SAN FRANCISCO, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a biotherapeutics company advancing restorative neural cell therapies for the treatment of chronic neurological disorders, today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a first-in-human Phase 1/2 clinical trial to evaluate the safety and efficacy of NRTX-1001 in people with drug-resistant mesial temporal lobe epilepsy (MTLE). Her deep industry experience in and out of the epilepsy arena will be invaluable to Neurona as we further develop our unique neural cell therapy platform, said Cory Nicholas, Ph.D., Neuronas president and chief executive officer. In October 2020, the patienta seven-year-old sea lion named Cronuttunderwent an experimental brain surgery that involved transplanting healthy pig neurons into his damaged hippocampus. Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, today announced the first patient dosed in a Phase 1/2 clinical trial of its lead program, NRTX-1001, in a first-in-human epilepsy study.An estimated three million Americans have epilepsy, and 25 to 35 percent live with ongoing seizures despite . With additional data from the full cohort, we will determine how to most efficiently advance this novel regenerative cell therapy with the potential to transform the lives of patients for whom anti-seizure medication has failed.. 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. NRTX-1001: Neurona Therapeutics Epilepsy Route of Administration Epilepsy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Wheelhouse LSA We are proud of the continued commitment of our current investors and the confidence placed in us by new investors. NRTX-1001 is a neuronal cell therapeutic derived from human pluripotent stem cells using Neuronas proprietary manufacturing process. We are delighted to work with the Neurona team to evaluate the potential of this exciting new therapeutic approach.. In addition, with the DSMBs clearance to continue the study, we are working with major epilepsy centers across the U.S. to enroll the remaining patients into the first cohort of the NRTX-1001 trial, said Cory R. Nicholas, Ph.D., Neuronas chief executive officer. 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. Neurona Therapeutics Raises $41.5M to Advance Neural Network - BioSpace Neurona's Competitors, Revenue, Number of Employees, Funding - Owler The pipeline includes neuronal, glial, and gene-edited cell therapy candidates led by NRTX-1001, a first-in-class inhibitory neuron therapy for epilepsy. Data presented by Marina Bershteyn, Ph.D., who co-directs Neuronas discovery research department, describe the characterization of NRTX-1001, a cell therapeutic produced from human pluripotent stem cells using Neuronas proprietary process in the companys in-house manufacturing facility. Patients treated with a single infusion of NRTX-1001 cells will be monitored for safety, tolerability, and effects on their epilepsy disease symptoms. The first stage of the trial is an open-label dose-escalation study in up to 10 people with MTLE. Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, today announced the presentation of a clinical case study from the initial dose cohort of the Phase 1/2 first-in-human epilepsy clinical trial of its lead program, NRTX-1001. 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). Industry, government and academic . Neurona Therapeutics Appoints James Stutz as Chief Financial Officer and Chief Business Officer, June 15, 2023 Neuronas multicenter, Phase 1/2 clinical trial is designed to evaluate the safety and efficacy of a single administration of NRTX-1001 for drug-resistant MTLE. About MTLE MTLE primarily affects the internal structures of the temporal lobe, where seizures often begin in a structure called the hippocampus. Patient recruitment is underway at epilepsy centers across the United States. NRTX-1001 is a new type of inhibitory cell therapy that is targeted to the focal seizure onset region in the brain and, in a single treatment, has the potential to significantly improve the lives of people living with focal epilepsy., To our knowledge, NRTX-1001 is the first human cell therapy candidate to enter clinical trials for epilepsy, said David Blum, M.D., head of clinical development at Neurona Therapeutics. Neurona is initially focused on developing NRTX-1001 as a restorative treatment for mesial temporal lobe epilepsy (MTLE). Details of the presentations are as follows: Title: RAPID DETECTION OF PALLIAL GABAERGIC INTERNEURON SUBTYPES BY SINGLE NUCLEI RNA SEQUENCING AFTER PRECLINICAL TRANSPLANTATION OF NRTX-1001, A CELLULAR THERAPEUTIC IN CLINICAL DEVELOPMENT FOR EPILEPSYAuthors: Marina Bershteyn, Robin Zhou, Luis Fuentealba, Geetha Subramanyam, Meliz Sezan, Daniel Cherkowsky, Adrian Bates, Steven Havlicek, Yves Maury, Alessandro Bulfone, Gautam Banik, Catherine Priest, Cory R. NicholasPoster #: 124Date: Wednesday June 15, 2022. Supported by these promising data, Neurona is initiating a first ever clinical trial of human cell therapy for epilepsy. The first two patients to receive NRTX-1001 in the ongoing clinical trial (NCT05135091), both entered the study with a history of significant monthly seizure activity that was not controlled by anti-seizure medications. MTLE is the most common type of focal epilepsy in adults. 