Based in Tucson, Arizona, NuvOx Pharma is working to solve one of medicine’s quieter but deeply serious problems: cellular hypoxia, or what happens when the body’s tissues don’t get enough oxygen. Their lead product, NanO2, is designed to restore that balance, and the conditions they’re targeting are anything but small.
Their Mission:
NuvOx’s mission is to reduce or eradicate health problems caused by cellular hypoxia. A few of these hypoxic conditions are stroke, myocardial infarction (MI), Acute Respiratory Distress Syndrome (ARDS), and cancer. Their main product is called NanO2, and it rebalances respiratory gases in hypoxic and hypercapnic tissue to a healthy state and improves clinical outcomes. They ensure the availability of their clinical product (NanO2) for all of their clinical trials promptly and aim to exceed an 80% success rate in internal manufacturing. They also do their analytical release and stability testing in-house under cGMP requirements. All of their equipment is qualified and calibrated, and all of their test methods have been validated. The quality of everything they do is very important to them as partially evidenced by their highly developed and well-accepted cGMP Quality Management System. NuvOx is committed to delivering safe, effective, and high-quality products that meet or exceed user expectations and comply with all applicable regulatory requirements. They have established and continue to maintain a culture of continuous improvement through their Quality Management System. Every NuvOx employee is responsible for quality, and NuvOx ensures that appropriate training, communication, and resources are provided to support this commitment. They are happy to help out other local companies in the areas they have learned are important for progress and invite such contacts if they can be of assistance.
What Health Challenge Is NuvOx Working to Address?
NuvOx is currently running 3 clinical trials in 3 different indications: Glioblastoma (brain cancer), Stroke and ARDS. They also have pre-clinical programs in MI, Organ preservation, Traumatic Brain Injury (TBI), Hemorrhagic Shock, Triple Negative Breast Cancer (TNBC), and Sickle Cell Disease.
What Makes NuvOx’s Approach or Technology Unique?
NanO2 contains the only fluorocarbon (FC) still under development for hypoxic and hypercapnic conditions. The specific FC in NanO2 is the most unique aspect. It is dodecafluoropentane (C5F12), which goes through a phase transition (from liquid to gas) at biological temperature and delivers a more plentiful oxygen payload as well as picks up excess carbon dioxide. It is incredibly stable and non-reactive. The drug is 100% excreted unchanged via exhalation in about 8 hours after dosing.
How Is NuvOx’s Work Impacting Patients, Providers, or the Healthcare System?
Patients are presumed to be positively impacted by the treatment with NanO2. There have been no NanO2-related SAEs in any of their 3 ongoing trials. In all 3 cases, the treatment may prolong or save lives. Providers are given reason to hope that their loved one may rebound. The healthcare system benefits from the ease of administration of the NanO2 and the fact that it simply needs to be added to the standard of care for the condition being treated.
What Milestones or Achievements Is NuvOx Most Proud Of?
They are proud that they were able to work together as a cohesive team to renovate the building to make it cGMP compliant. They were formally audited by a Qualified Person (QP) from the UK to state that they conform to European Annex 1. They are also proud that they have taken so many parts of drug development in-house. This has enabled them to gain a solid understanding of requirements and how to implement them. While they are a small company, they have the expertise to do their own accounting work, regulatory writing, grant writing, statistical analysis, business development, and fundraising.
What’s Next for NuvOx?
They are anxiously awaiting the data reveal for their 93-patient glioblastoma trial. The trial was double-blinded, so NuvOx does not know the results yet. Results will not be revealed until a certain statistically determined number of patients have shown disease progression. Roughly speaking, the longer they have to wait, the more benefit the patients are exhibiting as compared to historical control groups.
About the Author
Ava Woods
Ava Woods is the Marketing & Communications Intern at AZBio, supporting digital communications, content creation, and member engagement initiatives. In her role, Ava assists with social media management, marketing campaigns, event promotion, and storytelling efforts that highlight Arizona’s growing bioscience community.
About AZBio Member Spotlights
AZBio Member Spotlights are just one of the ways AZBio is building awareness of the health innovations being developed and delivered across the state of Arizona. Telling Arizona’s Bioscience Story is a key goal of Arizona’s Bioscience Roadmap, the nation’s longest-running statewide strategic plan designed to build a robust bioscience sector.