NouvNeu001 Hits Milestone with Successful Dosing of First Patient in iRegene Therapeutics' Multicenter Clinical Trial for Novel Parkinson's Disease Therapy
iRegene Therapeutics Co., Ltd (iRegene) recently made an important announcement regarding the progress of NouvNeu001, their innovative product. They reported the completion of dosing for the first patient at Beijing Hospital, marking the successful conclusion of the observation period.
This achievement is part of a Phase I/II clinical trial designed to evaluate NouvNeu001's safety, tolerability, and efficacy in treating moderate to advanced Parkinson's disease. The trial has begun at both Beijing Hospital and Zhongnan Hospital, with the first patient completing dosing.
Dr. Cai, iRegene's Chief Medical Officer, highlighted the significance of this milestone in the company's development.
NouvNeu001 is a chemically induced human dopaminergic neuron precursor derived from iPSC, wholly owned by iRegene. It is the world's first iPSC-based and chemically induced universal cell therapy product. NouvNeu001 is designed to optimize neuronal subtypes through chemical induction, establishing connections with existing neurons upon transplantation to enhance cellular secretion functions and address the original lesion, offering comprehensive therapeutic effects.
The National Medical Products Administration (NMPA) of China approved the Phase I/II clinical trial of NouvNeu001 on August 2, 2023. The trial, aimed at evaluating safety, tolerability, and efficacy in treating moderate to advanced Parkinson's disease, commenced successfully at Beijing Hospital in early January 2024. More details about the trial can be found on clinicaltrials.gov (NCT#06167681).
iRegene Therapeutics is a pioneering biotech company focused on utilizing "AI + chemical induction" for cell-specific functional remodeling. Leveraging this platform, iRegene has developed a robust pipeline of universal iPSC-derived products. The company is dedicated to advancing universal cell therapy products and introducing novel treatment options for traditionally challenging neurodegenerative diseases such as Parkinson's disease and blindness.
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