NuvOx Pharma receives FDA Orphan Drug Designation for Oxygen Therapeutic for Vaso-occlusive Crisis and Acute Chest Syndrome in Sickle Cell Disease

Tucson, AZ, February 14, 2016 --( Tucson based pharmaceutical company NuvOx Pharma announced today that it has secured orphan drug designation from the FDA for its investigational drug 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.

NuvOx Pharma’s CEO, Evan Unger, MD, 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. The orphan drug designation is an important regulatory advancement as we further our development efforts.” Dr Unger explained that there is a critical need for new therapies for sickle cell disease, as only one drug has been approved by the FDA for treatment of the disease and that approval occurred 18 years ago. That drug, hydroxyurea, reduces the occurrence of VOC and ACS, but it does not eliminate the crises and it is not approved to treat the acute events – in fact there currently is no drug approved to treat acute crises. NVX-508 aims to fill this gap. NuvOx has received the go-ahead from the FDA to conduct a Phase 1b clinical trial in sickle cell disease.

About Orphan Drug Designation:
The Orphan Drug Act provides for granting special status to a drug or biological product to treat a rare disease or condition upon the request of a sponsor. In the US, this status is granted to medicines intended for the safe and effective treatment of diseases that affect fewer than 200,000 people. Orphan status provides sponsors with development and commercial incentives such as tax credits for qualified clinical testing and market exclusivity for 7 years after the marketing approval is granted.

Certain statements in this release may constitute “forward-looking statements.” When used in this release, words like “may,” “will,” “can,” “should,” “expect,” “anticipate,” “believe,” “project,” or “intend” and other similar expressions are intended to identify forward-looking statements. Statements regarding future events and developments and future performance, as well as our expectations, beliefs, plans, or projections, are forward-looking statements which reflect only our predictions, assumptions, and estimates regarding future events and circumstances. Actual events or results may differ substantially as a result of risks and uncertainties facing us. The forward-looking statements are based on current expectations as of the date of these statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of future events, new information, or otherwise.
NuvOx Pharma
John McGonigle
(520) 624-6688