According to the Centers for Disease Control and Prevention an estimated 3.4 million Americans have epilepsy, and 25 to 35 percent live with ongoing seizures despite treatment with approved drugs, illustrating a huge unmet medical need in this community. NRTX-1001 is manufactured in Neuronas in-house GMP facility using proprietary methods. Supported by these promising data, Neurona is initiating a first ever clinical trial of human cell therapy for epilepsy. Rationale: At least one-third of people with epilepsy have seizures that are drug-resistant.Anti-seizure drugs that potentiate the inhibitory neurotransmitter GABA provide potent seizure suppression, but their use is limited by the development of side effects, tolerance, and the potential for abuse. Neurona is a clinical-stage biotherapeutics company developing regenerative cell therapies that permanently integrate into neural circuits, replace affected cells, and rebalance dysregulated electrical activity to repair the nervous system. Preclinical-Development-of-NRTX-1001--an-Inhibitory-Interneuron dvelopper et amliorer nos produits et services. Separately, in an oral session, Dr. Nicholas will present data demonstrating that the NRTX-1001 interneurons stably persisted in a preclinical MTLE model, reproducibly eliminated focal seizures in the majority of the treatment group, reduced temporal lobe tissue damage, and improved survival rates. Neurona has pioneered a novel inhibitory neuron cell therapy candidate and generated compelling preclinical efficacy data. Neuronas proprietary regenerative cell technology is based on research by the companys founders at the University of California, San Francisco. Industry, government and academic . About Neuronas Clinical Trial of NRTX-1001 for Mesial Temporal Lobe Epilepsy (MTLE)Neuronas multicenter, Phase I/II clinical trial is designed to evaluate the safety and efficacy of a single administration of NRTX-1001 for drug-resistant MTLE. Advancing science and developing novel therapeutics require passionate perseverance, innovative thinking, diverse perspectives, and great teamwork, and we welcome all individuals who want to be part of this exciting journey. The first part of the clinical trial is supported by an $8.0 million grant from the California Institute for Regenerative Medicine (CIRM; CLIN2-13355). MTLE is the most common type of focal epilepsy in adults. Neurona Therapeutics Presents One-Year Data on the First Patient Treated with NRTX-1001 Cell Therapy in an Ongoing Phase I/II Trial for Drug-resistant Focal Epilepsy, April 24, 2023 Syndicate includes premier healthcare investors steeped in neurology, Erica Whittaker, Ph.D., head of UCB Ventures, joins Neuronas board of directors, Latest financing brings total proceeds raised to date to $135 million. Post-administration into preclinical models, RNAseq analysis of single human NRTX-1001 nuclei demonstrated appropriate maturation of the cells into hippocampal/cortical-type interneuron sub-lineages. Furthermore, NRTX-1001 implantation resulted in reduced mesiotemporal sclerosis, or tissue damage in the affected seizure-onset area of the brain. Oppenheimer 33rd Annual Healthcare Conference, Phase I/II NRTX-1001 for epilepsy on clinicaltrials.gov, Visiting Scientists & Internship programs, Neurona Therapeutics Appoints James Stutz as Chief Financial Officer and Chief Business Officer, Neurona Therapeutics Presents One-Year Data on the First Patient Treated with, Neurona Therapeutics Presents Updated Data from the NRTX-1001 Cell Therapy Trial in Adults with Drug-resistant Focal Epilepsy atAmerican Academy of, After 25 Years of Hype, Embryonic Stem Cells are Still Waiting for Their Moment, UC San Diego Health among First in Nation to Perform Regenerative Brain Cell Procedure for Epilepsy, One Shot Epilepsy Treatment Reduced Seizures by 95% in First Two Patients, Oppenheimer 33rd Annual Healthcare Conference. Neurona Therapeutics Receives IND Clearance to Initiate Phase 1/2 SAN FRANCISCO, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing restorative neural cell therapies to treat chronic neurological. Neural cell therapies have the potential to achieve long-lasting disease amelioration for chronic neurological disorders that lack effective treatment options, from a single, one-time dose. NRTX-1001 cells were characterized in functional and single-cell RNAseq assays prior to administration, which confirmed high on-target purity of hippocampal/cortical-type interneurons, so-called GABAergic pallial-type interneurons, that match the specific inhibitory cell lineage affected in the temporal lobe. Neurona Therapeutics Presents Preclinical Data from Lead Cell Therapy Candidate NRTX-1001 at Neuroscience 2021. Neurona Therapeutics Appoints James Stutz as Chief Financial - BioSpace The objective of NRTX-1001 is to add cells that have the potential to repair the circuits that are damaged in epilepsy and thus reduce seizure activity. said Robert Beach, M.D., Ph.D. professor of neurology at SUNY Upstate Medical University. David Blum, M.D., chief medical officer of Neurona, commented, When MTLE originates in the verbal-memory dominant hemisphere, typically the left hemisphere in right-handed individuals, there are risks with the current standard of care, lobectomy surgery, because it puts them at risk of memory impairment post-surgery. These cells are injected into the brain in the area affected by the seizures where they release a neurotransmitter or chemical messenger . Neurona Therapeutics Appoints James Stutz as Chief Financial Officer lwolffe@wheelhouselsa.com, Phase I/II NRTX-1001 for epilepsy on clinicaltrials.gov, Visiting Scientists & Internship programs. Both patients continue to report reduced overall seizure counts of >90% at one year- and seven-months post NRTX-1001 administration, respectively. NRTX-1001 is an injectable suspension of high-purity inhibitory neurons, called interneurons, derived from human stem cells and designed to replace damaged neurons in the region of the brain where seizures originate. Neither subject has experienced a serious adverse event, and the data safety monitoring board has reviewed their progress