Sarcocystis neurona

Neurona Therapeutics Announces Participation in Upcoming Investor Conferences in October

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Tuesday, October 10, 2023
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The presentation will be webcast live and may be accessed via a link in the News section of the Neurona website under Events .

Key Points: 
  • The presentation will be webcast live and may be accessed via a link in the News section of the Neurona website under Events .
  • An archived copy of the webcast will be available on the website for approximately 30 days after the event.
  • Dr. Nicholas has also been invited to participate in a panel discussion titled: Fighting Neurodegeneration​ with New Tools, at 1:00 pm PT on Wednesday, October 18, 2023 at the BIO Investor Forum which is being held October 17-18, 2023 in San Francisco.
  • Webcasting is not available for this event.

Neurona Therapeutics Announces Publication in Cell Stem Cell Reporting the Development of Investigational Novel Regenerative Cell Therapy Strategy for Drug-resistant Focal Epilepsy

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Thursday, October 5, 2023
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SAN FRANCISCO, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapy candidates for the treatment of neurological disorders, today announced the publication of the development and characterization of a highly purified population of human stem cell-derived, pallial-specific MGE inhibitory interneurons for the potential treatment of focal epilepsy. In a preclinical study, administration of a single dose of the cells in a chronic model of drug-resistant MTLE resulted in durable and consistent suppression of focal seizures, as well as improvements in neuropathology and an increase in survival of the model. The study also demonstrated a potentially broad, safe and effective dosing range in the preclinical model. The data support the development of Neurona Therapeutics’ regenerative cell therapy candidate, NRTX-1001, which is being evaluated in an ongoing Phase I/II clinical trial of a one-time dose in subjects with drug-resistant MTLE (NCT05135091). The preclinical data were published today in Cell Stem Cell as a Clinical and Translational Report titled “Human pallial MGE-type GABAergic interneuron cell therapy for chronic focal epilepsy” by first authors Bershteyn, Bröer, Parekh, Maury, and colleagues and is available online.

Key Points: 
  • The data support the development of Neurona Therapeutics’ regenerative cell therapy candidate, NRTX-1001, which is being evaluated in an ongoing Phase I/II clinical trial of a one-time dose in subjects with drug-resistant MTLE ( NCT05135091 ).
  • The preclinical data were published today in Cell Stem Cell as a Clinical and Translational Report titled “Human pallial MGE-type GABAergic interneuron cell therapy for chronic focal epilepsy” by first authors Bershteyn, Bröer, Parekh, Maury, and colleagues and is available online .
  • “We are thrilled to announce this landmark publication, which builds the foundation for NRTX-1001 and exemplifies the phenomenal science being conducted by Neurona employees.
  • The data support the development of Neurona’s cell therapy candidate NRTX-1001, which is being evaluated in an ongoing clinical trial ( NCT05135091 ) in adults with drug-resistant MTLE.

Neurona Therapeutics Appoints James Stutz as Chief Financial Officer and Chief Business Officer

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Monday, July 31, 2023
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SAN FRANCISCO, July 31, 2023 (GLOBE NEWSWIRE) -- Neurona Therapeutics , a clinical-stage biotherapeutics company advancing regenerative cell therapy candidates for the treatment of neurological disorders, today announced the appointment of James Stutz, a business and finance executive with over 20 years of experience in the biopharma industry, as chief financial officer (CFO) and chief business officer (CBO).

Key Points: 
  • SAN FRANCISCO, July 31, 2023 (GLOBE NEWSWIRE) -- Neurona Therapeutics , a clinical-stage biotherapeutics company advancing regenerative cell therapy candidates for the treatment of neurological disorders, today announced the appointment of James Stutz, a business and finance executive with over 20 years of experience in the biopharma industry, as chief financial officer (CFO) and chief business officer (CBO).
  • Before joining Instil Bio, Mr. Stutz was the CFO at Tolerion, and CBO at Tioma Therapeutics.
  • Mr. Stutz earned an MBA from the Tuck School of Business at Dartmouth and a B.A.
  • in business economics, from the University of California at Santa Barbara.

