Vancouver, Canada. April 1, 2019 – NervGen Pharma Corp. (TSX-V: NGEN) (“NervGen” or the “Company”), a regenerative medicine company dedicated to creating innovative solutions for the treatment of nerve damage, today announced the appointment of Amy Franke as the Company’s Vice President, Clinical Operations.
“With the recent successful completion of our Initial Public Offering, we are fully focused on driving our lead drug candidate, NVG-291, into clinical development,” said Dr. Ernest Wong, Chief Executive Officer of NervGen. “With over 20 years of clinical research experience, a strong operational foundation supplemented by program lead expertise and a deep understanding of drug development, we are very excited Amy has joined us to implement the NVG-291 clinical development program as we move toward planned human trials in early 2020.”
Having directly managed 25 clinical trials, including 3 Phase III trials, Ms. Franke has a demonstrated history of executing drug development programs at organizations ranging from fully integrated pharmaceutical companies to early stage biotechnology start-ups as well as in global clinical contract research organizations (CROs). She joins NervGen from Covance Inc., where she was Senior Director, Strategy & Planning. Covance is a global contract research organization that has worked on all of the top 50 best-selling drugs available today. Ms. Franke’s clinical development experience also includes time at the global CRO Parexel International Corp., Novella Clinical (a unit of IQVIA) and OSI Pharmaceuticals which was acquired by Astellas Pharma for $4 billion. Ms. Franke received a Master of Bioethics degree from the University of Pennsylvania School of Medicine and a Bachelor of Science, Cellular and Molecular Biology, from the University of Michigan.
Advancement of NVG-291
NervGen is advancing its lead compound NVG-291 toward human clinical studies for the treatment of spinal cord injury (“SCI”). The Company believes this indication is a significant opportunity due to the current lack of non-surgical solutions in the market, the dramatic impact on quality of life and the high cost burden to the healthcare system. According to data retrieved from the National Spinal Cord Injury Statistical Center, approximately 17,000 new SCI occur each year which would place the number of SCI patients whose injuries are six months old or less below the 200,000 threshold for orphan drug designation. Management believes NVG-291 as a therapy could alleviate or improve upon the symptoms and conditions associated with acute spinal cord injury and empower SCI patients to live more active and productive lives.
NervGen plans to initiate a clinical trial for NVG-291 beginning in 2020 under an Investigational New Drug (“IND”) application with the US Food and Drug Administration (“FDA”). The Company intends to complete required pre-clinical non-human studies in 2019 and plans to meet with the FDA in a pre-IND meeting to review its plans for submission of the IND. NVG-291 is manufactured using well established peptide synthesis procedures. Materials to be used in human clinical trials planned for early 2020 will be manufactured by an approved contract manufacturing organization (“CMO”) under current Good Manufacturing Practices guidelines enforced by the FDA. Several batches of NVG-291 have been successfully manufactured.
NervGen Pharma Corp. is a regenerative medicine company dedicated to the advancement of innovative therapeutics for the treatment of nerve damage, including spinal cord injuries (“SCI”) and peripheral nerve injuries (“PNI”). The Company plans to create revolutionary technologies that promote nerve regeneration. The Company will identify, evaluate and develop other drug candidates for other medical conditions arising from nerve damage.
Cautionary Note Regarding Forward-Looking Statements
This news release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian and United States securities legislation. Such forward-looking statements and information herein include but are not limited to statements regarding the trading of NervGen’s common shares on the TSX-V, the intended use of the proceeds of the IPO and the development of the NVG-291 compound for nerve regeneration.
Forward looking statements: Certain statements in this document about the Company’s current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements or any other future events or developments constitute forward-looking statements, including, without limitation, statements regarding the use of proceeds of the IP, advancement of NVC-291 toward clinical development and commercialization, the timing of human trials and regulatory approval, the potential efficacy of the Company’s products and technology, and the potential to identify, evaluate and develop other drug candidates. The words “may”, “will”, “would”, “should”, “could”, “expect”, “plan”, “intend”, “trend”, “indication”, “anticipate”, “believe”, “estimate”, “predict”, “likely” or “potential”, or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements are based on estimates and assumptions made by the Company in light of management’s experience and perception of historical trends, current conditions and expected future developments, as well as other factors that the Company believes are appropriate and reasonable in the circumstances. Many factors could cause the Company’s actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements, including , without limitation, a lack of revenue, insufficient funding, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the “Risk Factors” section of the Final Prospectus which can be found on SEDAR.com including the Company’s Management Discussion and Analysis for the period from incorporation on January 19, 2017 to December 31, 2017. Readers should not place undue reliance on forward-looking statements made in this document. Furthermore, unless otherwise stated, the forward-looking statements contained in this document are made as of the date of this document, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this document are expressly qualified by this cautionary statement.
For further information, please contact:
Bill Radvak, Executive Chairman
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