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. 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). Vous pouvez modifier vos choix tout moment en cliquant sur les liens Paramtres de confidentialit et des cookies ou Tableau de bord sur la confidentialit prsents sur nos sites et dans nos applications. This promising program is the result of many years of work, dedication, and innovation by the Neurona team and its collaborators as well as key funding secured by grants received from the California Institute for Regenerative Medicine. April 24, 2023. Patients treated with a single infusion of NRTX-1001 cells will be monitored for safety, tolerability, neural cell viability, and effects on their epilepsy disease symptoms. 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. Visit www.UCBVentures.com, Sylvia Wheeler Other new investors included Sphera Fund Management, Alexandria Venture Investments, and Ironfire Ventures. Neurona Therapeutics Raises $41.5M to Advance Neural Network Neurona Therapeutics | LinkedIn NRTX-1001 comprises interneurons that secrete the inhibitory neurotransmitter, gamma-aminobutyric acid (GABA). United Pharma LLC We continue to enroll patients in the first cohort of the study and look forward to providing additional updates later this year., Both patients entered the clinical trial with significant seizure activity, impaired cognition, and suboptimal quality of life, said Cory R. Nicholas, Ph.D., Neuronas chief executive officer who gave one of the presentations at the meeting. NRTX-1001 is an investigational candidate and is being evaluated in ongoing clinical trials. SAN FRANCISCO, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a biotherapeutics company advancing restorative neural cell therapies to treat chronic neurological disorders, today announced three presentations of supporting preclinical data for its lead clinical candidate, NRTX-1001, an inhibitory neuronal cell therapy. They were candidates for lobectomy or ablation surgery to remove the epileptic seizure-generating temporal lobe, albeit with an associated risk of causing further, irreversible cognitive deficits. Nous, Yahoo, faisons partie de la famille de marques Yahoo. MTLE primarily affects the internal structures of the temporal lobe, where seizures often begin in a structure called the hippocampus. 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. San Francisco, CA, June 15, 2023 Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, announced the presentation of new data from the open-label, single arm, starting dose-level of its ongoing Phase I/II clinical trial of a one-time dose of NRTX-1001 in people with drug-resistant mesial temporal lobe epilepsy (MTLE). Patients treated with a single infusion of NRTX-1001 cells will be monitored for safety, tolerability, and effects on their epilepsy disease symptoms. Supported by compelling preclinical data, Neurona has opened a clinical trial to evaluate NRTX-1001 in adults with mesial temporal lobe epilepsy (MTLE), said Cory R. Nicholas, Ph.D., Neuronas president and chief executive officer. SAN FRANCISCO, June 15, 2023 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological. Neurona also announced that Erica Whittaker, Ph.D., head of UCB Ventures, has joined Neuronas board of directors. Nous, Yahoo, faisons partie de la famille de marques Yahoo. An estimated three million Americans have epilepsy, and 25 to 35 percent live with ongoing seizures despite dozens of approved drugs on the market, which means that there is a huge unmet medical need in this community. Neurona Therapeutics Presents Preclinical Data from Lead - GlobeNewswire These preliminary clinical observations, as well as supporting preclinical data, are being presented at the Annual Meeting of the International Society for Stem Cell Research (ISSCR) which is being held June 14 - 17 in Boston, MA and virtually. SAN FRANCISCO, June 22, 2021 (GLOBE NEWSWIRE) -- Neurona Therapeutics Inc., a biotherapeutics company developing neural cell therapies for the treatment of chronic neurological disorders, today announced the successful completion of a $41.5 million financing. For people with seizures