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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

在进行首例人体研究时,NurExone聘请了杰出的生物药物开发专家
GlobeNewswire ·  06/21 16:04

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生物制品公司(TSXV:NRX,OTCQB: NRXBF,Germany:J90)是一家开创性的生物制药公司,欢迎Dr. Yona Geffen加入公司作为顾问,支持NurExone的临床前和临床活动。Dr. Geffen目前担任Gamida Cell Ltd.的研发副总裁,拥有在生物技术和药品行业领导临床和药物开发方面超过20年的丰富经验。在她的领导下,Gamida Cell获得了美国食品和药品管理局对Omisirge的批准,这是一种具有突破性的干细胞疗法。Dr. Geffen将支持NurExone的临床前和临床活动中的CMC开发。她的贡献预计包括开发和验证分析方法,资格评定效力测定方法,优化剂量方案。她还将利用自己的经验来帮助建立符合行业标准和法规要求的Good Manufacturing Practices生产环境的运营。

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.

"我很高兴能够在NurExone的药物研发周期的这样一个关键时刻加入," Dr. Geffen说。 "ExoPTEN纳米药物在脊髓损伤治疗中的创新工作和科学令人印象深刻,我期待为其在监管和临床道路上的进展贡献力量。"

"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的研究和开发主任Dr. Noa Avni表示:"Dr. Geffen的专业知识和经验将在我们开拓生物技术行业和利用外泌体进行再生医学方面发挥无价之宝。我们欢迎她加入团队并期待她的贡献。"

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生物制品公司是一家在TSX Venture Exchange("TSXV")上市的药品公司,正在开发一种基于生物导向的外泌体治疗平台,用于对中枢神经系统损伤患者的无创输送。该公司的第一个产品,用于急性脊髓损伤的ExoPTEN,在给予鼻内给药时,已经证明可以恢复75%实验室大鼠的运动功能。ExoPTEN已被美国食品和药品管理局授予孤儿药物认定。NurExone平台技术有望为对其他适应症感兴趣的药品公司提供新颖的非侵入性靶向药物输送方案。

About NurExone Biologic Inc.

关于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.

电芯生物制品公司是在TSX Venture Exchange("TSXV")上市的一家药品公司,正在开发一种基于生物导向的外泌体治疗平台,用于对中枢神经系统损伤患者的无创输送。该公司的第一个产品,用于急性脊髓损伤的ExoPTEN,在给予鼻内给药时,已经证明可以恢复75%实验室大鼠的运动功能。ExoPTEN已被美国食品和药品管理局授予孤儿药物认定。电芯生物制品公司平台技术有望为对其他适应症感兴趣的药品公司提供新颖的非侵入性靶向药物输送方案。

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

获取更多信息,请访问或关注NurExoneLinkedIn, 推特, Facebook,或关注 @EVERFI。YouTube.

For more information, please contact:

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
首席执行官和董事
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

Thesis Capital Inc.
灰石资本 - 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

Eva Reuter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

前瞻性声明"前瞻性声明"本新闻稿包含某些"前瞻性声明",反映了公司对其未来结果的当前期望和预测。在可能的情况下,已经使用"可能"、"将"、"应该"、"可以"、"期望"、"计划"、"打算"、"预期"、"相信"、"估计"、"预测"或"潜在"等词语或其他类似的词语或短语来标识这些前瞻性声明。本新闻稿中的前瞻性声明包括但不限于与Dr. Geffen的角色和贡献相关的声明。

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.

本新闻稿包含某些"前瞻性声明",反映了公司对其未来结果的当前期望和预测。在可能的情况下,已经使用"可能"、"将"、"应该"、"可以"、"期望"、"计划"、"打算"、"预期"、"相信"、"估计"、"预测"或"潜在"等词语或其他类似的词语或短语来标识这些前瞻性声明。本新闻稿中的前瞻性声明包括但不限于与Dr. Geffen的角色和贡献相关的声明;公司在生物技术领域取得进展并利用外泌体的潜力进行再生医学声明;Dr. Geffen的贡献将产生预期效果;公司将在生物技术领域取得进展并利用外泌体的潜力进行再生医学。DGeffen 角色和贡献;公司在生物技术领域取得进展并利用外泌体的潜力进行再生医学。Geffen; JavelinNurExone平台技术匹配中文没意义将为药品公司提供新颖的解决方案。.

