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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在全球峯會上介紹外泌體療法的新監管途徑
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."

多倫多和以色列海法,2024年3月1日(GLOBE NEWSWIRE)——開創性生物製藥公司NurexOne Biologic Inc.(TSXV:NRX)(德國:J90)(“公司” 或 “NurexOne”)很高興地宣佈,NurexOne的CMC、質量和監管事務主管伊娜·薩雷爾博士將在即將到來的Exosome上主持研討會表徵與分析開發峯會。薩雷爾博士將與她的專家同事分享有關 “基於細胞外囊泡(EV)的臨床產品開發中的監管挑戰” 這一主題的見解和信息。

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.

薩雷爾博士加入了享有盛譽的演講者陣容,其中包括來自領先的外泌體公司的代表,例如艾伯維、RION Therapeutics、Aegle Therapeutics和大學,例如哈佛醫學院。憑藉她在監管事務方面的經驗和對外泌體領域的深刻理解,薩雷爾博士完全有能力就如何駕馭複雜的監管環境和確保基於外泌體的療法的成功開發提供觀點。

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."

薩雷爾博士領導了導致該公司正在開發的外泌體療法exOpten獲得孤兒藥認定資格的活動。他說:“NurexOne正在開發一個平台,使用外泌體制造各種納米藥物,包括我們的第一種用於治療急性脊髓損傷患者的藥物ExOpten。我們很自豪能夠分享我們的開發成果和我們的監管專業知識,並致力於推進臨床外泌體療法領域的發展。”

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.

外泌體表徵與分析開發峯會是一項重要的活動,彙集了來自學術界和業界的專家,討論外泌體表徵和分析開發的最新進展。峯會將於2024年4月23日至25日在馬薩諸塞州波士頓舉行。要了解有關峯會的更多信息並進行註冊,請訪問會議網站。

About NurExone Biologic Inc.

關於 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. 是一家在多倫多證券交易所上市的製藥公司,正在開發一個平台,用於以非侵入性方式向中樞神經系統損傷的患者提供基於生物制導的外泌體療法。事實證明,該公司的第一款治療急性脊髓損傷的產品exOpten在鼻內給藥後可恢復75%的實驗室大鼠的運動功能。Exopten已被美國食品藥品管理局授予孤兒藥稱號。NurexOne平台技術有望爲其他適應症的非侵入性靶向藥物遞送感興趣的製藥公司提供新的解決方案。

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

欲了解更多信息,請訪問 或者關注 NurexOne 領英,推特, Facebook,或 優酷

For more information, please contact:

欲了解更多信息,請聯繫:

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

Lior Shaltiel 博士
首席執行官兼董事
電話:+972-52-4803034
電子郵件:info@nurexone.com

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

論文資本公司
投資關係-加拿大
電話:+1 905-347-5569
電子郵件: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
投資關係-德國
電話:+49-69-1532-5857
電子郵件:e.reuter@dr-reuter.eu

FORWARD-LOOKING STATEMENTS

前瞻性陳述

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.

本新聞稿包含某些前瞻性陳述,包括有關公司未來計劃和知識產權、公司將開展的科學與開發和商業活動、外泌體的有效裝載、未來潛在的製造、臨床、許可和營銷活動以及某些疾病治療的陳述。儘可能使用諸如 “可能”、“將”、“應該”、“可以”、“期望”、“計劃”、“打算”、“預測”、“相信”、“估計” 或 “潛在” 等詞語或這些詞語的負面或其他變體,或類似的詞語或短語來識別這些前瞻性陳述。這些陳述反映了管理層當前的信念,並基於截至本文發佈之日管理層目前獲得的信息。前瞻性陳述涉及重大風險、不確定性和假設。許多因素可能導致實際業績、業績或成就與前瞻性陳述中討論或暗示的結果存在重大差異。某些假設包括公司有能力在內部和通過許可將其知識產權商業化,以及公司擁有適當的團隊來實現商業化。風險和不確定性包括但不限於與公司早期發展階段相關的風險、迄今爲止收入不足、政府監管、其產品的市場接受度、快速的技術變革、對關鍵人員的依賴、公司知識產權的保護以及對公司戰略合作伙伴的依賴。應仔細考慮這些因素,讀者不應過分依賴前瞻性陳述。儘管本新聞稿中包含的前瞻性陳述基於管理層認爲的合理假設,但公司無法向讀者保證實際業績將與這些前瞻性陳述一致。這些前瞻性陳述自本新聞稿發佈之日起作出,除非法律要求,否則公司沒有義務更新或修改這些陳述以反映新的事件或情況。

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.

多倫多證券交易所風險投資交易所及其監管服務提供商(該術語在多倫多證券交易所風險交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。


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