News — SUMMIT, NJ – JUNE 26, 2023 – The Gerald J. Glasser Brain Tumor Center at Overlook Medical Center, part of Atlantic Health System, recently became the first site in the nation to dose a patient in the Phase IIb RESTORE Trial for newly-diagnosed glioblastoma tumors.
The new treatment is developed by NuvOx Pharma, a clinical stage biotechnology company developing a first-in-class therapeutic to treat life-threatening diseases where hypoxia – low levels of oxygen in body tissue - plays a role.
This phase of the trial’s primary objective is to determine progression free survival (PFS) in newly-diagnosed glioblastoma patients after treatment with NanO2 TM– the company’s lead drug - in combination with radiation and chemotherapy.
Glioblastomas typically contain significant regions of hypoxic tissue. The cause of the hypoxia is uncertain, but it might arise from thrombosis of small blood vessels due to production of pro-coagulant factors by the tumor cells. Hypoxia leads to necrosis of parts of the tumor and other conditions – an important consequence being relative resistance to therapeutic radiation. Similarly, hypoxic cells can become resistant to chemotherapy.
The hypothesis for investigators in the RESTORE trial, such as the Glasser Brain Tumor Center’s co-director, neurooncologist Robert Aiken, MD, is that increasing oxygen delivery to hypoxic glioblastoma tissue via NanO2 will boost the effectiveness of frontline treatment with both radiation therapy and chemotherapy.
“The challenge of getting more oxygen into hypoxic tissues affected by tumors has plagued the medical community for some time,” Dr. Aiken said. “Many medications have been tried, without success. “Using NanO2 to infuse the tissues with oxygen is a promising strategy that could be potentially life-extending.”
NanO2 is an emulsion of dodecafluoropentane (DDFP) that, when administered intravenously, helps facilitate the transfer of oxygen into the tumor, making it more susceptible to conventional radiation strategies.
The rationale is to increase the amount of oxygen being delivered in blood to the tumor and therefore to increase sensitivity to irradiation. Patients will also receive a standard regimen of concurrent chemotherapy.
“It’s a relatively easy medication to administer,” Dr. Aiken further noted. The push-intravenous NanO2 will be performed in outpatient infusion at Overlook.
Overlook Medical Center, the flagship of Atlantic Health System’s neuroscience program, has long been at the forefront of using vaccines to treat brain tumors. Overlook’s Gerald J. Glasser Brain Tumor Center gives hope to more than a thousand families every year. The center is located in the heart of Atlantic Neuroscience Institute at Overlook, which has been nationally recognized for neuroscience care.
Overlook’s capabilities in treating brain tumors, including an integrated care team, cutting-edge surgical procedures like CyberKnife, as well as conformal radiation, targeted therapy and chemotherapy, surgery guided by fluorescent imaging, brain mapping and awake surgery – in addition to supportive care and comprehensive symptom management – makes it uniquely suited for the trial among hospitals in the region.
“We are thrilled to start treating patients for this trial. Glioblastoma is one of the deadliest cancers and a rare disease,” said Dr. Evan Unger, CEO and co-founder of NuvOx said. “The work in this area is greatly impactful. In addition, this trial significantly advances our oxygen therapeutics’ application in oncology, due to the commonality of tissue hypoxia in solid tumors.”
“We are extremely grateful for our clinical partners, such as Overlook Medical Center. Their dedication for their patients is deeply appreciated. The clinicians and their teams have worked hard to get the first dose to the first patient in the RESTORE Trial. We hope to see great results.” added Scott Gellert, Vice President of Clinical Operations at NuvOx.
More information about the trial can be found at : NCT03862430. For more information about the trial at Overlook, email [email protected]
About NuvOx
NuvOx is a privately held, clinical Phase IIb stage 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/IIa studies: in glioblastoma multiforme as a radiosensitizer and in stroke as a neuroprotectant. It was shown to be the most effective oxygen therapeutic from the literature survey from 74 clinical-stage compounds. It has safety and efficacy data in 7+ indications in various clinical stages, including Orphan Drug Designation for both glioblastoma multiforme and sickle cell disease.
The product was derived from Dr. Evan Unger’s pioneering work in microbubbles, which was commercialized as the #1 selling contract 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.
About Atlantic Health System
Atlantic Health System is at the forefront of medicine, setting standards for quality health care in New Jersey, Pennsylvania and the New York metropolitan area. Powered by a workforce of 19,000 team members and 5,440 affiliated physicians dedicated to building healthier communities, Atlantic Health System serves more than half of the state of New Jersey including 12 counties and 6.2 million people. The not-for-profit system offers more than 400 sites of care, including its seven hospitals: Morristown Medical Center in Morristown, NJ, Overlook Medical Center in Summit, NJ, Newton Medical Center in Newton, NJ, Chilton Medical Center in Pompton Plains, NJ, Hackettstown Medical Center in Hackettstown, NJ, Goryeb Children’s Hospital in Morristown, NJ, Atlantic Rehabilitation Institute in Madison, NJ and through its partnership with CentraState Healthcare System in Freehold, NJ.
The system includes Atlantic Medical Group, part of a physician enterprise that makes up one of the largest multispecialty practices in New Jersey with more than 1,600 physicians and advance practice providers. Joined with Atlantic Accountable Care Organization and Optimus Healthcare Partners they form part of Atlantic Alliance, a Clinically Integrated Network of more than 2,500 health care providers throughout northern and central NJ.
Atlantic Health System provides care for the full continuum of health care needs through 24 urgent care centers, Atlantic Visiting Nurse and Atlantic Anywhere Virtual Visits. Facilitating the connection between these services on both land and air is the transportation fleet of Atlantic Mobile Health.
Atlantic Health System leads the Healthcare Transformation Consortium, a partnership of six regional hospitals and health systems dedicated to improving access and affordability and is a founding member of the PIER Consortium – Partners in Innovation, Education, and Research – a streamlined clinical trial system that will expand access to groundbreaking research across five health systems in the region.
Atlantic Health System has a medical school affiliation with Thomas Jefferson University and is home to the regional campus of the Sidney Kimmel Medical College at Morristown and Overlook Medical Centers and is the official health care partner of the New York Jets.
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