TheraVasc
has recently completed a Phase I clinical trial under the
direction of Dr. Frank Greenway at the Pennington Biomedical
Research Center, a leader in obesity and diabetes
research. Dr. Greenway, the Medical Director at
Pennington, has substantial experience in conducting clinical
trials on obesity on diabetes.
A total
of 12 diabetic patients were enrolled and received two
different formulations of 80 mg of sodium nitrite, an
enteric-coated and a non-enteric coated capsule, with a
minimum of two weeks between dosing. There were no
serious adverse events, with only three of the twelve subjects
reporting any adverse events (headache, flushing, feeling of
nausea) all of which resolved within an hour, thus
demonstrating that the 80 mg dose is well-tolerated in
patients.
Circulating nitrite levels were measured at Emory
Medical School and University of Alabama, Birmingham using
two different methodologies. The results were similar
between the two. Peak nitrite levels hit the targeted
goal of low micromolar circulating concentrations,
demonstrating that the 80 mg capsule resulted in the blood
levels predicted to achieve therapeutic benefit based on
animal studies. Final analysis of the data will soon
be released but it appears the drug is safe and well
tolerated at the planned 80 mg dose level.