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.

这些声明反映了管理层的当前信念,并基于管理层截至本文日期的当前信息。 本新闻发布发表前瞻性声明涉及重大风险、不确定性和假设。 在本新闻发布中制定前瞻性声明时,我们应用了几个重要假设,包括我们经营行业和国家的一般商业和经济状况,一般市场条件,获得其他资金的能力,Dr. Petter的参与产生预期的结果,公司签订新的合作伙伴关系和/或授权协议,以及NurExone平台技术将为药品公司提供新颖的解决方案。 我们所处行业和国家的一般商业和经济状况;一般市场条件 市场条件;获得其他资金的能力Dr. Petter的参与产生预期的结果 的贡献将产生预期效果。产生其预期效果; 公司将在生物技术领域取得进展并利用外泌体的潜力进行再生医学。Geffen; 公司的药品产品将具有其预期的效益和作用;公司将利用这些技术取得进展并推动其产品的商业化;公司的知识产权和技术是新颖和创新的;知识产权对公司及其业务的影响符合预期;而且NurExone平台技术将为药品公司提供新颖的解决方案。将为药品公司提供新颖的解决方案。.

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.

前瞻性声明涉及重大风险、不确定性和假设。许多因素可能导致实际结果与此类前瞻性声明明显不同。 业绩或成果可能与前瞻性声明中讨论或暗示的结果有实质差异。 这些风险和不确定性包括但不限于以下方面:公司处于早期发展阶段;迄今为止尚无收入;受到政府监管;其产品的市场认可度;技术迅速变化;依赖关键人员;保护公司的知识产权;依赖公司的战略合作伙伴;临床前药物开发的不确定性,公司的药物候选产品可能永远不会进入临床试验;临床前研究和早期临床试验的结果可能无法预测后期临床试验的结果;产品开发活动、临床前研究和临床试验的结果具有不确定性;临床开发过程具有不确定性,包括临床试验可能没有有效的设计或没有产生积极结果的风险;可能无法获得或保持公司的药物候选产品的监管批准;将会推出更安全、更有效或者价格更便宜、更具优势的竞争性药物;临床前研究和临床试验的发起、进行和完成可能会受到延迟、不利影响或受到无法预见的问题影响;可能无法获得足够的融资;可能无法获得或无法保持对公司药物候选产品的知识产权保护; NurExone平台技术可能无法向药品公司提供新颖的解决方案; 公司的知识产权和技术可能无法对公司及其业务产生预期的影响;有关Geffen博士的雇佣可能没有预期的结果;and the 请参阅2023年3月30日的公司年度信息表格,第29至36页下的“风险因素”一节中讨论的风险。 这些因素应谨慎考虑,读者不应过度依赖前瞻性声明。 投资者应谨慎考虑,并不应过分依赖前瞻性声明。尽管前瞻性声明-看待 尽管本新闻稿中的前瞻性声明基于管理层认为是合理的假设,但公司不能保证实际结果与这些前瞻性声明一致。 本新闻稿中的前瞻性声明基于公司管理层认为是合理的假设,但实际结果可能与这些前瞻性声明不一致。 本新闻稿中的前瞻性声明是在本新闻稿发布之日作出的,公司不承担更新或修订这些声明以反映新事件或情况的义务,除非法律要求。 本新闻稿中的前瞻性声明是在本新闻稿发布之日作出的,公司不承担更新或修订这些声明以反映新事件或情况的义务,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及其监管服务提供商(如tsxv政策中所定义的那样)均不承担本公告的充分性或准确性责任。


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