iRegene's therapy available via single-patient EA is the NouvNeu001 for the indication of Parkinson's Disease.
iRegene Therapeutics （“iRegene”）is a biopharmaceutical company dedicated to innovative chemical induction platforms, developing new generation of chemical-induced cell therapy products targeted therapies for neurodegenerative diseases, metabolic system diseases, genetic diseases and so on. We conduct clinical trials to evaluate the safety and efficacy of its investigational products (NouvNeu001) in support of regulatory approvals by the U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA) and other regulatory authorities, with the goal of making these therapies widely accessible to patients with unmet medical needs. In the meantime, iRegene is also happy to provide available therapies via Single-Patient Expanded access (EA) for the treatment of Parkinson’s disease with their cell product NouvNeu001.
EA is designed to provide access to investigational therapy prior to registration by the applicable local regulatory agency. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient’s medical history and program eligibility criteria. EA will be available for indications where there is reasonable scientific basis for use, and availability will depend on territory eligibility. iRegene will review requests for EA to its investigational medicines according to the following criteria:
• The patient’s disease is serious or life-threatening.
• The patient has undergone appropriate standard treatments; there are no comparable or satisfactory alternative treatments for the disease or condition; the treatment is adjunct to an existing treatment option, and the treatment is not medically contraindicated.
• Sufficient efficacy and safety evidence exists to make a benefit-risk analysis consistent with this policy and the potential patient benefit justifies any potential risks of treatment. (Such conditions are usually met at the end of Phase 1b studies, and depending on the clinical program, potentially even later.)
• Sufficient clinical data are available to identify an appropriate dose and treatment duration.
• The patient’s treating physician and qualified medical personnel at iRegene agree there is sufficient evidence to assume the potential benefit to the patient justifies potential risks.
• The patient is not eligible for participation in an ongoing clinical trial of the investigational medicine, including but not limited to lack of access due to geographic limitations.
• EA will not adversely impact any clinical development program, in particular, the conduct of a pivotal clinical trial that is required for regulatory approval.
• The request must be made by the patient’s treating physician, who must be a qualified and licensed MD, unsolicited by iRegene or any other individual or organization working on behalf of iRegene.
If all these conditions are met, iRegene will consider EA requests from treating physicians.