Neurona Therapeutics Receives IND Clearance to Initiate Phase 1/2 Clinical Trial of Neural Cell Therapy NRTX-1001 in Chronic Focal Epilepsy Patients
Excerpt from the Press Release:
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). 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.
“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., Neurona’s president and chief executive officer. “This milestone is especially rewarding and timely given that November is Epilepsy Awareness Month. 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. 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. “Unlike many other interventions for drug-resistant focal epilepsy, including surgical removal or ablation of brain tissue, NRTX-1001 has the potential to achieve seizure freedom in a non-tissue destructive manner.”
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