Tucson, AZ, April 17, 2022 -- https://www.pr.com/press-release/859467 NuvOx Pharma, a clinical stage biotechnology company developing a first-in-class therapeutic to treat life-threatening diseases where hypoxia plays a role, finalized its manufacturing facility certifications for Phase IIb trials.
In February 2022, NuvOx’s manufacturing facility, which it shares with another Tucson based biotech company, received ISO 7 certification (https://www.pr.com/press-release/854586). To prepare for phase IIb trials that are allowed by FDA, NuvOx further certified the drug filling area in the facility to be Class 5, ISO-14644.
“Such infrastructure upgrade is crucial for our Phase IIb trials in Glioblastoma (GBM) and stroke,” said Dr. Evan Unger, NuvOx’s CEO, “Today’s results stem from significant investment in facility, operations, Quality Management System, and outstanding teamwork.”
“Achieving these certifications cements the environment in which we produce and scale our products, for the upcoming clinical trials and beyond,” said Rong Wang, NuvOx’s Chief Operating and Financial Officer, “Further, being able to manufacturing on-site enhances our control of the product and de-risks the execution to bring this drug to market.”
About NuvOx Pharma
NuvOx Pharma is a privately held Phase IIb ready 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/II studies: in glioblastoma multiforme as a radiosensitizer and in stroke as a neuroprotectant. It was shown to be the most effective therapeutic among 74 clinical-stage compounds tested in pre-clinical stroke models. 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 ultrasound contrast 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. The company also has a strong IP portfolio: 8 Patent Families; 6 issued US patents and 8 pending US applications. Regulated as a Biologic, it confers 12 years of exclusivity.
Dr. Evan Unger, CEO
Rong Wang, COO/CFO