On Path to First-in-Human Study, NurExone Engages Prominent Expert in Biological Drug Development
NurExone Biologic announced the engagement of Dr. Yona Geffen as a consultant to enhance its preclinical and clinical activities. Dr. Geffen, an experienced expert from Gamida Cell, will aid in developing Chemistry, Manufacturing, and Controls (CMC) and ensure compliance with Good Manufacturing Practices (GMP). She will contribute to optimizing dosing regimens, developing analytical methods, and qualifying potency assays. This collaboration aims to advance NurExone's ExoPTEN nanodrug for spinal cord injury.
- Engagement of Dr. Yona Geffen, a seasoned expert in biological drug development.
- Dr. Geffen's experience includes FDA approval for a stem cell therapy at Gamida Cell.
- Focus on developing and validating analytical methods and optimizing dosing regimens.
- Expertise in establishing GMP-compliant operations for NurExone's ExoPTEN nanodrug.
- None.
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.
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.
"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."
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."
About 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
For additional information, please visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.
For more information, please contact:
Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com
Thesis Capital Inc.
Investment Relation - Canada
Phone: +1 905-347-5569
Email: IR@nurexone.com
Dr. Eva Reuter
Investment Relation - Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu
FORWARD-LOOKING STATEMENTS
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.
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.
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 www.sedarplus.ca. 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.
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.
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