Oxilia - Towards clinical translation of nanoparticle enhanced radiotherapy for inoperable and difficult to treat cancers

Oxilia - 针对无法手术和难以治疗的癌症的纳米颗粒增强放射治疗的临床转化

• 批准号: 105444
• 金额: $ 111.58万
• 依托单位: XERION HEALTHCARE LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2019
• 资助国家: 英国
• 起止时间: 2019 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=105444
• 关键词: Oxilia; Towards; clinical; translation; nanoparticle

Xerion Healthcare Ltd ("Xerion") have developed a highly innovative and cost-effective nanoparticle technology, Oxilia. This technology is intended to augment standard radiotherapy to provide more effective treatment for patients with inoperable cancers, with the primary focus on head and neck (HNC) and pancreatic cancers. Current therapies are not adequate for effective treatment of such cancers, and this improved treatment regime is likely to offer a significantly better prognosis for patients, extending lives of patients with previously untreatable cancers, while considerably reducing treatment costs.Oxilia is made up of novel titanium dioxide nanoparticles, doped with a rare earth metal, giving it unique properties and allowing the generation of free radicals from water during radiotherapy. This permits treatment of aggressive and challenging hypoxic tumours, which are deficient in the very oxygen required to generate the cancer killing free radicals, during conventional radiotherapy. This innovative approach has shown increased cancer cell death in lab studies, with 1.9x the cell killing capacity of conventional radiotherapy in pancreatic cancer cells. To translate these results obtained from preclinical studies to clinical practice, Xerion have to obtain authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) to commence clinical trials. The main aims of this project are to meet MHRA requirements by:-Completing animal efficacy and dose response studies, and pharmacokinetic, biodistribution and toxicity studies;-Demonstrating that production quality requirements can be met.The defined outcomes of Oxilia project are:-Demonstration that the current process can be scaled 20-fold in a compliant clean production environment, capable of producing up to 8,000 complete treatment kits per annum per reactor,-MHRA authorisation for a pilot clinical trial using the complete treatment kits developed within the project,-Capability to serve 100% of UK and 25% of EU unresectable HNC market, demonstrating feasibility of increasing the manufacturing scale.Successful completion will allow Xerion to undertake clinical tests and commercialise Oxilia for HNC and pancreatic cancers. By 2028, Xerion expect to be treating up to 15,000 HNC patients across the UK and the EU, thereby significantly improving the quality of life for many people suffering from unresectable cancers.

Xerion医疗保健有限公司（“Xerion”）开发了一种高度创新和具有成本效益的纳米颗粒技术Oxilia。该技术旨在增强标准放疗，为无法手术的癌症患者提供更有效的治疗，主要集中在头颈部（HNC）和胰腺癌。目前的治疗方法不足以有效治疗这类癌症，而这种改进的治疗方案可能会为患者提供明显更好的预后，延长以前无法治疗的癌症患者的生命，同时大大降低治疗成本。Oxilia由新型二氧化钛纳米颗粒组成，掺杂了稀土金属，赋予其独特的性能，并允许在放射治疗期间从水中产生自由基。这就允许在常规放射治疗期间治疗侵袭性和挑战性的缺氧肿瘤，这些肿瘤缺乏产生癌症杀伤自由基所需的氧气。在实验室研究中，这种创新的方法已经显示出癌细胞死亡的增加，对胰腺癌细胞的细胞杀伤能力是传统放疗的1.9倍。为了将这些临床前研究结果转化为临床实践，Xerion必须获得药品和保健产品监管机构（MHRA）的授权才能开始临床试验。该项目的主要目的是通过：-完成动物功效和剂量反应研究，以及药代动力学，生物分布和毒性研究；-证明能够满足生产质量要求。Oxilia项目的确定结果是：-证明目前的工艺可以在合规的清洁生产环境中扩展20倍，每个反应器每年能够生产多达8,000个完整的治疗试剂盒；-MHRA授权使用项目中开发的完整治疗试剂盒进行试点临床试验；-能够为100%的英国和25%的欧盟不可切除的HNC市场提供服务，证明增加生产规模的可行性。该项目的成功完成将允许Xerion进行临床试验，并将Oxilia商业化用于HNC和胰腺癌。到2028年，Xerion预计将在英国和欧盟治疗多达15,000名HNC患者，从而显着改善许多患有不可切除癌症的患者的生活质量。