TUCSON, Ariz.--(BUSINESS WIRE)--NuvOx Pharma announces that the first patients have been dosed in a
Phase Ib/II clinical trial for NVX-208, an oxygen therapeutic being
developed for acute ischemic stroke. The trial is being performed at the
University of Arkansas for Medical Sciences in Little Rock, Arkansas,
under the direction of Dr. William Culp, the Jonathan Fitch
Distinguished Chair in Stroke. 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 the thrombolytic drug 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 nine hours.”
This Phase Ib/II trial is a randomized, placebo controlled, blinded,
dose escalation trial that will enroll up to 24 patients. The primary
endpoint is to find the maximum tolerated dose for NVX-208. Although the
drug will not be used to extend the time window for the clot-busting
drug t-PA in this trial, it may still have a beneficial effect on
outcomes in stroke patients and the researchers will look to see if
there is a trend in NIH Stroke Scale, a measurement of stroke severity
in the patients. NuvOx Pharma CEO Evan Unger, MD, says, “NVX-208 has
great potential to allow many more stroke patients to be treated and to
improve their outcomes. Stroke is the fifth leading cause of death in
the U.S. and a leading cause of serious long term disability. It costs
the U.S. an estimated $33 billion per year. Improved treatment could not
only decrease mortality and morbidity but also decrease health care
costs.”
NuvOx is a privately held biotechnology company based in Tucson,
Arizona. NuvOx conducted a Phase Ib/II clinical trial of NVX-108 in
patients with brain cancer and has an active IND for sickle cell disease
for NVX-508.
Disclaimer: Certain statements in this release may constitute
“forward-looking statements.” Actual events or results may differ
substantially as a result of risks and uncertainties facing us. We
undertake no obligation to publicly update or revise any forward-looking
statements, as a result of future events, new information, or otherwise.
Contacts
NuvOx Pharma
John McGonigle
