NervGen Pharma to Present at the 63rd International Spinal Cord Society Annual Scientific Meeting
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company, announced that its Chief Medical Officer, Dr. Daniel Mikol, will present at the 63rd International Spinal Cord Society (ISCoS) Annual Scientific Meeting in Antwerp, Belgium, on September 23, 2024. Dr. Mikol will provide a clinical trial update on the Phase 1b/2a study of NVG-291 in individuals with subacute or chronic spinal cord injury (SCI).
The presentation will cover the trial design, rationale for evaluating clinical and electrophysiological measures, and baseline characteristics of randomized subjects. NVG-291 has shown promise in preclinical studies for promoting functional recovery through neural repair mechanisms. The company hopes that the trial results will demonstrate the potential of NVG-291 to enable neural repair in SCI patients and support further investigation.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), una compagnia biotech in fase clinica, ha annunciato che il suo Chief Medical Officer, Dr. Daniel Mikol, terrà una presentazione al 63° Congresso Annuale della Società Internazionale del Midollo Spinale (ISCoS) ad Anversa, Belgio, il 23 settembre 2024. Il Dr. Mikol fornirà un aggiornamento sui trial clinici riguardanti lo studio di Fase 1b/2a di NVG-291 in individui con lesioni del midollo spinale subacute o croniche (SCI).
La presentazione tratterà il design dello studio, le motivazioni per la valutazione delle misure cliniche ed elettrofisiologiche, e le caratteristiche di base dei soggetti randomizzati. NVG-291 ha mostrato risultati promettenti negli studi preclinici per promuovere il recupero funzionale attraverso meccanismi di riparazione neurale. La società spera che i risultati dello studio dimostrino il potenziale di NVG-291 di abilitare la riparazione neurale nei pazienti con SCI e sostenere ulteriori indagini.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), una compañía biotecnológica en etapa clínica, ha anunciado que su Director Médico, Dr. Daniel Mikol, presentará en el 63º Congreso Anual de la Sociedad Internacional de Médula Espinal (ISCoS) en Amberes, Bélgica, el 23 de septiembre de 2024. El Dr. Mikol proporcionará una actualización sobre el ensayo clínico del estudio de Fase 1b/2a de NVG-291 en personas con lesión medular subaguda o crónica (SCI).
La presentación cubrirá el diseño del ensayo, la justificación para evaluar medidas clínicas y electrofisiológicas, y las características de base de los sujetos aleatorizados. NVG-291 ha mostrado promesas en estudios preclínicos al promover la recuperación funcional a través de mecanismos de reparación neuronal. La compañía espera que los resultados del ensayo demuestren el potencial de NVG-291 para habilitar la reparación neuronal en los pacientes con SCI y respalden investigaciones adicionales.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), 임상 단계의 생명공학 회사가 벨기에 안트베르펜에서 2024년 9월 23일에 열리는 제63회 국제 척수학회(ISCoS) 연례 학술 대회에서 최고 의료 책임자 Dr. Daniel Mikol이 발표할 것이라고 발표했습니다. Mikol 박사는 아급성 또는 만성 척수 손상이 있는 개인을 대상으로 한 NVG-291의 1b/2a 단계 연구에 대한 임상 시험 업데이트를 제공할 것입니다.
발표는 시험 설계, 임상 및 전기 생리학적 측정 평가의 이유, 무작위 선정된 피험자의 기초 특성에 대해 다룰 것입니다. NVG-291은 신경 회복 메커니즘을 통해 기능적 회복을 촉진하는 데 유망한 결과를 보였습니다. 회사는 시험 결과가 NVG-291이 SCI 환자에서 신경 회복을 가능하게 할 잠재력이 있음을 보여주고 추가 조사를 지원할 것이라고 기대하고 있습니다.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), une société biopharmaceutique en phase clinique, a annoncé que son directeur médical, Dr. Daniel Mikol, présentera lors de la 63e Réunion Scientifique Annuelle de la Société Internationale de la Moelle Épinière (ISCoS) à Anvers, en Belgique, le 23 septembre 2024. Dr. Mikol fournira une mise à jour sur l'essai clinique du étude de Phase 1b/2a de NVG-291 chez des individus ayant subi une lésion médullaire subaiguë ou chronique (SCI).
La présentation couvrira le design de l'essai, les raisons de l'évaluation des mesures cliniques et électrophysiologiques, ainsi que les caractéristiques de base des sujets randomisés. NVG-291 a montré un potentiel prometteur dans des études précliniques pour favoriser la récupération fonctionnelle par des mécanismes de réparation neuronale. La société espère que les résultats de l'essai démontreront le potentiel de NVG-291 à permettre la réparation neuronale chez les patients atteints de SCI et soutenir des recherches supplémentaires.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), ein biotechnologisches Unternehmen in der klinischen Phase, hat angekündigt, dass der Chief Medical Officer, Dr. Daniel Mikol, beim 63. Internationalen Kongress der Spinal Cord Society (ISCoS) in Antwerpen, Belgien, am 23. September 2024 präsentieren wird. Dr. Mikol wird ein Update zur klinischen Studie über die Phase 1b/2a Studie von NVG-291 bei Personen mit subakuter oder chronischer Rückenmarkverletzung (SCI) geben.
Die Präsentation wird das Studiendesign, die Begründung für die Bewertung klinischer und elektrophysiologischer Maßnahmen sowie die Grundmerkmale der randomisierten Probanden behandeln. NVG-291 hat in vorklinischen Studien vielversprechende Ergebnisse gezeigt, indem es die funktionelle Genesung durch neuronale Reparaturmechanismen fördert. Das Unternehmen hofft, dass die Studienergebnisse das Potenzial von NVG-291 zeigen, die neuronale Reparatur bei SCI-Patienten zu ermöglichen und weitere Untersuchungen zu unterstützen.
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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 (PTPσ). 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.
Contacts
Huitt Tracey, Corporate Communications
htracey@nervgen.com
604.537.2094
Bill Adams, Chief Financial Officer
info@nervgen.com
778.731.1711
David Schull or Ignacio Guerrero-Ros, Ph.D.
Russo Partners
david.schull@russopartnersllc.com
ignacio.guerrero-ros@russopartnersllc.com
858.717.2310
646.942.5604
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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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