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news.Hollis-Eden Pharmaceuticals has initiated a two-stage Phase I/II clinical trial with its novel class of insulin sensitizer, oral Triolex in obese, insulin resistant volunteers.
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Triolex acts by modulating the anti-inflammatory pathway NF-kappaB. The trial is a 28-day study designed to evaluate the safety of the drug candidate and determine the optimal dose for use in a follow-on study.
The study, currently scheduled to begin in the H1 of 2008, will evaluate the effect of Triolex on insulin sensitivity and whole body glucose disposal through euglycemic/hyperinsulinemic clamps, a method widely used in industry and academia to test compounds as potential insulin sensitizers for the treatment of type 2 diabetes.
Richard Hollis, chairman and CEO of Hollis-Eden, said: “Advancing triolex into a Phase I/II human clinical trial is a significant achievement for our development program targeting metabolic disorders.
“Triolex is an analog of a naturally occurring adrenal steroid hormone that we believe may play a role in metabolism, may possess a unique mechanism of action and has demonstrated activity in preclinical models of the disease, we believe the compound, if approved for use, could prove to be an important new class of insulin sensitizers with the potential to be an effective treatment for this chronic, life-threatening disease.”