Vancouver, Canada. September 6, 2019 – NervGen Pharma Corp. (TSX-V: NGEN) (OTCQX: NGENF) (“NervGen” or the “Company”), a regenerative medicine company dedicated to creating innovative solutions for the treatment of nerve damage and neurodegenerative diseases, today announced the clinical development strategy for its compound, NVG-291, in two lead indications: spinal cord injury and multiple sclerosis. The NVG-291 clinical development program is planned as follows:
- the Phase 1 safety and pharmacokinetic study in healthy subjects currently remains on track to commence in the first quarter of 2020 as originally scheduled;
- a cohort of spinal cord injury patients, an expansion of the Company’s Phase 1 trial, is scheduled to commence in the second half of 2020; and,
- a Phase 2 multiple sclerosis trial is scheduled to commence in the first quarter of 2021.
“While we continue to evaluate the potential of our platform in additional indications, over the next 24 months we will focus on aggressively advancing the clinical programs for NVG-291 in spinal cord injury and multiple sclerosis,” stated Ernest Wong, PhD, NervGen’s President & CEO.
The main purpose of the initial portion of the Phase I study in healthy subjects will be to explore safety and dosing parameters of NVG-291. This data will enable the evaluation of NVG-291 in patients. The Company intends to file its Investigational New Drug application with the U.S. Food and Drug Administration in Q4 2019 and expects enrollment of between 40 and 75 healthy human subjects in the Phase 1 study.
The Company also reports the results of its annual general meeting of shareholders held on September 5, 2019. At the meeting, the shareholders set the number of directors at five and re-elected to its Board of Directors, Michael Abrams, Brian Bayley, Harold Punnett, William Radvak and Ernest Wong to serve in office until the next annual meeting or until their successors are duly elected or appointed.
In addition, the shareholders voted in favor of the appointment of Davidson & Company LLP, Chartered Accountants, as auditors of the Company and certain amendments to the Company’s existing stock option plan.
NervGen is restoring life’s potential by creating innovative solutions for the treatment of nerve damage and neurodegenerative diseases. The Company is developing drugs for both spinal cord injury and multiple sclerosis. The Company also continues to research other indications such as Alzheimer’s, stroke, acute myocardial infarction induced arrhythmia (“AMI”, commonly known as a heart attack) and other neurodegenerative diseases.
NervGen plans to submit an Investigational New Drug application with the U.S. Food and Drug Administration with the intention of initiating a Phase 1 human clinical trial for its lead compound, NVG-291, in early 2020. NervGen is advancing NVG-291 for the treatment of spinal cord injury and multiple sclerosis as the Company believes these indications are significant opportunities in the market, the dramatic impact on quality of life and the high cost burden to the healthcare system. The Company believes NVG-291, as a therapy, could alleviate or improve upon the symptoms and conditions associated with spinal cord injury and multiple sclerosis, and empower these patients to live more active and productive lives.
For further information, please contact:
Huitt Tracey, Corporate Communications
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This news release may contain “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 advancement of NVG-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.
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