NurExone Biologic Receives FDA Orphan-Drug Designation, Accelerating Development of ExoPTEN Therapy for Acute Spinal Cord Injury Treatment
NurExone Biologic Receives FDA Orphan-Drug Designation, Accelerating Development of ExoPTEN Therapy for Acute Spinal Cord Injury Treatment
TORONTO and HAIFA, Israel, Oct. 30, 2023 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V) (the "Company" or "NurExone"), a pioneering biotechnology company, is thrilled to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for its ExoPTEN therapy, recognizing the potential of this groundbreaking regenerative therapy for acute spinal cord injury, a condition where effective treatments are limitedi.
多倫多和以色列海法,2023年10月30日(Global Newswire)--領先的生物技術公司NurExone生物公司(多倫多證券交易所股票代碼:NRX)(FSE:J90)(NRX.V)(以下簡稱公司)欣喜若狂地宣佈,美國食品和藥物管理局(FDA)已批准其ExoPTEN療法獲得孤兒藥物稱號(ODD),認識到這種突破性的再生療法治療急性脊髓損傷的潛力,這種疾病的有效治療方法有限我。
The orphan drug designation provides significant benefits to pharmaceutical companies developing drugs for rare diseases, i.e. those impacting fewer than 200,000 people in the United Statesii. These benefits include market exclusivity, financial incentives, regulatory assistance, and support with drug development. Overall, the designation incentivizes and supports the development of certain treatments, increasing access to therapies for patients.
孤兒藥物的指定為製藥公司開發治療罕見疾病的藥物提供了重大好處,即那些在美國影響不到20萬人的藥物II。這些好處包括市場排他性、財政激勵、監管援助和對藥物開發的支持。總體而言,該指定激勵和支持某些治療的開發,增加患者獲得治療的機會。
Earning orphan-drug designation is a significant milestone for the Company. The designation covers the use of mesenchymal stem cell (MSC) derived small extracellular vesicles (EVs) loaded with short and modified interfering RNA (siRNA) targeting the phosphatase and tensin homolog (PTEN) protein for acute spinal cord injury, as implemented in the Company's ExoPTEN drug under development.
獲得孤兒藥物稱號對公司來說是一個重要的里程碑。該設計包括使用間充質幹細胞(MSC)來源的小細胞外小泡(EV),裝載針對磷酸酵素和緊張素同源蛋白(PTEN)蛋白的短和修改的幹擾RNA(SiRNA),用於治療急性脊髓損傷,如該公司正在開發的ExoPTEN藥物中實施的那樣。
"Orphan-drug designation is expected to streamline our go-to-market, shorten our regulatory process saving the Company millions of dollars, and provide valuable market exclusivity. We appreciate the formal recognition of the potential impact of our therapy on the lives of patients suffering from acute spinal cord injuries," said Dr. Shaltiel, CEO of NurExone Biologic, Ltd.
NurExone生物公司首席執行官沙爾蒂爾博士說:“孤兒藥物的指定有望簡化我們的上市流程,縮短我們的監管程式,為公司節省數百萬美元,並提供寶貴的市場獨佔性。我們感謝正式承認我們的治療方法對急性脊髓損傷患者的生活有潛在影響。”
About NurExone Biologic Inc.
關於NurExone生物公司
NurExone Biologic Inc. is a TSXV listed pharmaceutical company that is developing a platform for biologically-guided ExoTherapy to be delivered, non-invasively, to patients who suffered traumatic spinal cord injuries. ExoTherapy was conceptually demonstrated in animal studies at the Technion, Israel Institute of Technology. Via its fully-owned subsidiary, NurExone Biologic Ltd, NurExone is translating the treatment to humans, and the Company holds an exclusive worldwide license from the Technion and Tel Aviv University for the development and commercialization of the technology.
NurExone生物公司是一家在多倫多證券交易所上市的製藥公司,正在開發一個生物引導的體外治療平臺,以非侵入性的方式向遭受創傷性脊髓損傷的患者提供治療。體外療法在以色列理工學院的動物研究中得到了概念性的證明。通過其全資子公司NurExone生物有限公司,NurExone正在將這種治療轉化為人類,該公司擁有來自Technion和特拉維夫大學的獨家全球許可證,用於該技術的開發和商業化。
For additional information, please visit or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.