and allowed the study to continue enrollment. afficher des publicits et des contenus personnaliss en fonction de vos profils de centres dintrt; mesurer lefficacit des publicits et contenus personnaliss; et. The fully-differentiated neural cells, called interneurons, secrete the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Two patients have been treated to date in this clinical trial (NCT05135091), both of whom entered the study with a history of significant monthly seizure activity that was not controlled by anti-seizure medications. Neurona Therapeutics Appoints James Stutz as Chief Financial Officer and Chief Business Officer, June 15, 2023 Neurona Therapeutics to Present at the Piper Sandler 33rd Annual Previously at UCB, she held roles as vice president, research strategy & partnering and head of market access & pricing for the European commercial operations. UCB Ventures invests in innovative therapeutics and technology platforms that are early stage and higher risk, in areas adjacent to or even beyond UCBs therapeutic focus on neurology/neurodegenerative diseases, immunology and muscular skeletal/bone health. For more information, please visit www.clinicaltrials.gov (NCT05135091). Fv-Hsp72 is a powerful targeted cytoprotectant which can directly deliver Hsp72 into stressed and dying cells in . July 31, 2023. Prior to joining UCB, Erica spent 10 years as a top-ranked biotechnology equity analyst for Merrill Lynch in London. We are very excited to take this next step, bringing a first-in-class, novel regenerative treatment to people living with chronic focal seizures. NRTX-1001: Neurona Therapeutics Epilepsy Route of Administration Epilepsy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. The firm's goal: precision small-molecule therapies for a multitude of brain diseases. The first patient, treated at SUNY Upstate Medical University, had a seven-year history of seizures, and in the six months prior to the administration of NRTX-1001 experienced an average of 32 seizures per month. Neurona Therapeutics Raises $41.5M to Advance Neural - GlobeNewswire Patient-one has reached the one-year post treatment endpoint and has achieved a >95% overall monthly seizure reduction, including elimination of all seizure events since the seventh month post-administration of NRTX-1001, said David Blum, M.D., Neuronas chief medical officer. Patient recruitment will soon begin at approximately 10 clinical epilepsy centers across the United States. Neurona Therapeutics Presents Preclinical Data from Lead - GlobeNewswire The first patient had a 9-year history of seizures, and in the six months prior to the administration of NRTX-1001 experienced an average of 32 seizures per month, despite being on several antiepileptic medications. Si vous ne souhaitez pas que nos partenaires et nousmmes utilisions des cookies et vos donnes personnelles pour ces motifs supplmentaires, cliquez sur Refuser tout. For more information, please visit www.clinicaltrials.gov (NCT05135091). Neurona Therapeutics Update: First two patients who received treatment SAN FRANCISCO, June 17, 2022 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, today announced the presentation of investigational new drug (IND)-enabling data that support the companys lead inhibitory neuronal cell therapy candidate, NRTX-1001, which has entered a first-in-human clinical trial for the treatment of drug-resistant focal epilepsy. June 17, 2022 16:55 ET However, current surgical options are not available or effective for all, are tissue-destructive, and can have significant adverse effects. News and Press; Contact; Careers; Menu; United Pharma LLC your softgel solutions partner. The first stage of the trial is an open-label dose-escalation study in up to 10 people with MTLE, with five patients to be treated at a starting dose and five at a higher dose. Latest News and Events for Neurona Therapeutics Company profile page for Neurona Therapeutics Inc including stock price, company news, press releases, executives, board members, and contact information ClearPoint Neuro Congratulates Neurona Therapeutics on Dosing of The fully-differentiated neural cells, called interneurons, secrete the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Neurona Therapeutics Raises $41.5M to Advance Neural Network - BioSpace SAN FRANCISCO, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a biotherapeutics company advancing restorative neural cell therapies for the treatment of chronic neurological disorders . Pig brain cells may have cured a sea lion's epilepsyare humans next? Neurona Therapeutics Raises $41.5M to Advance Neural Network Proceeds from the financing will be used to advance the company's pipeline of wholly . NRTX-1001 is a regenerative neural cell therapy with the potential to repair hyperexcitable neural networks that underlie epilepsy as well as other disorders of the nervous system. Lees ons privacybeleid en cookiebeleid voor meer informatie over hoe we je persoonlijke gegevens gebruiken. Phase I/II NRTX-1001 for epilepsy on clinicaltrials.gov, Visiting Scientists & Internship programs. Neurona Therapeutics Neurona's Competitors, Revenue, Number of Employees, Funding - Owler The first stage of the clinical trial is supported by a recently announced $8.0 million grant from the California Institute for Regenerative Medicine (CIRM) (CLIN2-13355). 7:30 - 8:30 PM PT, Title: HUMAN INHIBITORY NEURON CELL THERAPY ENTERS PHASE I/II CLINICAL INVESTIGATION FOR CHRONIC FOCAL EPILEPSYAuthors: Catherine Priest, Gautam Banik, David Blum, Alessandro Bulfone, Mansi Parekh, Philip Hampel, Hannah Kim, Andrew Adler, Luis Fuentealba, Michael Watson, Seonok Lee, Sonja Kriks, Steven Havlicek, Robin Zhou, Yves Maury, Marina Bershteyn, Cory R. NicholasSession: Stem Cells From Development to TherapyDate: Friday June 17, 2022. Neurona Therapeutics. Relatedly, the NRTX-1001 trial has received clearance from the FDA to expand enrollment to include adults who have MTLE in the verbal memory-dominant lobe and are at greater risk of cognitive decline from a tissue-destructive lobectomy or ablation surgery.

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