Neurona Therapeutics Announces Presentation at the Oppenheimer 33rd Annual Healthcare Conference

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Wednesday, March 8, 2023
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SAN FRANCISCO, March 08, 2023 (GLOBE NEWSWIRE) -- Neurona Therapeutics , a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, announced that Cory R. Nicholas, Ph.D., Neurona’s chief executive officer, will provide a corporate update at the Oppenheimer 33rd Annual Healthcare Conference on Wednesday, March 15 at 2:00 pm ET.

Key Points: 
  • SAN FRANCISCO, March 08, 2023 (GLOBE NEWSWIRE) -- Neurona Therapeutics , a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, announced that Cory R. Nicholas, Ph.D., Neurona’s chief executive officer, will provide a corporate update at the Oppenheimer 33rd Annual Healthcare Conference on Wednesday, March 15 at 2:00 pm ET.
  • The presentation will be webcast live and may be accessed via a link in the News section of the Neurona website under Events .
  • An archived copy of the webcast will be available on the website for approximately 30 days after the event.

Neurona Therapeutics Announces FDA Clearance of Expanded Inclusion Criteria for Phase I/II Clinical Trial of NRTX-1001 Regenerative Cell Therapy in Patients with Dominant Hemisphere Drug-Resistant Focal Epilepsy

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Tuesday, February 14, 2023
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SAN FRANCISCO, Feb. 14, 2023 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, announced that the U.S. Food and Drug Administration (FDA) has cleared an amendment to Neurona’s ongoing Phase I/II clinical trial of NRTX-1001 in people with drug-resistant mesial temporal lobe epilepsy (MTLE) enabling expansion of enrollment to include adults who have dominant-lobe disease, as well as those whose disease is focused in the non-dominant lobe. In addition, the independent Data and Safety Monitoring Board (DSMB) overseeing the clinical trial completed a prespecified review of data from the first two patients and unanimously recommended progression of the trial to enroll the remaining patients in the first dose cohort.

Key Points: 
  • “We remain cautiously optimistic that the early signs of safety and potential efficacy will continue for our existing and future patients.
  • The second patient treated in the trial also had drug-resistant seizures, with an average of 14 seizures per month in the six months prior to treatment.
  • Both patients have reported reduced seizure counts by >90% at six- and three-months post NRTX-1001 administration, respectively.
  • NRTX-1001 interneurons are cryopreserved and shipped to clinical sites to be used as an allogeneic, off-the-shelf investigative therapy.

Neurona Therapeutics Presents Clinical Data for NRTX-1001 Regenerative Cell Therapy for Drug-Resistant Focal Epilepsy at American Epilepsy Society Annual Meeting

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Monday, December 5, 2022
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SAN FRANCISCO, Dec. 05, 2022 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, announced the presentation of clinical data from Neurona’s ongoing Phase I/II clinical trial of NRTX-1001 in people with mesial temporal lobe epilepsy (MTLE) as well as supporting preclinical and manufacturing data at the annual meeting of the American Epilepsy Society. The meeting is being held in Nashville, TN, December 2-6, 2022.

Key Points: 
  • In a poster entitled: NRTX-1001: First-in-class human inhibitory neuron cell therapy for phase I/II clinical investigation in chronic focal epilepsy, data were provided demonstrating the characterization, delivery, and initial clinical trial progress from the first patients treated in the groundbreaking clinical trial ( NCT05135091 ).
  • NRTX-1001 is a regenerative cell therapeutic with the potential to durably eliminate seizures after a single administration.
  • NRTX-1001 interneurons are cryopreserved and shipped to clinical sites to be used as an allogeneic, off-the-shelf investigative therapy.
  • Neurona is developing off-the-shelf, allogeneic neuronal, glial, and gene-edited cell therapy candidates that are designed to provide long-term repair of dysfunctional neural networks for multiple neurological disorders.