resistant to anti-seizure drugs, epilepsy surgery - where the damaged temporal lobe is surgically removed or ablated by laser - can be an option. INFLAMMATION. NRTX-1001 is manufactured in Neuronas in-house GMP facility, using proprietary methods to guide the cells into a specific, pallial-type, lineage of interneurons that secrete the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Als u niet wilt dat wij en onze partners cookies en persoonsgegevens voor deze aanvullende doeleinden gebruiken, klik dan op 'Alles weigeren'. The clearance of our first IND is a key milestone for Neurona and a testament to the talent, experience, and hard work of the entire Neurona team, said Cory Nicholas, Ph.D., Neuronas president and chief executive officer. Dcouvrez comment nous utilisons vos donnes personnelles dans notre Politique de confidentialit et notre Politique relative aux cookies. 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. Neumora launches with $500 million to develop drugs for brain diseases Proceeds from the financing will be used to advance the company's pipeline of wholly . Delivered as a one-time dose, the human interneurons integrate and innervate on-target, providing long-term GABAergic inhibition to repair hyperexcitable neural networks that underlie epilepsy as well as other disorders of the nervous system. For more information, please visit www.clinicaltrials.gov (NCT05135091). For people resistant to anti-seizure drugs, epilepsy surgery, where the damaged temporal lobe is surgically removed or ablated by laser, can be an option. 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. These cells are injected into the brain in the area affected by the seizures where they release a neurotransmitter or chemical messenger . Neurona cites difficult funding environment for staff cuts - Fierce Biotech July 31, 2023 Lees ons privacybeleid en cookiebeleid voor meer informatie over hoe we je persoonlijke gegevens gebruiken. 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 | NRTX-1001 Inhibitory Neuron Cell Therapy Promising reduction (>95%) in seizure frequency at the key one-year post treatment endpoint in the first patient to receive NRTX-1001, memory improvements, and seizure-freedom since seven-months . 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. swheeler@wheelhouselsa.com, Elizabeth Wolffe, Ph.D. About us. 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. Cell therapy biotech Neurona has laid off a quarter of its staff, or 18 of 68 employees, a spokesperson confirmed with Fierce Biotech. Dcouvrez comment nous utilisons vos donnes personnelles dans notre Politique de confidentialit et notre Politique relative aux cookies. SAN FRANCISCO, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing restorative neural cell therapies to treat chronic neurological. 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. afficher des publicits et des contenus personnaliss en fonction de vos profils de centres dintrt; mesurer lefficacit des publicits et contenus personnaliss; et. Catherine Priest | LinkedIn Neurona Therapeutics Neurona is initially advancing NRTX-1001 for temporal lobe epilepsy, which is the most common type of focal epilepsy. Delivered as a one-time administration, the interneurons integrate and innervate on-target, providing local long-term GABAergic inhibition to rebalance and repair hyperexcitable neural networks that underlie epilepsy as well as other disorders of the nervous system. 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. Both patients have reported reduced seizure counts by >90% at six- and three-months post NRTX-1001 administration, respectively. 1:55 2:05 PM PT. Fv-Hsp72 is a powerful targeted cytoprotectant which can directly deliver Hsp72 into stressed and dying cells in . Neurona Therapeutics Appoints James Stutz as Chief Financial Officer and Chief Business Officer. The first part of the clinical trial is supported by a recently announced $8.0 million grant from the California Institute for Regenerative Medicine (CIRM; CLIN2-13355). San Francisco, CA, June 22, 2021 - Neurona Therapeutics Inc., a biotherapeutics company developing neural cell therapies for the treatment of chronic neurological disorders, today announced the successful completion of a $41.5 million financing. About NRTX-1001NRTX-1001 is an inhibitory nerve cell therapy derived from human pluripotent stem cells. SOLANA BEACH, Calif., June 29, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain today congratulates partner Neurona Therapeutics on dosing the first patient in their Phase 1/2 clinical trial of its lead program NRTX-1001, in a. Epilepsy is one of the most common neurological disorders, affecting over three million people in the