Vancouver, B.C. April 24, 2019 NervGen Pharma Corp. (“NervGen”) (TSX.V: NGEN), a regenerative medicine company dedicated to creating innovative solutions for the treatment of nerve damage, announces the issuance by the U.S. Patent and Trademark Office of two new patents protecting the development and commercialization of protein tyrosine phosphatase sigma (PTPs) targeted therapies for heart diseases and injury, and for root avulsion involving injuries into the peripheral nerve system.
“The issuance of these patents strengthens our intellectual property estate by expanding protections to various diseases and medical conditions where our technology has demonstrated strong preclinical efficacy,” said Dr. Ernest Wong, President & CEO of NervGen. “We continue to aggressively prosecute the patent portfolio acquired through our 2018 license with Case Western Reserve University as we continue to build evidence for the potential of our NVG-291 therapy to positively impact various conditions in addition to spinal cord injury.”
Patent, US 10,206,967, entitled “Compositions and Methods for Treating Heart Diseases and/or Injury”, includes claims covering both composition of matter and method of use for promoting and restoring innervation of myocardial tissue. It covers treatment of heart diseases and injury by administering a therapeutic agent, such as NVG-291, the intracellular sigma peptide (“ISP”) and other related peptides, that inhibit the activity, signaling and/or function of the PTPs receptor. In a mouse model of myocardial infarct, PTPs targeted therapy was shown to induce regeneration of sympathetic nerve fibers into the scar, resulting in the cessation of arrhythmia.
The second patent, US 10,258,672, issued recently is entitled “Compositions and Methods for Treating Root Avulsion”. It includes claims covering composition of matter and method of use for treating root avulsion, which is a physical separation of the motor and/or sensory nerves from the spinal cord, leading to severe disruption of the root itself as well as the associated spinal cord segment. PTPs targeted therapy has been shown in rodent models to induce axonal growth between the central nervous system and the peripheral nervous system with subsequent robust improvement in both motor and sensory functions.
Advancement of NVG-291
NervGen is advancing its lead compound NVG-291 toward human clinical studies for the treatment of spinal cord injury. 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. Management believes NVG-291 as a therapy could alleviate or improve upon the symptoms and conditions associated with acute spinal cord injury and empower 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 under current Good Manufacturing Practices guidelines enforced by the FDA. Several batches of NVG-291 have been successfully manufactured.
ABOUT NERVGEN
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 and peripheral nerve injuries. 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 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 financings, 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 Company’s Prospectus, financial statements and Management Discussion and Analysis which can be found on SEDAR.com. 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
bradvak@nervgen.com
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