SAN DIEGO--(BUSINESS WIRE)--Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH), the world leader in the development of a new class of small molecule compounds based on endogenous steroid hormones, announced that it is commencing this week a two-stage Phase I/II clinical trial with its oral drug candidate TRIOLEX™ (HE3286) in obese, insulin resistant volunteers. TRIOLEX represents a novel class of insulin sensitizers that the Company believes acts by modulating the anti-inflammatory pathway NF-kappaB. The Phase I/IIa 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 Phase I/IIb study. A 28-day Phase I/IIb study, currently scheduled to begin in the first half 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.
