Overlook Becomes Trial Site for Brain Tumor Treatment

The Gerald J. Glasser Brain Tumor Center at Overlook Medical Center in Summit, part of Atlantic Health System, has become 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.

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