FDA Allows NuvOx Pharma’s IND to Initiate Phase Ib Clinical Trial in Stroke.
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. Administration of NVX-208 prior to t-PA extended the time window of efficacy to at least 9-hours. 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.”
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