Vancouver, British Columbia--(Newsfile Corp. - September 16, 2024) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, announced today that Daniel Mikol, MD, Ph.D., NervGen's Chief Medical Officer, will present at the 63rd International Spinal Cord Society (ISCoS) Annual Scientific Meeting, taking place on September 22-25, 2024, in Antwerp, Belgium.
The ISCoS Annual Scientific Meeting is a global pivotal event for professionals specializing in spinal cord injury (SCI), encompassing prevention, research, management, and rehabilitation, that serves as a forum for clinicians and researchers to discuss the latest developments in the highest standard of care and treatments and foster collaboration in an interdisciplinary gathering. Dr. Mikol will present "Clinical Trial Update: Phase 1b/2a Study of NVG-291 in Individuals with Subacute or Chronic SCI" during the Oral Presentations 4 session on Monday, September 23, from 4:40 p.m. to 6 p.m. CEST, at the Flanders Meeting and Convention Centre. During this clinical trial update, Dr. Mikol will review the trial design, the rationale for evaluating not just clinical outcome measures but also electrophysiological measures as biomarkers of efficacy, and will provide an update on the baseline demographic and clinical characteristics of subjects randomized.
Dr. Mikol stated, "Preclinical studies in SCI animal models have shown that NVG-291-R can promote functional recovery through neural repair mechanisms like enhanced plasticity. In this first clinical trial of NVG-291 in SCI, we have incorporated both clinical assessments as well as electrophysiological assessments of connectivity, as we feel this gives the highest probability of observing and characterizing an efficacy signal with NVG-291. We are hopeful that the results of the Phase 1b/2a trial may demonstrate, for the first time, the potential for NVG-291 to enable neural repair in individuals with SCI and will support further investigation of NVG-291 in SCI."
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. NVG-291 has received Fast Track Designation in spinal cord injury from the U.S. Food and Drug Administration.
About Phase 1b/2a Trial
The double-blind, placebo-controlled proof-of-concept trial (NCT05965700) will 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 (those with a more recent injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. Specifically, the primary objective is to assess the change in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment based on changes in motor evoked potential amplitudes. Secondary objectives are to evaluate changes in a number of clinical outcome assessments focusing on motor function, upper extremity dexterity and grasping and mobility, as well as changes in additional electrophysiological measurements. Each cohort will be evaluated independently as the data becomes available. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments that will offset a portion of the direct costs of this clinical trial.
About NervGen
NervGen (TSXV: NGEN, OTCQB: NGENF) is a clinical-stage biotech company dedicated to developing innovative treatments that enable the nervous system to repair itself in the settings of traumatic injury and disease. NervGen's lead drug candidate, NVG-291, is being evaluated in a Phase 1b/2a clinical trial in the company's initial target indication, spinal cord injury. The company has initiated preclinical evaluation of a new development candidate, NVG-300, in models of ischemic stroke, amyotrophic lateral sclerosis (ALS) and spinal cord injury. For more information, visit www.nervgen.com and follow NervGen on X, LinkedIn, and Facebook for the latest news on the company.
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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 subject matter to be presented at the upcoming conference; the objectives, timing and study design of the clinical development of NVG-291 in spinal cord injury; the rationale for the use of electrophysiological assessments of connectivity as an efficacy biomarker in our proof-of-concept trial; the receipt of the milestone-based grant payments; the development plans and prospective target indications for NVG-300; and the creation of innovative treatments of nervous system damage due to trauma or disease.
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