'First-In-Human' directed pre-clinical development of anti-cancer agent CYC140

“首次人体”指导抗癌药物 CYC140 的临床前开发

• 批准号: 101448
• 金额: $ 288.54万
• 依托单位: CYCLACEL LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2013
• 资助国家: 英国
• 起止时间: 2013 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=101448
• 关键词: First; Human; directed; pre; clinical

Cyclacel has developed a clinical candidate NCE with characteristics enabling the targeting of a previously unexploited mechanism for treatment of oesophageal cancer (OEC), an orphan disease with a high unmet need. This potent and selective PLK1 kinase inhibitor has a strong preclinical rationale for use as a stratified medicine for OEC and other solid tumour indications having particular driver mutations. The drug development project encompasses preclinical validation of marker assays for clinical stratification of patients, 'First-In-Human' (FIH)-directed safety studies, clinical formulation and manufacture for Phase 1 testing, and testing of the compound in combination with approved and investigational therapeutic agents in models of the target diseases. Success will attract further investment in a UK and EU based development program, securing additional jobs and will provide access to a new investigational medicine for solid tumour patients with poor prognosis diseases.

Cyclacel开发了一种临床候选NCE，其特征能够靶向治疗食管癌（OEC）的先前未开发的机制，这是一种具有高度未满足需求的孤儿病。这种有效的选择性PLK1激酶抑制剂具有很强的临床前基础，可用作OEC和其他具有特定驱动突变的实体瘤适应症的分层药物。该药物开发项目包括临床前验证用于患者临床分层的标记物测定，“首次人体”（FIH）指导的安全性研究，临床制剂和1期测试的生产，以及在目标疾病模型中测试化合物与批准的和研究性治疗药物的组合。成功将吸引对英国和欧盟发展计划的进一步投资，确保额外的就业机会，并将为预后不良的实体瘤患者提供获得新的研究药物的机会。