FDA Permits NuvOx Therapeutics to Initiate Phase II REBORN Trial of NanO2 in Recurrent High-Grade Glioma
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Tucson, AZ –March 4, 2026, NuvOx Therapeutics, Inc. (“NuvOx”) today announced that the U.S. Food and Drug Administration (FDA) has authorized NuvOx to proceed with a new Phase II clinical trial evaluating NuvOx’s product candidate NanO2 (the active pharmaceutical ingredient of which is dodecafluoropentane) for the treatment of recurrent high-grade gliomas.
The study, titled REBORN (Radiation Enhancement with Bevacizumab, Lomustine, Oxygen Replenishment, and NanO2 [DDFPe] in Recurrent Gliomas), is a prospective, randomized, double-blind, placebo-controlled Phase II trial designed to evaluate the safety and efficacy of NanO2 as an adjunct to standard therapy in patients with recurrent high-grade glioma. REBORN will enroll 66 patients who will be randomized in a 2:1 ratio to receive NanO2 or placebo in combination with standard-of-care therapy, including bevacizumab, lomustine, and radiation. The primary endpoint of the study is progression-free survival (PFS), with overall survival (OS) as a key secondary endpoint. Both PFS and OS will serve as formal efficacy endpoints for the trial.
High-grade gliomas, including recurrent glioblastoma, remain among the most aggressive and treatment-resistant cancers. Tumor hypoxia is known to limit the effectiveness of radiation therapy. NanO2 is designed to enhance oxygen delivery to hypoxic tumor tissue, with the potential to improve radiation sensitivity and clinical outcomes. NanO2 is a novel oxygen therapeutic designed to transport oxygen to hypoxic tissues. By improving oxygen availability in the tumor microenvironment, NanO2 has the potential to enhance the efficacy of radiation therapy, which relies on oxygen to generate DNA-damaging free radicals.
“This FDA authorization represents a significant milestone for NuvOx and for patients facing recurrent high-grade glioma,” said Dr. Jennifer LH Johnson, Co-founder and Chief Operating Officer of NuvOx. “The REBORN trial is designed to rigorously evaluate whether improving tumor oxygenation with NanO2 can enhance the effectiveness of radiation and meaningfully extend progression-free and overall survival.”
“This is an exciting and meaningful milestone for NuvOx,” said Dr. Evan Unger, Co-founder and Executive Chairman of NuvOx. “I am extremely pleased that the FDA has permitted the REBORN trial to move forward. Recurrent high-grade gliomas remain among the most challenging cancers to treat, and we believe NanO2’s ability to enhance oxygen delivery to hypoxic tumor tissue represents a scientifically sound and potentially transformative approach. The initiation of this trial reflects years of dedicated research and brings us one step closer to improving outcomes for patients facing this devastating disease.”
Dr. Sunil Krishnan, the lead Principal Investigator at the University of Texan at Houston, explained, “There is a tremendous unmet need for patients with recurrent high-grade gliomas, and despite advances in surgery, radiation, and systemic therapy, recurrence remains almost inevitable, and outcomes are poor. Tumor hypoxia is a well-recognized barrier to effective radiation treatment, yet we have limited tools to directly address it. It is both encouraging and reassuring to see this need being properly addressed through a well-designed, randomized clinical trial like REBORN. We are hopeful that this study will help clarify whether improving tumor oxygenation can meaningfully impact progression-free and overall survival for our patients.”
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).
NuvOx’s product candidate, NanO2, is designed to be 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 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.
NanO2 can refer to safety data in ~2,000 subjects, and 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 has completed enrollment in a randomized, placebo-controlled Phase IIb clinical trial as a radiosensitizer in treatment of primary glioblastoma. In this study, the drug was well tolerated. NuvOx has also started a Phase IIb clinical trial for NanO2 in treatment of acute ischemic stroke, funded by the UK government. In addition, NuvOx is conducting a Phase Ib clinical trial for NanO2 in treatment of respiratory distress in Canada, partially funded by BARDA.
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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 proceeding with a new Phase II clinical trial titled REBORN to evaluate NanO2 for the treatment of recurrent high-grade gliomas, enrolling 66 patients in the REBORN trial, the expectation that progression-free survival (PFS) and overall survival (OS) will serve as formal efficacy endpoints, enhancing oxygen delivery to hypoxic tumor tissue, with the potential to improve radiation sensitivity and clinical outcomes, designing NanO2 to transport oxygen to hypoxic tissues, NanO2 having the potential to enhance the efficacy of radiation therapy by improving oxygen availability in the tumor microenvironment, NanO2’s ability to enhance oxygen delivery to hypoxic tumor tissue representing a scientifically sound and potentially transformative approach, improving outcomes for patients facing recurrent high-grade glioma, the study clarifying whether improving tumor oxygenation can meaningfully impact progression-free and overall survival for patients, NanO2 being a disruptive platform technology addressing multiple unmet needs. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our 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. We undertake 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.