Tucson, AZ – January 21,2025 – NuvOx Therapeutics, Inc. (“NuvOx”) announced that The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom in collaboration with the Research Ethics Committee has accepted the amended request for a clinical trial authorisation (CTA). This acceptance will enable the company to commence the Phase IIb NOVEL trial (NanO2 in Large VessEL Occlusion Stroke (NOVEL): a multicentre single-blind, randomised, placebo-controlled blinded biomarker end-point clinical trial of perfluorocarbon in acute ischaemic stroke due to large vessel occlusion (LVO).
The NOVEL trial is funded by the Efficacy and Mechanism Evaluation (EME) Programme, a partnership between the National Institute for Health Care Research (NIHR) and the Medical Research Council (MRC). The trial is also co-sponsored by University of Glasgow and NHS Greater Glasgow and Clyde.
Professor Keith Muir, SINAPSE Professor of Clinical Imaging & Consultant Neurologist, University of Glasgow, said, “We are pleased to be able to commence the NOVEL trial. In animal studies and a prior Phase IIa trial in patients with stroke, NanO2 has shown potential to improve outcomes in stroke. The product candidate appears to maintain the viability of the neurons within the at-risk region of the brain until blood flow can be restored. The NOVEL trial sample size has been selected to power the trial such that we should be able to determine the potential of NanO2 to decrease brain infarct size in LVO stroke. Ultimately, decreasing infarct size should translate to improved functional outcome.”