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资讯
NLS Pharmaceutics和Kadimastem宣布由Kadimastem和iTolerance, Inc.提交申请，就一种创新性突破性1型糖尿病治疗向FDA提出预先IND会议申请
12月19日星期四上午7:30
• 这一提交是在今年早些时候与FDA成功举行INTERACt会议后进行的。
• NLS制药和Kadimastem计划在2025年1月底完成合并。
苏黎世，瑞士和内斯锡翁，以色列 / ACCESSWIRE / 2024年12月19日 / NLS制药有限公司（纳斯达克：NLSP）和 卡迪玛斯泰姆有限公司（"Kadimastem"），一家专门从事神经退行性疾病和糖尿病“现成”同种异体细胞疗法产品的临床阶段公司，今天宣布与迈阿密再生医学公司iTolerance Inc.（"iTolerance"）合作，Kadimastem和iTolerance已向美国食品和药物管理局（"FDA"）提交了预申请新药（"Pre-IND"）会议的请求。 美国食品和药物管理局（"FDA"） for iTOL102, an investigational biologic consisting of allogenic human stem cell-derived pancreatic islets combined with an immunomodulator for the treatment of Type 1 Diabetes. Kadimastem believes that this collaboration signifies a potentially transformative step in diabetes treatment.
This submission comes after a successful INTERACt ("Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products") meeting, which is a meeting at a specific time early in the product development, between Kadimastem, iTolerance, and the FDA earlier this year. The submission is a significant milestone toward the clinical development of iTOL102, an on-going collaborative research initiative between iTolerance and Kadimastem, funded in part by the Israel-United States Binational Industrial Research and Development Foundation ("BIRD"). iTOL102 combines iTolerance's proprietary SA-FasL microgel (known as iTOL-100), an immune modulator, and IsletRx, insulin-producing islet cells derived from human pluripotent stem cells, to generate an innovative treatment intended for the potential cure of type 1 diabetes.
12月19日星期四上午7:30
• 这一提交是在今年早些时候与FDA成功举行INTERACt会议后进行的。
• NLS制药和Kadimastem计划在2025年1月底完成合并。
苏黎世，瑞士和内斯锡翁，以色列 / ACCESSWIRE / 2024年12月19日 / NLS制药有限公司（纳斯达克：NLSP）和 卡迪玛斯泰姆有限公司（"Kadimastem"），一家专门从事神经退行性疾病和糖尿病“现成”同种异体细胞疗法产品的临床阶段公司，今天宣布与迈阿密再生医学公司iTolerance Inc.（"iTolerance"）合作，Kadimastem和iTolerance已向美国食品和药物管理局（"FDA"）提交了预申请新药（"Pre-IND"）会议的请求。 美国食品和药物管理局（"FDA"） for iTOL102, an investigational biologic consisting of allogenic human stem cell-derived pancreatic islets combined with an immunomodulator for the treatment of Type 1 Diabetes. Kadimastem believes that this collaboration signifies a potentially transformative step in diabetes treatment.
This submission comes after a successful INTERACt ("Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products") meeting, which is a meeting at a specific time early in the product development, between Kadimastem, iTolerance, and the FDA earlier this year. The submission is a significant milestone toward the clinical development of iTOL102, an on-going collaborative research initiative between iTolerance and Kadimastem, funded in part by the Israel-United States Binational Industrial Research and Development Foundation ("BIRD"). iTOL102 combines iTolerance's proprietary SA-FasL microgel (known as iTOL-100), an immune modulator, and IsletRx, insulin-producing islet cells derived from human pluripotent stem cells, to generate an innovative treatment intended for the potential cure of type 1 diabetes.
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