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The Effects of an Oral Nitric Oxide Lozenge on Peripheral Artery Disease

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AT009171-01A1
Agency Tracking Number: R41AT009171
Amount: $155,772.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 213
Solicitation Number: PA15-270
Solicitation Year: 2016
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-30
Award End Date (Contract End Date): 2017-09-29
Small Business Information
Spicewood, TX 78669-3023
United States
DUNS: 832851963
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (713) 500-2461
Business Contact
Phone: (512) 773-9097
Research Institution

Peripheral artery disease PAD is a common circulatory problem in which narrowed arteries reduce blood flow
to your limbs thereby restricting blood flow During exercise or simply walking there is not sufficient blood flow
to keep up with the metabolic demand This causes symptoms most notably leg pain when walking intermittent
claudication PAD is also likely to be a sign of more widespread atherosclerosis which may be reducing blood
flow to your heart and brain and other parts of the body and not be isolated to just the legs Therefore improving
blood flow to the legs in patients with PAD will likely improve blood flow to other organs as well Reduced nitric
oxide NO availability or endothelial dysfunction is a hallmark of a number of cardiovascular disorders including
PAD L Arginine is the precursor of endothelium derived nitric oxide an endogenous vasodilator L Arginine
supplementation improves vascular reactivity and functional capacity in PAD in small short term studies
However long term administration of L arginine does not increase nitric oxide synthesis or improve vascular
reactivity As opposed to its short term administration long term administration of L arginine is not useful in
patients with intermittent claudication and PAD The objective of this application is to determine if restoring NO
through an orally disintegrating tablet that releases authentic NO gas can improve blood flow and intermittent
claudication in patients with PAD The central hypothesis of this application is that a nitric oxide generating tablet
can dilate blood vessels improve blood vascular reactivity and functional capacity in patients with PAD This
same technology has already been shown to dilate blood vessels improve vascular reactivity and functional
capacity in hypertensive and pre hypertensive patients If successful this non prescription over the counter
formulation can provide a safe effective and affordable solution for patients with PAD and perhaps improve long
term outcomes in patients with vascular disorders Project Narrative
There are approximately million individuals in the US with peripheral artery disease PAD although many are
undiagnosed Our poor record in diagnosing these individuals is in part due to insufficient education of the lay
public Insufficient nitric oxide NO production is a hallmark of a number of vascular disorders including PAD
Restoring NO availability through a nitric oxide generating lozenge may have important therapeutic effects in
improving blood flow and functional capacity in patients with PAD A new therapy to improve walking distance
in these individuals could improve their quality of life reduce major adverse cardiovascular events MACE by
permitting them to increase their physical activity

* Information listed above is at the time of submission. *

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