Neurona Therapeutics Presents Encouraging Clinical Data from First-Ever Regenerative Human Cell Therapy Trial in Adults with Drug-Resistant Focal Epilepsy and Shows Supporting Manufacturing, Delivery, and Preclinical Data

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Monday, November 21, 2022
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SAN FRANCISCO, Nov. 21, 2022 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, announced that Cory R. Nicholas, Ph.D., Neurona’s president and chief executive officer, was invited to present an overview of Neurona’s regenerative cell therapy technology, proprietary manufacturing process, cell delivery system, and preclinical data supporting its ongoing Phase I/II clinical trial of NRTX-1001 in people with focal epilepsy at the recent ISSCR Boston International Symposium: Translating Pluripotent Stem Cell Discoveries to the Clinic: Preclinical, Manufacturing, and Regulatory Strategies for Success. In his presentation on Saturday, November 19, 2022, Dr. Nicholas also provided an update on the first two patients treated in the groundbreaking 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. Following treatment with NRTX-1001, both patients have thus far seen encouraging signs of seizure reduction.

Key Points: 
  • The early clinical results with NRTX-1001 in epilepsy are very encouraging, and we look forward to enrolling additional patients in the study, said Dr. Nicholas.
  • Further, there are many who are not currently eligible for lobectomy surgery who may be eligible for NRTX-1001 in the future.
  • NRTX-1001 interneurons are cryopreserved and shipped to clinical sites to be used as an allogeneic, off-the-shelf investigative therapy.
  • In addition to the preclinical efficacy and NRTX-1001 characterization data supporting the clinical program, the presentation highlighted data from the first two adult patients with mesial temporal lobe epilepsy (MTLE) treated in Neuronas clinical trial.

Neurona Therapeutics Presents Clinical Case Study from First Human Trial of Regenerative Cell Therapy, NRTX-1001, in Adults with Drug-Resistant Focal Epilepsy

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Wednesday, September 21, 2022
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SAN FRANCISCO, Sept. 21, 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 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 data from three months post-cell therapy administration to the first patient in this study show that there were no serious adverse events associated with NRTX-1001 treatment and that the patient has thus far experienced reduced seizure frequency from an average prior history of 30+ seizures per month to four seizures in total during three months of follow-up to date. The data are being presented by Catherine Priest, Ph.D., Neurona’s chief development officer at the ISSCR-ASGCT Conference: Emerging Therapies at the Intersection of Genetic and Cellular Technologies being held in Madison, WI, September 21 -23, 2022.

Key Points: 
  • We are very grateful to these first participants, and thank the clinical teams for the careful execution of this pioneering study.
  • The patient is a young adult male with a 9-year history of seizures and was diagnosed with unilateral mesial temporal lobe epilepsy (MTLE).
  • The clinical trial is funded in part by the California Institute for Regenerative Medicine (DISC2-10525; TRAN1-11611; CLIN2-13355).
  • 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).

ClearPoint Neuro Congratulates Neurona Therapeutics on Dosing of Initial Subject in First Clinical Trial of Regenerative Human Cell Therapy in Adults with Drug-Resistant Focal Epilepsy

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Wednesday, June 29, 2022
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An estimated three million Americans have epilepsy, and 25 to 35 percent live with ongoing seizures despite dozens of approved drugs on the market.

Key Points: 
  • An estimated three million Americans have epilepsy, and 25 to 35 percent live with ongoing seizures despite dozens of approved drugs on the market.
  • The first stage of the trial is an open-label dose-escalation study in up to 10 patients with MTLE.
  • Our team is proud to partner with Neurona to support their Phase 1/2 clinical trial of what could potentially be a breakthrough regenerative cell therapy for MTLE.
  • ClearPoint Neuro is partnered with approximately 45 biologics/pharmaceutical companies and academic centers, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide.

Neurona Therapeutics Announces Initial Subject Dosed in First Clinical Trial of Regenerative Human Cell Therapy, NRTX-1001, in Adults with Drug-Resistant Focal Epilepsy

Retrieved on: 
Wednesday, June 29, 2022
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SAN FRANCISCO, June 29, 2022 (GLOBE NEWSWIRE) -- 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 dozens of approved drugs on the market, which means that there is a huge unmet medical need in this community. 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.

Key Points: 
  • We are very excited to take this next step, bringing a first-in-class, novel regenerative treatment to people living with chronic focal seizures.
  • We are delighted to work with the Neurona team to evaluate the potential of this exciting new therapeutic approach.
  • 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.
  • 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).