欲瞭解更多資訊,請訪問或跟隨NurExone OnLinkedIn,推特,Facebook,或YouTube。
For more information, please contact:
如需更多資訊,請聯繫:
Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com
Lior Shaltiel博士
董事首席執行官兼首席執行官
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:+1905-347-5569
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·羅伊特博士
投資關係-德國
電話:+49-69-1532-5857
電子郵件:e.reuter@dr-reur.eu
FORWARD-LOOKING STATEMENTS
前瞻性陳述
This press release contains certain "forward-looking statements", that reflect the Company's current expectations and projections about its future results. 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. Forward-looking statements in this press release include, but are not limited to, statements relating to the Company's ExoTherapy drug, ExoPTEN and the potential benefits to the Company of the orphan-drug designation of ExoPTEN. These statements reflect management's current beliefs and are based on information currently available to management as at the date hereof.
本新聞稿包含某些“前瞻性陳述”,這些陳述反映了公司目前對其未來業績的預期和預測。只要有可能,“可能”、“將”、“應該”、“可能”、“預期”、“計劃”、“打算”、“預期”、“相信”、“估計”、“預測”或“潛在”或這些詞語的否定或其他變體,或類似的詞語或短語,都被用來識別這些前瞻性表述。本新聞稿中的前瞻性陳述包括但不限於與該公司的外部治療藥物ExoPTEN有關的陳述以及指定孤兒藥物對公司的潛在好處ExoPTEN的基因。這些陳述反映了管理層目前的信念,並基於截至本文發佈之日管理層目前掌握的資訊。
In developing the forward-looking statements in this press release, we have applied several material assumptions, including our ability to retain key personnel, our ability to continue investing in research and development, our ability to secure available funding and to continue as a going concern, our ability to meet the post-approval requirements in respect of the orphan-drug designation, the general business and economic conditions of the industries and countries in which we operate, that the Company's operations in Israel will not be material disrupted by unrest in Israel and the Israel-Hamas War, our ability to execute on our business strategy, that there will be certain amount of demand for the Company's potential product, inflation will remain stable, and that the results of our studies reflect results that can be extrapolated.
在制定本新聞稿中的前瞻性陳述時,我們應用了幾個重要的假設,包括我們留住關鍵人員的能力,我們繼續投資研發的能力,我們獲得可用資金並繼續作為一家持續經營的公司的能力,我們滿足審批後要求的能力關於孤兒藥物的名稱,我們經營的行業和國家的一般商業和經濟狀況,公司在以色列的業務不會受到以色列動亂和以色列-哈馬斯戰爭的實質性幹擾,我們執行業務戰略的能力,對公司潛在產品的一定需求,通貨膨脹將保持穩定,我們的研究結果反映了可以推斷的結果。
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. These risks and uncertainties include, but are not limited to, risks related to the Company not being able to demonstrate clinical superiority of its ExoTherapy drug, ExoPTEN, 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, dependence on the Company's strategic partners, the effect of the Israel-Hamas War on the Company's operations and the risks discussed under the heading "Risk Factors" on pages 29 to 36 of the Company's Annual Information Form dated March 30, 2023, a copy of which is available under the Company's SEDAR+ profile at . 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.
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結果、業績或成就與前瞻性陳述中討論或暗示的結果大相徑庭。這些風險和不確定性包括,但不限於,與公司不是存在能夠展示ITS的臨床優勢體外治療藥物ExoPTEN,公司的早期發展階段,到目前為止的收入不足,政府監管,其產品的市場接受度,快速的技術變化,對關鍵人員的依賴,對公司知識產權的保護,對公司戰略的依賴以色列-哈馬斯戰爭對公司運營的影響,以及在公司日期為2023年3月30日的年度資訊表格第29至36頁“風險因素”標題下討論的風險,該表格的副本可在公司的SEDAR+簡介下查閱,網址:。這些因素應仔細考慮,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是基於管理層認為合理的假設,但公司不能向讀者保證實際結果將與這些前瞻性陳述一致。這些前瞻性陳述是截至本新聞稿發佈之日作出的,除非法律另有要求,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交易所及其監管服務提供商(該術語在多倫多證券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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