share_log

On Path to First-in-Human Study, NurExone Engages Prominent Expert in Biological Drug Development

On Path to First-in-Human Study, NurExone Engages Prominent Expert in Biological Drug Development

在進行首例人體研究時,NurExone聘請了傑出的生物藥物開發專家
GlobeNewswire ·  06/22 04:04

TORONTO and HAIFA, Israel, June 21, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX), (OTCQB: NRXBF), (Germany: J90) (the "Company" or "NurExone"), a pioneering biopharmaceutical company, welcomes Dr. Yona Geffen, as a consultant, to support the Company's preclinical and clinical activities. Dr. Geffen, who currently serves as Vice President of Research and Development at Gamida Cell Ltd. ("Gamida Cell"), brings over two decades of extensive experience in leading clinical and drug development in the biotechnology and pharmaceutical industries. Under her leadership, Gamida Cell obtained United States Food and Drug Administration approval for Omisirge, a groundbreaking stem cell therapy.

NurExone生物製品公司(TSXV:NRX,OTCQB: NRXBF,Germany:J90)是一家開創性的生物製藥公司,歡迎Dr. Yona Geffen加入公司作爲顧問,支持NurExone的臨床前和臨床活動。Dr. Geffen目前擔任Gamida Cell Ltd.的研發副總裁,擁有在生物技術和藥品行業領導臨床和藥物開發方面超過20年的豐富經驗。在她的領導下,Gamida Cell獲得了美國食品和藥品管理局對Omisirge的批准,這是一種具有突破性的幹細胞療法。Dr. Geffen將支持NurExone的臨床前和臨床活動中的CMC開發。她的貢獻預計包括開發和驗證分析方法,資格評定效力測定方法,優化劑量方案。她還將利用自己的經驗來幫助建立符合行業標準和法規要求的Good Manufacturing Practices生產環境的運營。

Dr. Geffen will support the development of Chemistry, Manufacturing and Controls (CMC) for preclinical and clinical activities at NurExone. Her contributions are expected to include the development and validation of analytical methods, qualification of potency assays, and optimization of dosing regimens. She will also use her experience to help establish operations within Good Manufacturing Practices (GMP) production environments that ensure compliance with industry standards and regulatory requirements.

"我很高興能夠在NurExone的藥物研發週期的這樣一個關鍵時刻加入," Dr. Geffen說。 "ExoPTEN納米藥物在脊髓損傷治療中的創新工作和科學令人印象深刻,我期待爲其在監管和臨床道路上的進展貢獻力量。"

"I am thrilled to join Nurexone at such a pivotal time in their drug development cycle," said Dr. Geffen. "The innovative work and science behind the ExoPTEN nanodrug for spinal cord injury is impressive, and I look forward to contributing to its progress along the regulatory and clinical pathway."

NurExone的研究和開發主任Dr. Noa Avni表示:"Dr. Geffen的專業知識和經驗將在我們開拓生物技術行業和利用外泌體進行再生醫學方面發揮無價之寶。我們歡迎她加入團隊並期待她的貢獻。"

Dr. Noa Avni, NurExone's Director of Research and Development, stated, "Dr. Geffen's expertise and experience will be invaluable as we make strides in the biotech industry and harness the power of exosomes for regenerative medicine. We welcome her to the team and look forward to her contributions."

NurExone生物製品公司是一家在TSX Venture Exchange("TSXV")上市的藥品公司,正在開發一種基於生物導向的外泌體治療平台,用於對中樞神經系統損傷患者的無創輸送。該公司的第一個產品,用於急性脊髓損傷的ExoPTEN,在給予鼻內給藥時,已經證明可以恢復75%實驗室大鼠的運動功能。ExoPTEN已被美國食品和藥品管理局授予孤兒藥物認定。NurExone平台技術有望爲對其他適應症感興趣的藥品公司提供新穎的非侵入性靶向藥物輸送方案。

About NurExone Biologic Inc.

關於NurExone Biologic Inc.

NurExone Biologic Inc. is a TSX Venture Exchange ("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 by the FDA. The NurExone platform technology is expected to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.

電芯生物製品公司是在TSX Venture Exchange("TSXV")上市的一家藥品公司,正在開發一種基於生物導向的外泌體治療平台,用於對中樞神經系統損傷患者的無創輸送。該公司的第一個產品,用於急性脊髓損傷的ExoPTEN,在給予鼻內給藥時,已經證明可以恢復75%實驗室大鼠的運動功能。ExoPTEN已被美國食品和藥品管理局授予孤兒藥物認定。電芯生物製品公司平台技術有望爲對其他適應症感興趣的藥品公司提供新穎的非侵入性靶向藥物輸送方案。

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

獲取更多信息,請訪問或關注NurExoneLinkedIn, 推特, Facebook,或關注 @EVERFI。YouTube.

For more information, please contact:

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
首席執行官和董事
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

Thesis Capital Inc.
灰石資本 - 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

Eva Reuter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

前瞻性聲明"前瞻性聲明"本新聞稿包含某些"前瞻性聲明",反映了公司對其未來結果的當前期望和預測。在可能的情況下,已經使用"可能"、"將"、"應該"、"可以"、"期望"、"計劃"、"打算"、"預期"、"相信"、"估計"、"預測"或"潛在"等詞語或其他類似的詞語或短語來標識這些前瞻性聲明。本新聞稿中的前瞻性聲明包括但不限於與Dr. Geffen的角色和貢獻相關的聲明。

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 Dr. Geffen's role and contributions at the Company; the Company making strides in the biotech industry and harness the power of exosomes for regenerative medicine; and the NurExone platform technology offering novel solutions to drug companies.

