NuvOx Pharma is a biotechnology company based in Tucson, Arizona with a novel patent portfolio allowing it to develop an innovative platform of dodecafluoropentane (DDFP)-based oxygen therapeutics to treat a host of human conditions.
Evan Unger, MD, President and CEO of NuvOx, said, “We are pleased to announce that our platform technology oxygen therapeutic has shown pharmacodynamic effects in our Phase 1b clinical trial in Glioblastoma multiforme (GBM). We are observing radiation sensitizing pharmacodynamics effects that have presumed therapeutic efficacy. We are confirming this with the addition of 3 additional patients at the dose of 0.1 cc/kg of NVX-108.
Consequently, NuvOx has entered the next phase of dose optimization. We are very excited about this, because it corroborates the enormous body of pre-clinical data showing reversal of hypoxia in oxygen-starved disease tissues in the body.”In the escalation phase of the trial, the last patients were treated at doses of 0.1 cc/kg and 0.17cc/kg NVX-108 and showed increased radiation necrosis on post treatment surgeries which is the expected mode of action. Increased radiation necrosis means increased tumor killing, which is the intended outcome.
In addition, the patients treated with doses of 0.1 and 0.17cc/kg had biomarker imaging with MRI confirming reversal of tumor hypoxia. We have three different clinical sites eligible to enroll patients at this time. Following completion of the next three patients at 0.1cc/kg and if no toxicity is observed, we will then enroll 3 more patients at the same dose. The way the adaptive trial process works is if we have 6 patients without any toxicity, then by definition we have reached our recommended therapeutic dose or in the US we call the maximum tolerated dose. GBM is a horrific form of brain cancer with survival of about 12 months after completion of standard of care therapy (surgery followed by radiation therapy with chemotherapy). It kills more than 25,000 people worldwide. GBM tumors have low oxygen levels, making them resistant to radiation therapy. NuvOx’s drug, NVX-108, is designed to restore oxygen levels making the tumors sensitive to radiation therapy. This data in patients gives us the validation of the technology platform that we envisioned when we started the company in 2008 and bolsters our confidence to continue our strategy to pursue other disease indications for oxygen therapy.
This clinical trial in Australia is being conducted in compliance with the Therapeutic Goods Administration under a Clinical Trial Notification, and in accordance with what the FDA would like to see in preparation for an IND application in 2016 to expand the study into a multi-center international trial. NuvOx has applied for Orphan Drug designation for NVX-108 for GBM.
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