105444Oxilia - Towards clinical translation of nanoparticle enhanced radiotherapy for inoperable and difficult to treat cancersClosedCollaborative R&DInnovate UKXerion 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.