NuvOx Announces Independent DSMB Recommendation to Continue NOVEL Stroke Trial Without Modification
Tucson, AZ – October 12, 2026, NuvOx Therapeutics, Inc. (“NuvOx”), a clinical-stage biotechnology company developing NanO2™, a novel oxygen therapeutic designed to enhance oxygen delivery to oxygen-deprived tissues, today announced that the independent Data Safety Monitoring Board (DSMB) has recommended the continuation of the phase IIb trial - NanO2 in Large VessEL Occlusion Stroke (NOVEL): a multicentre single-blind, randomised, placebo-controlled trial evaluating the safety, tolerability and preliminary efficacy of NanO2 in acute ischemic stroke due to large vessel occlusion (LVO).
NOVEL is a randomized, placebo-controlled, 1:1, blinded clinical trial evaluating NanO2 in patients with acute ischemic stroke as a neuroprotectant. The independent DSMB conducts its safety review using unblinded treatment data, allowing it to evaluate the accumulating safety data by treatment group while maintaining the blindness of the study for investigators and participants. Review of the unblinded data also allows the DSMB to evaluate whether the trial should be terminated for futility.
Following its scheduled review of data from the first 23 patients enrolled and treated in NOVEL, the independent DSMB recommended that the trial continue without modification.
Professor Keith Muir, SINAPSE Professor of Clinical Imaging, University of Glasgow, and Consultant Neurologist, NHS Greater Glasgow and Clyde said, “We are pleased that the independent DSMB has reviewed the unblinded safety data from the first 23 patients and has recommended that the trial continue as planned. The DSMB’s recommendation is an important milestone for the study and allows us to continue evaluating NanO2 in this challenging clinical setting.”
“We are very encouraged by the independent DSMB’s recommendation.” said Evan Unger, BOD Chairman of NuvOx, “We are grateful to the patients, investigators and clinical teams participating in NOVEL and look forward to continuing the study.”
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 is projected to increase by 60% per year and healthcare costs associated with strokes are predicted to triple during this time. Recognizing the tremendous burden and cost of stroke in the UK, a UKRI Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) partnership has funded a grant to perform the NOVEL Trial in large vessel occlusion (LVO) stroke. The NOVEL Trial is sponsored by the University of Glasgow and NHS Greater Glasgow and Clyde.
LVO stroke is the most severe form of ischemic stroke and is responsible for a disproportionately large share of post-stroke mortality and long-term morbidity. Professors. Keith Muir and Philip Bath are principal investigators on the NOVEL trial as well as on the grant that is funding the trial.
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.
Additional information about the trial is available at ClinicalTrials.gov (NCT06821347).
The NOVEL Trial is funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation Programme and Co-sponsored by the University of Glasgow and NHS Greater Glasgow and Clyde.
About NuvOx:
NuvOx is a clinical-stage biopharmaceutical company developing innovative oxygen therapeutic solutions for the treatment of diseases where hypoxia, or lack of oxygen, plays a critical role. The focus of NuvOx’s clinical research and development to date has been on the administration of NanO2 to treat acute ischemic stroke, glioblastoma multiforme (GBM) and acute respiratory distress syndrome (ARDS).
NuvOx’s product candidate, NanO2, the API of which is dodecafluoropentane, is a platform technology designed to address multiple unmet needs, with two completed Phase Ib/II studies: one in glioblastoma as a radiosensitizer and the other in stroke as a neuroprotectant. It has safety and efficacy data in 7+ indications in various preclinical and clinical stages and Orphan Drug Designation for both glioblastoma and sickle cell anemia.
NanO2 is designed to be synergistic, rather than competitive, with standard of care. NuvOx also has a strong IP portfolio: 11 issued US patents and 32 foreign equivalents.
In addition to the NOVEL trial, NuvOx has completed the enrollment and treated 93 patients in a Phase IIb clinical trial administering NanO2 in the United States to treat GBM and are now in the follow up period. In this study, the drug was well tolerated. NuvOx is also conducting a Phase Ib clinical trial for NanO2 in treatment of respiratory distress in Canada, partially funded by BARDA.
Forward-looking statement:
This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing.
The forward-looking statements include statements regarding the potential of NanO₂ to enhance oxygen delivery to oxygen-deprived tissues, continuing to evaluate NanO2 in the NOVEL study, the potential of NanO₂ to address multiple unmet needs, and NanO2 being synergistic, rather than competitive with standard of care.
Any forward-looking statements included herein reflect NuvOx’s current views, and they involve certain risks and uncertainties, including, among others, NuvOx’s ability to pursue its regulatory strategy, NuvOx’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, NuvOx’s ability to develop strategic partnership opportunities and maintain collaborations, NuvOx’s ability to obtain or maintain the capital or grants necessary to fund its research and development activities, NuvOx’s ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to NuvOx’s ability to promote or commercialize its product candidates for specific indications, acceptance of NuvOx’s product candidates in the marketplace and the successful development, marketing or sale of its products, NuvOx’s ability to maintain its license agreements, the continued maintenance and growth of NuvOx’s patent estate and NuvOx’s ability to retain its key employees. These risks should not be construed as exhaustive. Any forward-looking statement speaks only as of the date on which it was initially made. NuvOx undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
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MRC and NIHR
The NOVEL 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. NIHR does 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 NIHR’s 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/
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