Neurona Therapeutics Presents Clinical Case Study from First Human Trial of Regenerative Cell Therapy, NRTX-1001, in Adults with Drug-Resistant Focal Epilepsy
Clinical assessments three-months post-treatment report no serious adverse events and reduced seizure frequency to date in first trial participant
Data Safety Monitoring Board clears advancement of trial to continue enrollment
Pioneering cell therapy approach could provide a disease-modifying treatment for drug-resistant focal epilepsy
Data presented at ISSCR-ASGCT Conference: Emerging Therapies at the Intersection of Genetic and Cellular Technologies
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.
“The reduced number of seizures reported by the first person to receive NRTX-1001 is very encouraging, and we remain cautiously optimistic that this reduction in seizure frequency will continue and extend to others entering this cell therapy trial. NRTX-1001 administration has been well tolerated thus far in the clinic, which is in line with the extensive preclinical safety data collected by the Neurona team,” said Cory R. Nicholas, Ph.D. Neurona’s president and chief executive officer. “With recent clearance from the Data Safety Monitoring Board we are excited to continue patient enrollment. We are very grateful to these first participants, and thank the clinical teams for the careful execution of this pioneering study.
In addition to the preclinical data supporting the clinical program, the presentation highlights initial data from the first patient treated in Neurona’s clinical trial who received a starting dose of NRTX-1001. The patient is a young adult male with a 9-year history of seizures and was diagnosed with unilateral mesial temporal lobe epilepsy (MTLE). In the six months prior to the administration of NRTX-1001, the patient experienced an average of 32 seizures per month, despite being on several antiepileptic medications. The patient received NRTX-1001, and the treatment was well tolerated; there have been no serious adverse events to date. The patient has reported having four seizures during the first three months since receiving NRTX-1001.
The clinical trial is funded in part by the California Institute for Regenerative Medicine (DISC2-10525; TRAN1-11611; CLIN2-13355).
About Neurona’s Clinical Trial of NRTX-1001 for Mesial Temporal Lobe Epilepsy (MTLE)
About Mesial Temporal Lobe Epilepsy (MTLE)
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