U.S. of whom approximately one-third have drug-resistant disease. For more information about Neurona, visit www.neuronatherapeutics.com, UCB Ventures is a 150 million strategic corporate venture fund established in 2017 to further strengthen UCBs ability to create value from novel insights and technologies that can transform the lives of patients suffering from severe diseases. Rubicon's mission is to develop novel, practical targeted therapies that will greatly benefit the patient. Proceeds from the financing will be used to advance the companys pipeline of wholly-owned, off-the-shelf cell therapies for multiple indications, including a Phase 1/2a clinical study planned to launch later this year for its lead product, NRTX-1001, an inhibitory neuronal cell therapeutic, for the treatment of chronic focal epilepsy. Neurona Therapeutics Presents One-Year Data on the First - Benzinga Company profile page for Neurona Therapeutics Inc including stock price, company news, press releases, executives, board members, and contact information Neurona TherapeuticsInvestor and Media Contacts: Sylvia WheelerWheelhouse LSAswheeler@wheelhouselsa.com, Elizabeth Wolffe, Ph.D.Wheelhouse LSAlwolffe@wheelhouselsa.com, Inside KCON LA 2023, an extravagant microcosm of K-pop's macro influence, Oil Holds Loss on Signs of Supply Rebound as Demand Woes Linger, BRICS leaders meet in South Africa as bloc weighs expansion, Dubai International Airport sees 41.6 million passengers in first half of year, more than in 2019, Indonesia, Boeing sign deal for sale of F-15 fighter jets. For more information about Neurona, visitwww.neuronatherapeutics.com, Sylvia Wheeler 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. A dose-finding study in the MTLE model identified a broad maximum effective dosing range and no detectable dose-limiting toxicities. The fully-differentiated neural cells, called interneurons, secrete the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Wheelhouse LSA Neurona Therapeutics Inc - Company Profile and News 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 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. In addition, neuropsychological testing suggests an improvement in memory after NRTX-1001 administration. In this way, neural cell therapies can becurative. Neurona Therapeutics Presents Preclinical Data from Lead Cell Therapy Candidate NRTX-1001 at Neuroscience 2021. San Francisco, CA, June 29, 2022 - Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, today announced the first patient dosed in a Phase 1/2 clinical trial of its lead program, NRTX-1001, in a first-in-human epilepsy study. 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. Wanneer u onze sites en apps gebruikt, gebruiken we, gebruikers authenticeren, veiligheidsmaatregelen toepassen en spam en misbruik voorkomen, en, gepersonaliseerde advertenties en content weergeven op basis van interesseprofielen, de effectiviteit meten van gepersonaliseerde advertenties en content, en, onze producten en services ontwikkelen en verbeteren. About Us; What We Do; Why United Pharma; Our Team; News and Press; Contact; Careers; Fullerton, CA 92833 Tel (714) 738-8999 Fax (714) 738-8988 ClearPoint Neuro Congratulates Neurona Therapeutics on Dosing of Beckman Coulter and Fujirebio Partner to Bolster Access to Patient-friendly, Blood-based Alzheimer's Disease Test Therapeutics BREA, Calif. & TOKYO--(BUSINESS WIRE)-- #IVD--Beckman Coulter Diagnostics, a clinical diagnostics leader, and Fujirebio, a leader in neurological markers and In Vitro Diagnostic (IVD) manufacturing, today announced a new partnership combining their respective . Neuronas regenerative cell therapies have single-dose curative potential. Neurona Therapeutics Announces Initial Subject Dosed in First Clinical Neurona Therapeutics Presents Updated Data from the NRTX - BioSpace She has a Ph.D. in molecular biology and an MBA. SAN FRANCISCO, Feb. 14, 2023 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological. Je kunt je keuzes te allen tijde wijzigen door te klikken op de links 'Privacy- en cookie-instellingen' of 'Privacydashboard' op onze sites en in onze apps. Experienced leader with a broad background in the fields of neuroscience, stem cell biology and preclinical development of cell-based therapeutics. Wheelhouse LSA Working at Neurona Therapeutics | Glassdoor NRTX-1001 is a regenerative neural cell therapy delivered as a single dose and designed to provide long-term secretion of gamma-aminobutyric acid (GABA), a key inhibitory neurotransmitter, to repair hyper-excitable neural networks associated with mesial temporal lobe epilepsy (MTLE), the most common form of focal epilepsy in adults.

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