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Recently, iRegene announced that the first global innovative product NouvNeu001 has successfully administered to patients at Zhongnan Hospital of Wuhan University. The patient's postoperative condition is good. Director Xiong Nanxiang of the Neurosurgery Department is the leader of this clinical research project at Zhongnan Hospital of Wuhan University. Previously, the three-month sentinel observation period was successfully completed, showing good safety and tolerance, and has been successfully approved to enter the accelerated expansion phase.
On August 2, 2023, the National Medical Products Administration (NMPA) officially approved the Phase I/II clinical study of NouvNeu001 for the safety, tolerability, and efficacy in treating mid-to-late stage Parkinson's disease. This study features a multicenter, open-label design. NouvNeu001 is the world’s first universal cell therapy product based on iPSC and chemically induced technology to enter the new drug registration clinical stage in the field of Parkinson's treatment. The clinical trial was successfully initiated at Beijing Hospital and Zhongnan Hospital of Wuhan University in Q1 2024.In April 2024, iRegene's first globally innovative product, NouvNeu001, successfully completed the 12-week observation period for the first patient and entered the project acceleration phase. Zhongnan Hospital of Wuhan University, as the deputy lead unit of the study, has Professor Xiong Nanxiang from the Department of Neurosurgery serving as the principal investigator. By integrating the advantageous clinical resources of neurosurgery, neurology, and other departments, a systematic evaluation is being conducted on the safety, tolerability, and efficacy of stereotactic bilateral intracerebral injection of NouvNeu001 in treating mid-to-late stage Parkinson's disease. Recently, Zhongnan Hospital of Wuhan University successfully administered the treatment to the first patient at their center, with good postoperative condition.
Dr. Cai Meng, CMO of iRegene, statedThe first patient dosing has been successfully completed at both centers, marking an important milestone in iRegene's development process. This signifies that the project has entered the mature operation phase and reflects iRegene's capability in managing multi-center clinical operations. The successful multi-center operation also indicates that the NouvNeu001 clinical project has entered an accelerated phase.NouvNeu001 Injection, fully independently developed by iRegene (Class I biological product), is a chemically induced human dopaminergic neuron precursor. The product achieves high-purity neuronal subtype reconstruction and functional optimization through chemical induction. After transplantation, it forms connections with the body's original neurons, enhances cellular secretion functions, and further strengthens the improvement of the original lesion by the transplanted cells, achieving comprehensive therapeutic effects.Based on the high professionalism of the iRegene team and the participating institutions in this clinical trial, as well as their responsible attitude towards the well-being of the vast number of Parkinson's disease patients, the iRegene team has collaborated closely with Beijing Hospital and Zhongnan Hospital of Wuhan University to bring a new treatment option to Parkinson's patients across China.
Source: iRegene
