Vancouver, Canada. April 22, 2021 – NervGen Pharma Corp. (TSX-V: NGEN) (OTCQX: NGENF) (“NervGen” or the “Company”), a biotech company dedicated to creating innovative solutions for the treatment of nerve damage and neurodegenerative diseases, is pleased to announce the appointment of Daniel Mikol, MD, PhD, as the Company’s Chief Medical Officer, effective May 5th, 2021. Dr. Mikol, who currently holds the position of Executive Medical Director, Global Clinical Development at Amgen, will oversee NervGen’s medical and clinical activities, with a primary focus on NervGen’s lead product, NVG-291, which is initially being developed to treat multiple sclerosis, Alzheimer’s disease and spinal cord injury.
“We are thrilled to welcome Dan to NervGen,” stated Paul Brennan, President & CEO of NervGen. “Dan’s expertise in neurology and neuroscience research, and the clinical development of neuroscience products in the pharmaceutical industry will be an immeasurable benefit to NervGen as we start our clinical trials. Dan’s experiences at Amgen, Biogen and Novartis in dealing directly with the FDA, European authorities (CHMP, ODD, and at country level), Health Canada, and Japan (PMDA) will be key to guiding the optimal clinical development for NVG-291. Furthermore, his proven track record in developing multiple sclerosis products at EMD Serono, Novartis and Biogen is particularly relevant to NVG-291.”
“I am extremely excited to be joining NervGen at this critical time in the development of its lead product and its PTPσ inhibitor platform,” said Dr. Mikol. “What has drawn me to NervGen is the large extent of scientific data supporting the importance of this target in inhibiting nerve repair and the opportunity to lead the clinical development of a program and platform that can be truly revolutionary for treating patients with nerve damage. The potential for NVG-291 to help patients with multiple sclerosis, Alzheimer’s disease and spinal cord injury is truly inspiring, and I look forward to playing a lead role in making this happen.”
Dr. Mikol is Board Certified Neurologist with 13 years of pharmaceutical industry experience focused on neurodegenerative diseases. Currently, Dr. Mikol holds the position of Executive Medical Director, Global Clinical Development at Amgen in Thousand Oaks, California where he is the global development therapeutic area head for neuroscience and nephrology, and head of the molecular genetic team for all therapeutic areas. At Amgen, Dr. Mikol was instrumental as a development lead in achieving regulatory approval of erenumab for migraine prevention. Prior to working at Amgen, Dr. Mikol was a Senior Medical Director at Biogen, where amongst other responsibilities, he was the clinical development lead for natalizumab (Tysabri) and helped Biogen in gaining their Japanese (PMDA) approval for relapsing multiple sclerosis. Dr. Mikol has also held positions at Novartis and EMD Serono where he worked with, amongst other therapies, fingolomid, cladribine and interferon-ß-1a. Dr. Mikol was educated at the University of Chicago for both his MD and PhD, and was a Fulbright Scholar, Immunological Research, Ludwig Maximilian University of Munich, Germany. He held a staff physician role treating patients for 12 years at The University of Michigan, Department of Neurology.
NVG-291 is an inhibitor of PTPσ, a promising target for reducing the clinical effects of nerve damage, either as a result of trauma, such as in the case of spinal cord injury, traumatic brain injury or stroke, or neurodegenerative diseases, such as multiple sclerosis or Alzheimer’s disease. NervGen believes that inhibiting the activity of PTPσ has the potential to promote nerve repair mechanisms such as nerve regeneration, remyelination and plasticity; promote autophagy, a cellular self-cleaning mechanism; and to promote a non-inflammatory phenotype in microglia cells, the innate immune cells of the brain.
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 the treatment of multiple sclerosis, spinal cord injury and Alzheimer’s disease. NervGen’s platform technology targets protein tyrosine phosphatase sigma (“PTPσ”), a neural receptor that impedes nerve repair. Inhibition of the PTPσ receptor has been shown to promote regeneration and remyelination of damaged nerves, as well as improvement of nerve function in animal models for various medical conditions.
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Cautionary Note Regarding Forward-Looking Statements
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, and 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 include, without limitation, statements relating to: the clinical development of NVG-291; the expected benefits from Dr. Mikol’s experience in the clinical development of NVG-291; our belief that the NVG-291 program and platform can be truly revolutionary for treating patients with nerve damage; the potential for NVG-291 to help patients with multiple sclerosis, Alzheimer’s disease and spinal cord injury; our belief that inhibiting the activity of PTPσ is a promising target for reducing the clinical effects of nerve damage through multiple mechanisms; steps taken to minimize the impact of the COVID-19 pandemic on our operations; and the creation of innovative solutions for the treatment of nerve damage and neurodegenerative diseases.
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 we believe are appropriate and reasonable in the circumstances. In making forward-looking statements, the Company has relied on various assumptions, including, but not limited to: the Company’s ability to manage the effects of the COVID-19 pandemic; the accuracy of the Company’s financial projections; the Company obtaining positive results in its clinical and other trials; the Company obtaining necessary regulatory approvals; and general business, market and economic conditions.
Many factors could cause our 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, the impact of the COVID-19 pandemic, 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 Annual Information Form, Amended and Restated Prospectus Supplement, financial statements and Management Discussion and Analysis which can be found on SEDAR.com. All clinical development plans are subject to additional funding.
Readers should not place undue reliance on forward-looking statements made in this news release. Furthermore, unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and we have no intention and undertake 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 news release are expressly qualified by this cautionary statement.