本新聞稿包含某些"前瞻性聲明",反映了公司對其未來結果的當前期望和預測。在可能的情況下,已經使用"可能"、"將"、"應該"、"可以"、"期望"、"計劃"、"打算"、"預期"、"相信"、"估計"、"預測"或"潛在"等詞語或其他類似的詞語或短語來標識這些前瞻性聲明。本新聞稿中的前瞻性聲明包括但不限於與Dr. Geffen的角色和貢獻相關的聲明;公司在生物技術領域取得進展並利用外泌體的潛力進行再生醫學聲明;Dr. Geffen的貢獻將產生預期效果;公司將在生物技術領域取得進展並利用外泌體的潛力進行再生醫學。DGeffen 角色和貢獻;公司在生物技術領域取得進展並利用外泌體的潛力進行再生醫學。Geffen; JavelinNurExone平台技術匹配中文沒意義將爲藥品公司提供新穎的解決方案。.

These statements reflect management's current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including the general business and economic conditions of the industries and countries in which we operate; the general market conditions; the ability to secure additional funding; the engagement of Dr. Geffen having its intended outcome; the Company will make strides in the biotech industry and harness the power of exosomes for regenerative medicine; the Company's drug products will have their intended benefits and effects; the Company will make progress using these technologies and move to commercialization of their products; the Company's intellectual property and technology being novel and inventive; the intellectual property having the intended impact on the Company and its business; and the NurExone platform technology will offer novel solutions to drug companies.

這些聲明反映了管理層的當前信念,並基於管理層截至本文日期的當前信息。 本新聞發佈發表前瞻性聲明涉及重大風險、不確定性和假設。 在本新聞發佈中制定前瞻性聲明時,我們應用了幾個重要假設,包括我們經營行業和國家的一般商業和經濟狀況,一般市場條件,獲得其他資金的能力,Dr. Petter的參與產生預期的結果,公司簽訂新的合作伙伴關係和/或授權協議,以及NurExone平台技術將爲藥品公司提供新穎的解決方案。 我們所處行業和國家的一般商業和經濟狀況;一般市場條件 市場條件;獲得其他資金的能力Dr. Petter的參與產生預期的結果 的貢獻將產生預期效果。產生其預期效果; 公司將在生物技術領域取得進展並利用外泌體的潛力進行再生醫學。Geffen; 公司的藥品產品將具有其預期的效益和作用;公司將利用這些技術取得進展並推動其產品的商業化;公司的知識產權和技術是新穎和創新的;知識產權對公司及其業務的影響符合預期;而且NurExone平台技術將爲藥品公司提供新穎的解決方案。將爲藥品公司提供新穎的解決方案。.

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'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 fact that preclinical drug development is uncertain, and the drug product candidates of the Company may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of the Company; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of the Company; the NurExone platform technology being unable to offer novel solutions to drug companies; risks that the Company's intellectual property and technology won't have the intended impact on the Company and/or its business; risks related to the engagement of Dr. Geffen not having its intended outcomes; 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.

前瞻性聲明涉及重大風險、不確定性和假設。許多因素可能導致實際結果與此類前瞻性聲明明顯不同。 業績或成果可能與前瞻性聲明中討論或暗示的結果有實質差異。 這些風險和不確定性包括但不限於以下方面:公司處於早期發展階段;迄今爲止尚無收入;受到政府監管;其產品的市場認可度;技術迅速變化;依賴關鍵人員;保護公司的知識產權;依賴公司的戰略合作伙伴;臨床前藥物開發的不確定性,公司的藥物候選產品可能永遠不會進入臨床試驗;臨床前研究和早期臨床試驗的結果可能無法預測後期臨床試驗的結果;產品開發活動、臨床前研究和臨床試驗的結果具有不確定性;臨床開發過程具有不確定性,包括臨床試驗可能沒有有效的設計或沒有產生積極結果的風險;可能無法獲得或保持公司的藥物候選產品的監管批准;將會推出更安全、更有效或者價格更便宜、更具優勢的競爭性藥物;臨床前研究和臨床試驗的發起、進行和完成可能會受到延遲、不利影響或受到無法預見的問題影響;可能無法獲得足夠的融資;可能無法獲得或無法保持對公司藥物候選產品的知識產權保護; NurExone平台技術可能無法向藥品公司提供新穎的解決方案; 公司的知識產權和技術可能無法對公司及其業務產生預期的影響;有關Geffen博士的僱傭可能沒有預期的結果;and the 請參閱2023年3月30日的公司年度信息表格,第29至36頁下的“風險因素”一節中討論的風險。 這些因素應謹慎考慮,讀者不應過度依賴前瞻性聲明。 投資者應謹慎考慮,並不應過分依賴前瞻性聲明。儘管前瞻性聲明-看待 儘管本新聞稿中的前瞻性聲明基於管理層認爲是合理的假設,但公司不能保證實際結果與這些前瞻性聲明一致。 本新聞稿中的前瞻性聲明基於公司管理層認爲是合理的假設,但實際結果可能與這些前瞻性聲明不一致。 本新聞稿中的前瞻性聲明是在本新聞稿發佈之日作出的,公司不承擔更新或修訂這些聲明以反映新事件或情況的義務,除非法律要求。 本新聞稿中的前瞻性聲明是在本新聞稿發佈之日作出的,公司不承擔更新或修訂這些聲明以反映新事件或情況的義務,除非法律要求。

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

tsxv及其監管服務提供商(如tsxv政策中所定義的那樣)均不承擔本公告的充分性或準確性責任。


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
    搶先評論