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NuvOx Pharma LLC Announces Authorization of ARDS Trial from Health Canada

Tucson, AZ,  June 30th, 2024 – NuvOx Pharma LLC (“NuvOx”) announced that it has received authorization from Health Canada for its EXTEND: novEl oXygen ThErapeutic NanO2 for mild respiratory distress in Phase Ib and ARDS in Phase II Trials


Evan Unger, MD, CEO of NuvOx, said, “Acute Respiratory Distress Syndrome (ARDS) has been an important part of our overall development strategy. We recently expanded our protocol inclusion criteria for this trial, aiming to accommodate patients in general respiratory distress. We believe our first-in-class product will be able to help ARDS patients. We are thrilled to receive this authorization.” 


“We have been preparing this trial for the past few months. Products are ready and we have signed up the first clinical site”, added Jennifer Johnson, PhD, CSO of NuvOx, “We are also very grateful to US Department of Health & Human Services, Biomedical Advanced Research and Development Authority (BARDA), with whom we entered into a partnership last year. We look forward to launching the trial.”


Jarrod Mosier, MD, Professor of Emergency Medicine & Medicine, Vice Chair for Research, the University of Arizona, lead author on the article, "The impact of intravenous dodecafluoropentane on a murine model of acute lung injury." Intensive Care Medicine Experimental 11.1 (2023): 33., and Chair of the Data Safety Monitoring Committee for the EXTEND Trial, said, “NanO2 has shown efficacy in animal models of respiratory distress, demonstrating the potential to restore blood oxygen levels, decrease lung inflammation, and improve survival. ARDS has mortality of up to 40% in patients and this disease desperately needs effective therapy. The EXTEND Trials is expected to pave the way for NanO2 as treatment for this deadly disease.”

 

Approximately 10 to 15% of patients admitted to the intensive care units and up to 23% of mechanically ventilated patients meet the criteria for ARDS (1). Despite advances in critical care, ARDS still has high morbidity and mortality(2).  Hypoxia from the inciting illness contributes to various cognitive changes that may persist for months after discharge. Although NanO2‘s safety and efficacy are still under investigation via various clinical trials and has not been granted market authorization by Health Canada, its use in the EXTEND Trial aims at addressing this unmet medical need. 

 

(1) Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A., LUNG SAFE Investigators. ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. [PubMed

 

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This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50123C00034.


About NuvOx Pharma


NuvOx Pharma is a privately held Phase IIb ready company developing a novel oxygen therapeutic where hypoxia plays a role. Hypoxia, or low oxygen, is responsible for resistance to cancer treatment, brain damage in stroke, and the death of COVID-19 patients with acute respiratory distress syndrome (ARDS).


The Company’s lead drug - NanO2TM represents a disruptive platform technology addressing multiple highly unmet needs, with positive clinical efficacy demonstrated in two completed Phase Ib/II studies: in glioblastoma multiforme as a radiosensitizer and in stroke as a neuroprotectant. It was shown to be the most effective oxygen therapeutic among 74 clinical-stage compounds in literature review. It has safety and efficacy data in 7+ indications in various clinical stages, including Orphan Drug Designation for both glioblastoma and sickle cell disease.


The product was derived from Dr. Evan Unger’s pioneering work in microbubbles, which was commercialized as the #1 selling contrast agent. As such, it has 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: 8 Patent Families; 10 issued US patents and foreign equivalents.


NuvOx is conducting a Phase IIb trial as a radiosensitizer in treatment of primary brain cancer, glioblastoma, and also plans to start a Phase IIb trial for NanO2 in treatment of acute ischemic stroke.


Company Contact:


NuvOx Pharma

Dr. Evan Unger, CEO

Rong Wang, President and COO


Investor Contact:

Rong WangT: 520.624.6688

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