpten在鼻内给药后可恢复75%的实验室大鼠的运动功能。Exopten已被美国食品药品管理局授予孤儿药称号。NurexOne平台技术有望为其他适应症的非侵入性靶向药物递送感兴趣的制药公司提供新的解决方案。

For additional information, please visit or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.

欲了解更多信息,请访问 或者关注 NurexOne 领英,推特, Facebook,或 优酷

For more information, please contact:

欲了解更多信息,请联系:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com

Lior Shaltiel 博士
首席执行官兼董事
电话:+972-52-4803034
电子邮件:info@nurexone.com

Thesis Capital Inc.
Investment Relation - Canada
Phone: +1 905-347-5569
Email: IR@nurexone.com

论文资本公司
投资关系-加拿大
电话:+1 905-347-5569
电子邮件:IR@nurexone.com

Dr. Eva Reuter
Investment Relation - Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu

伊娃·路透博士
投资关系-德国
电话:+49-69-1532-5857
电子邮件:e.reuter@dr-reuter.eu

FORWARD-LOOKING STATEMENTS

前瞻性陈述

This press release contains certain forward-looking statements, including statements about the Company's future plans and intellectual property, the scientific and development and commercial activities to be carried out by the company, the efficient loading of exosomes, future potential manufacturing, clinical, licensing and marketing activities and the treatment of certain conditions. Wherever possible, words such as "may", "will", "should", "could", "expect", "plan", "intend", "anticipate", "believe", "estimate", "predict" or "potential" or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. These statements reflect management's current beliefs and are based on information currently available to management as at the date hereof. Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. Certain assumptions include the ability of the Company to commercialize its intellectual property internally and through licensing and that the Company has the appropriate team in order to realize commercialization. Risks and uncertainties include, but are not limited to, risks related to the Company's early stage of development, lack of revenues to date, government regulation, market acceptance for its products, rapid technological change, dependence on key personnel, protection of the Company's intellectual property and dependence on the Company's strategic partners. These factors should be considered carefully and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.

本新闻稿包含某些前瞻性陈述,包括有关公司未来计划和知识产权、公司将开展的科学与开发和商业活动、外泌体的有效装载、未来潜在的制造、临床、许可和营销活动以及某些疾病治疗的陈述。尽可能使用诸如 “可能”、“将”、“应该”、“可以”、“期望”、“计划”、“打算”、“预测”、“相信”、“估计” 或 “潜在” 等词语或这些词语的负面或其他变体,或类似的词语或短语来识别这些前瞻性陈述。这些陈述反映了管理层当前的信念,并基于截至本文发布之日管理层目前获得的信息。前瞻性陈述涉及重大风险、不确定性和假设。许多因素可能导致实际业绩、业绩或成就与前瞻性陈述中讨论或暗示的结果存在重大差异。某些假设包括公司有能力在内部和通过许可将其知识产权商业化,以及公司拥有适当的团队来实现商业化。风险和不确定性包括但不限于与公司早期发展阶段相关的风险、迄今为止收入不足、政府监管、其产品的市场接受度、快速的技术变革、对关键人员的依赖、公司知识产权的保护以及对公司战略合作伙伴的依赖。应仔细考虑这些因素,读者不应过分依赖前瞻性陈述。尽管本新闻稿中包含的前瞻性陈述基于管理层认为的合理假设,但公司无法向读者保证实际业绩将与这些前瞻性陈述一致。这些前瞻性陈述自本新闻稿发布之日起作出,除非法律要求,否则公司没有义务更新或修改这些陈述以反映新的事件或情况。

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

多伦多证券交易所风险投资交易所及其监管服务提供商(该术语在多伦多证券交易所风险交易所的政策中定义)均不对本新闻稿的充分性或准确性承担责任。


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