NBMI (N1, N3-Bis-(2-Mercaptoethyl) Isophthalamide) is a new metal chelator drug proposed as
an alternative to the current chelators, and it is widely different; compared to the current
chelators, consisting of two cysteamine molecules coupled to a single molecule of
dicarboxybenzoate. It is used as a chelating agent and has the designation of an orphan drug,
in the EU and USA; in the EU it is used for the treatment of mercury toxicity. It is freely
soluble in solutions of dimethylformamide (DMF), dimethyl sulfoxide (DMSO) and sodium
hydroxide diluted NaOH, slightly soluble in methanol and acetone, and insoluble in water.
Pre-clinical data indicates low to no toxicity, and that it reduces the toxicity associated
with acute exposure to Hg2+.
No other chelator has been reported to prevent acute mercury toxicity with only one exposure
to the chelator. It has the ability to penetrate cell membranes and cross the blood-brain
barrier and chelate Hg2+ in a complex that eliminates the availability of Hg2+ and
essentially eliminates toxic effects. The antioxidant properties of NBMI could also reduce
the toxicity levels of hydroxyl free radicals immediately, upon entering cells suffering from
oxidative stress. It is possible that the combined chelation of Hg2+ and the elimination of
hydroxyl free radicals contribute significantly to the protective effects observed with the
NBMI.
Previous clinical studies conducted in subjects of the Phase I and Phase II a studies
conducted, did not show significant adverse events in patients intoxicated with mercury, all
patients who received the study medication have tolerated it well, with only mild or moderate
adverse events reported; None of these were considered related to the pharmacological
treatment of the study. In addition, there is no potential identified with safety problems in
laboratory tests, or vital signs evaluations.
The purpose of this Controlled Single-Center Double-Blind Crossover Clinical Trial Phase II b
is to determine the efficacy, safety and tolerability of a 14 day 400mg / day of NBMI (N1,
N2-bis-2-mercaptoethyl isophthalamide) Treatment, in the reduction of urinary mercury levels
versus placebo, in accidentally exposed subjects to mercury in Atlántico, Colombia.