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NervGen Appoints John Ruffolo To Board Of Directors, Receives Fast Track Designation For NVG-291
Friday, October 27, 2023Company Profile | Follow Company
Vancouver, BC, October 25, 2023--(T-Net)--NervGen Pharma Corp. (TSX-V: NGEN; OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today announced the appointment of John Ruffolo, Founder and Managing Partner of Maverix Private Equity to the Company's Board of Directors.
Bill Radvak, Chairman, NervGen Pharma Corp.
"We very much appreciate John joining our Board at this pivotal time as we continue with our landmark Phase 1b/2a clinical trial for spinal cord injury," said Bill Radvak, NervGen's Chairman & Co-Founder.
"Not only does he deliver substantial expertise in finance and developing leading-edge technologies, he also brings the very unfortunate experience of surviving a tragic accident, which resulted in severe injuries including a spinal cord injury. John's relentless drive has resulted in a remarkable level of recovery from his injuries as well as gaining an incredible wealth of knowledge on spinal cord injury research and treatments."
"I have been closely following NervGen and its very important drug, NVG-291, for some time and am excited that it is now being administered to individuals with spinal cord injury in this important clinical trial," said Mr. Ruffolo. "As someone who experiences daily the life-altering impact of a spinal cord injury, it is thrilling to finally see NVG-291 in the clinic with the potential to demonstrate nervous system repair. I look forward to doing my part to drive NervGen forward and to help realize the potential of this important technology."
John Ruffolo is the Founder and Managing Partner of Maverix Private Equity, a private equity firm focused on innovation-enabled growth and disruption investment strategies. Previously he founded OMERS Ventures, the venture capital arm of the large Ontario pension fund where he led early investments in startup success stories such as Shopify Inc.
He has also championed Canada's technology industry as a co-founder of the Council of Canadian Innovators, along with former Research in Motion co-CEO Jim Balsillie. As an active board member in the profit and not-for-profit sectors, John currently works with many leading innovative organizations including AI Partnerships Corp., engineering.com, OneEleven, the Rick Hansen Foundation, the CIBC Foundation, Caldwell's Top 40 Under 40, the Investigative Journalism Foundation, and the Dean's Global Council for the Schulich School of Business.
The Company also announced that it has granted 150,000 incentive stock options to Mr. Ruffolo exercisable at a price of $1.75 per share for a period of five years and that vest equally every three months over a one-year period. All options have been granted in accordance with the policies of the TSX Venture Exchange and the conditions of the Company's stock option plan.
NervGen Pharma also announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI).
FDA's Fast Track program is designed to facilitate the development of drugs intended to treat serious conditions and fill unmet medical needs as part of the FDA's goal to get important new drugs to patients earlier. Fast Track also provides eligibility for both Priority Review, which can shorten the New Drug Development (NDA) review process, and for Accelerated Approval, which can allow for an earlier or faster approval based on a surrogate or intermediate clinical endpoint.
Mike Kelly, President and Chief Executive Officer, NervGen Pharma Corp.
"The FDA's decision to grant Fast Track designation for NVG-291 underscores the significance and severity of the unmet medical need that exists for individuals living with spinal cord injury and their caregivers," said Mike Kelly, NervGen's President & CEO. "We believe that NVG-291 has the potential to be the first approved treatment indicated to enable neurological/functional recovery following spinal cord injury, and we look forward to working closely with the FDA in the clinical development process with the goal of obtaining approval to market NVG-291 as soon as possible."
About Fast Track Designation
Fast Track designation is intended to facilitate development and expedite review of drugs to treat serious or life-threatening conditions so that a product can reach the market expeditiously. A drug that is intended to treat a serious or life-threatening condition that demonstrates the potential to address an unmet medical need may qualify for Fast Track designation. Features of this designation include opportunities for frequent interactions with the review team. These include meetings with the FDA to discuss items such as study design, extent of safety data required to support approval, dose-response concerns, accelerated approval, the structure and content of an NDA, and other critical issues. In addition, such a product could be eligible for priority review if supported by clinical data at the time of NDA.
About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting mechanisms that interfere with nervous system repair. NVG-291 is derived from the intracellular wedge domain of the receptor type protein tyrosine phosphatase sigma (PTPs). NVG-291-R, a rodent analog of NVG-291, has been shown to promote nervous system repair and functional recovery in animal models of spinal cord injury (acute and chronic intervention), peripheral nerve injury, multiple sclerosis and stroke, through enhanced plasticity, axonal regeneration, and remyelination.
NervGen has initiated a Phase 1b/2a placebo-controlled proof-of-concept trial (NCT05965700) to evaluate the efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (10-49 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. Initial results are expected in mid-2024.
About NervGen
NervGen (TSX-V: NGEN, OTCQX: NGENF) is a clinical stage biotech company dedicated to developing innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. NervGen's lead drug candidate, NVG-291, is being evaluated in a Phase 1b/2a clinical trial. The Company's initial target indication is spinal cord injury. For more information, go to www.nervgen.com and follow NervGen on Twitter, LinkedIn, and Facebook for the latest news on the Company.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. 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: our development programs, including the development of NVG-291; our research for the treatment of spinal cord injury, multiple sclerosis, Alzheimer's disease and other neurodegenerative applications; and the use of proceeds of the Offering. [ MORE ] |
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