The FDA has notified NuvOx Pharma that it may proceed with a clinical trial for its Investigational New Drug (IND), NVX-508 for vaso-occlusive crisis (VOC) and acute chest syndrome (ACS) in sickle cell disease. VOC is one of the most severe complications of sickle cell disease and it typically involves excruciating, debilitating, episodic pain and can contribute to contribute to infection, stroke, multisystem organ damage, and shortened life expectancy. A type of VOC is ACS, which is one of the leading causes of death in these patients. Hypoxia, a low oxygen state in tissues, contributes to the underlying processes in both VOC and ACS. NVX-508 is designed to deliver oxygen to the diseased tissues in patients with sickle cell disease. Evan Unger MD, President and CEO of NuvOx Pharma said, “Acceptance of the IND is a major accomplishment for us. We can now proceed with clinical studies in this indication.”
The clinical trial will be done in collaboration with Dr. Solomon Ofori-Acquah, Associate Professor of Medicine and Human Genetics, and Director of the Center for Translational and International Hematology at the University of Pittsburgh. Dr. Ofori-Acquah said, “Pre-clinical studies of NVX-508 suggest that the drug has great potential to ameliorate symptoms and reverse damage from hypoxia in VOC and ACS in sickle cell disease. Clinical trials are needed to determine if NVX-508 has positive benefits in patients. Acceptance of the IND will allow us to conduct the necessary studies to test the benefits of NVX-508 in patients with sickle cell disease.”
The clinical trial will be the second clinical trial for NuvOx Pharma, which is also conducting a Phase 1b clinical trial for another drug in another indication, NVX-108 for the brain cancer glioblastoma multiforme. The clinical trial for sickle cell disease is expected to start in 2016.