FDA Allows NuvOx Pharma’s IND to Initiate Phase Ib Clinical Trial in Stroke

Tucson, AZ, August 22, 2016 --(PR.com)-- Evan Unger, MD, President and CEO of NuvOx, announced that the FDA has allowed an investigational new drug application (IND) for NVX-208 (dodecafluoropentane emulsion) to be tested in a Phase Ib trial in stroke patients. The trial will be performed at the University of Arkansas Medical System in Little Rock, Arkansas under the direction of Dr. William Culp, Jonathan Fitch Distinguished Chair in Stroke. Dr. Culp said, “We have studied NVX-208 in a number of pre-clinical stroke models and found that administration of NVX-208 decreases the brain damage from stroke by over 80%. The only approved drug to treat stroke is t-PA, which has a risk of bleeding and is approved for use only up to 3 hours following stroke. NVX-208 has great potential to allow many more stroke patients to be treated and to improve their outcomes. This trial will determine the recommended dose of NVX-208 in stroke patients so that it can be subsequently tested in a randomized study in stroke patients. Clinical trials are needed to see if NVX-208 can become approved by regulators.”

NuvOx is a privately held biotechnology company based in Tucson, Arizona. NuvOx is presently conducting a Phase Ib/II clinical trial of NVX-108 in patients with brain cancer and already has an active IND for sickle cell disease for NVX-508. NuvOx has received Orphan Drug designation form the FDA for NVX-108 for brain cancer and for NVX-508 for sickle cell disease. For further information, please contact John McGonigle at jmcgonigle@nuvoxpharma.com.

Disclaimer: 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.