IND-Enabling Pre-Clinical Studies of 2DG for Treatment of Epilepsy

2-脱氧-D-葡萄糖(2DG)具有广泛的抗癫痫发作相关的细胞和网络机制。2DG在发病后10分钟给药时，也可抑制点燃发作的进展。这不仅意味着抗惊厥活性，而且有可能改变疾病，2DG治疗可能减轻癫痫发作的慢性后果，如易患难治性和认知和记忆功能障碍。这些特征将2DG与目前市场上所有的抗惊厥药物区分开来。此外，2DG治疗癌症的临床前毒性研究和人类I/II期临床试验表明，有效对抗癫痫发作的剂量具有良好的耐受性。 Bridgs团队合作完成了以下针对2DG的研究： -良好制造规范(GMP)和非GMP材料的综合 -药物产品配方开发和生产，以支持第一阶段研究 -药代动力学/吸收、分布、代谢和排泄(PK/ADME)研究 -研究新药(IND)指导的毒理学

2-Deoxy-D-Glucose (2DG) has a broad spectrum of action against a variety of cellular and network mechanisms underlying epileptic seizures. 2DG also impairs the progression of kindled seizures when administered as long as 10 minutes after onset. This implies not only an anticonvulsant activity, but a potential for disease modification, with 2DG treatment potentially mitigating against chronic consequences of seizures, such as susceptibility to intractability and cognitive and memory dysfunction. These features distinguish 2DG from all currently marketed anticonvulsants. Moreover, pre-clinical toxicity studies and human Phase I/II clinical trials of 2DG for treatment of cancer have demonstrated that doses effective against seizures are well tolerated. The BrIDGs team collaborated on the completion of the following studies for 2DG: - Synthesis of Good Manufacturing Practice (GMP) and non-GMP material - Formulation development and manufacture of drug product to support Phase I studies - Pharmacokinetic/absorption, distribution, metabolism, and excretion (PK/ADME) studies - Investigational New Drug (IND)-directed toxicology