Tucson, AZ –December 15, 2025, NuvOx Therapeutics, Inc. (“NuvOx”) announced that the first patient has been enrolled in the Phase IIb NOVEL trial (NanO2 in Large Vessel Occlusion Stroke (NOVEL): a multicenter single-blind, randomized, placebo-controlled biomarker end point clinical trial of perfluorocarbon in acute ischemic stroke due to large vessel occlusion (LVO).
The NOVEL trial is funded by the Efficacy and Mechanism Evaluation (EME) Program, a partnership between the National Institute for Health Care Research (NIHR) and the Medical Research Council (MRC). The trial is also co-sponsored by the University of Glasgow and NHS Greater Glasgow and Clyde.
Professor Keith Muir SINAPSE Professor of Clinical Imaging, University of Glasgow, and Consultant Neurologist, NHS Greater Glasgow and Clyde, said: “We are pleased to have enrolled our first patient in the NOVEL trial. After having achieved regulatory clearance in January of this year, we have made comprehensive clinical preparation for this trial, from material to training. This is just the exciting start. In animal studies and a prior Phase IIa trial in patients with stroke, NanO2 has shown the potential to improve outcomes. We look forward to initiating multiple additional sites and expediting patient enrollment.”
Dr. Evan Unger, NuvOx’s Co-founder and Executive Chairman, said: “We are thrilled to hear about the first patient treated in this important trial. Stroke therapeutics, especially in the neuroprotection area, has a grave unmet medical need. Stroke related disability is a major cost to the healthcare system. It has been a long journey and the idea of this trial has finally come to fruition. Furthermore, we are deeply grateful for the funding from the National Institute of Health and Care Research (NIHR), without which the NOVEL trial would not have been possible.”
“Treating the first patient is always the most difficult step, as it requires so much rigorous preparation.” said Rong Wang, NuvOx’s president and CEO. She added, “We have produced the drug necessary for the trial, and are delighted to have the opportunity to work with Professors Muir and Bath, to witness firsthand how well the trial has been designed and will be carried out. The successful development of NanO2, a nanobubble platform, could offer the potential to save lives and to decrease healthcare costs for the long-term care of stroke patients.”
Over 113,000 individuals suffer a stroke each year in the UK and there are almost 1 million stroke survivors. In 2020, the annual societal cost of stroke in the UK was £25.6 billion. Between 2015 and 2035, the number of strokes in the UK per year is projected to increase by 60% and healthcare costs due to stroke are predicted to triple during this time.1 Recognizing the tremendous burden and cost of stroke in the UK, the National Institute for Health and Care Research (NIHR) has funded a grant to our collaborators to perform the NOVEL Trial in large vessel occlusion (LVO) stroke. LVO stroke is the most severe form of ischemic stroke and is responsible for most mortality and long-term morbidity. Drs. Keith Muir and Philip Bath are principal investigators on the NOVEL trial as well as on the grant that is funding the trial.
The NOVEL trial is planned to be performed on 172 participants with LVO ischemic stroke. These patients will undergo imaging to document LVO and to determine the volume of the at-risk cerebral tissue. Participants will be randomized 1:1 to NanO2 (2% dodecafluoropentane emulsion) or placebo and treated with standard of care reperfusion therapy. At 24-hours following stroke, the participants will undergo an MRI scan to measure the brain infarct size. The primary endpoint of the trial is the size of the brain infarct normalized to the size of the at-risk region. The trial is planned to be performed at a consortium of stroke centers in the UK under the direction of Professors Muir and Bath.
1. King D, Wittenberg R, Patel A, Quayyum Z, Berdunov V, Knapp M. The future incidence, prevalence and costs of stroke in the UK. Age Ageing. 2020 Feb 27;49(2):277-282. doi: 10.1093/ageing/afz163. PMID: 31957781; PMCID: PMC7047821.
About NuvOx:
NuvOx is a privately held clinical stage biopharmaceutical company developing a novel platform of oxygen therapeutics for the treatment of diseases where hypoxia plays a role. Hypoxia, or low oxygen, is responsible for resistance to cancer treatment, brain damage in stroke, and the death of patients with acute respiratory distress syndrome (ARDS).
The Company’s drug candidate, NanO2, represents a disruptive platform technology addressing multiple unmet needs, with positive results demonstrated in two completed Phase Ib/II studies: one in glioblastoma as a radiosensitizer and the other in stroke as a neuroprotectant. It was shown to be the most promising oxygen therapeutic among 74 clinical-stage compounds in literature review. It has safety and efficacy data in 7+ indications in various preclinical and clinical stages, including Orphan Drug Designation for both glioblastoma and sickle cell anemia.
The product can refer to safety data in ~2,000 subjects. The product is designed to be synergistic, rather than competitive with standard of care. The company also has a strong IP portfolio: 11 Patent Families; 11 issued US patents and 31 foreign equivalents.
NuvOx is conducting a Phase IIb clinical trial as a radiosensitizer in treatment of glioblastoma, and started a Phase IIb clinical trial for NanO2 in treatment of acute ischemic stroke, and is conducting a Phase Ib clinical trial for NanO2 in treatment of respiratory distress.
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Forward looking statement
Certain statements in this release may constitute “forward-looking statements.” When used in this release, words like “may,” “will,” “can,” “should,” “expect,” “anticipate,” “believe,” “project,” or “intend” and other similar expressions are intended to identify forward-looking statements. Statements regarding future events and developments and future performance, as well as our expectations, beliefs, plans, or projections, including statements regarding the being confident that the Company deliver data validation to the MHRA within the required 6 months; successful development of NanO2 for stroke treatment offering the potential to save lives and to decrease healthcare costs for long-term care of stroke patients; the planned trial size; and the industry data. Actual events or results may differ substantially as a result of risks and uncertainties facing us. The forward-looking statements are based on current expectations as of the date of these statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of future events, new information, or otherwise.
This trial has been funded in part by the (NIHR) Efficacy and Mechanism (EME) programme grant scheme. The views expressed are those of the authors and not necessarily those of NIHR or the Department of Health and Social Care.
MRC and NIHR
The study was funded by an MRC and NIHR partnership created to support the evaluation of interventions with potential to make a step-change in the promotion of health, treatment of disease and improvement of rehabilitation or long-term care.
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
· Funding high quality, timely research that benefits the NHS, public health and social care;
· Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
· Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
· Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
· Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
· Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.
About the MRC
The Medical Research Council is at the forefront of scientific discovery to improve human health. Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers’ money in some of the best medical research in the world across every area of health. Thirty-three MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed. Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. The Medical Research Council is part of UK Research and Innovation. https://mrc.ukri.org/
SOURCE: https://www.nuvoxtherapeutics.com/post/nuvox-announces-first-patient-in-phase-iib-stroke-trial