Circulating nitrite levels are found normally in our blood. However, in two recent studies, the levels of circulating nitrite levels were shown to be depressed in patients with cardiovascular disease. In the first study, researchers found a negative correlation between circulating nitrite levels in the plasma and cardiovascular risks factors: patients with an increase in the number of risk factors associated with cardiovascular disease had a correspondingly lower level of circulating nitrite.
In the second study, researchers showed that not only did PAD patients and diabetic patients with PAD have a significantly lower level of circulating nitrite than non-PAD patients, but that when these PAD patient groups exercised, no change in circulating nitrite levels were observed, unlike non-PAD patients where exercise induced a 25-30% increase in circulating nitrite levels. While diabetic patients without PAD had a higher level of resting nitrite levels in the blood, like PAD patients, exercise failed to promote the release of nitrite. In a subsequent study, this same research team found that when PAD patients were given a large amount of dietary nitrate, a precursor to nitrate, exercise performance was enhanced. This has important implications in treating PAD patients in that the current standard of care is exercise, to promote blood flow to the affected limb. However, if exercise is not resulting in a release of nitrite, which in turn will limit the amount of nitric oxide made in the limb and the degree of new vascularization, exercise alone may not offer significant benefit. Increasing circulating nitrite levels with TV1001 could alleviate this problem and other cardiovascular problems where circulating nitrite levels are low.
Phase IIa