Tucson, AZ (PRWEB) December 03, 2015
NuvOx Pharma, a clinical stage pharmaceutical company from Tucson AZ, is continuing to collect data in a Phase 1b clinical trial for Glioblastoma Multiforma (GBM). 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.
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 clinical trial in GBM. We are observing radiation sensitizing pharmacodynamics effects that have presumed therapeutic efficacy. We are confirming this with the addition of three 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. 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.”
In the dose 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. The company has 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, three more patients will be enrolled at the same dose. After a total of six patients are treated at a dose without toxicity, then the recommended therapeutic dose will have been reached.
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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