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

Xarion Healthcare Ltd(“Xarion”)开发了一种极具创新性和成本效益的纳米颗粒技术Oxilia。这项技术旨在加强标准放射治疗，为不能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地治疗这种癌症，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，同时显著降低治疗成本。氧化钛由新型二氧化钛纳米颗粒组成，掺入稀土金属，赋予其独特的性质，并允许在放射治疗过程中从水中产生自由基。这使得治疗侵袭性和挑战性的低氧肿瘤成为可能，在传统的放射治疗中，这些肿瘤缺乏产生癌症杀灭自由基所需的氧气。这种创新的方法在实验室研究中表明，癌细胞死亡增加，胰腺癌细胞的杀伤力是传统放射治疗的1.9倍。为了将这些从临床前研究中获得的结果转化为临床实践，Xarion必须获得药品和保健品监管机构(MHRA)的授权才能开始临床试验。该项目的主要目的是通过以下方式满足MHRA的要求：-完成动物疗效和剂量反应研究，以及药代动力学、生物分布和毒性研究；-证明生产质量要求是可以达到的。Oxilia项目的明确成果是：-证明目前的工艺可以在合规的清洁生产环境中扩大20倍，每个反应堆每年能够生产多达8000个完整的治疗套件，-MHRA授权使用项目内开发的完整治疗套件进行试点临床试验，-有能力服务于100%的英国和25%的欧盟不可切除的HNC市场，证明了扩大制造规模的可行性。成功完成将使Xarion能够进行临床测试并将Oxilia用于HNC和胰腺癌的商业化。到2028年，Xarion预计将在英国和欧盟治疗多达15,000名HNC患者，从而显著提高许多患有无法手术的癌症患者的生活质量。

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.