Hollis-Eden Pharmaceuticals, the world leader in the development of a new class of small molecule compounds based on endogenous adrenal steroid hormones, has commenced phase I/II open label dose ranging clinical trial with its investigational oral drug candidate Triolex (HE3286) in patients diagnosed with rheumatoid arthritis (RA) and receiving a stable dose of methotrexate, the current standard of care in RA.

The purpose of the phase I/II clinical trial is to evaluate the safety and tolerance of Triolex, when administered orally for 28 days at three different dose levels. The study will also evaluate the pharmacokinetics (PK) and metabolism profiles of methotrexate and Triolex, when used in combination, and assess any potential anti-inflammatory activity of Triolex.

"The commencement of this clinical trial caps six years of international collaborations with world renowned experts working on the development of a new treatment for RA," commented Dr Dominick L Auci, director of allergy, Autoimmunity and Inflammation at Hollis-Eden Pharmaceuticals. "This body of work, presented over the years at numerous international meetings and published in peer reviewed journals, clearly documents the remarkable activity of Triolex across several animal models of RA, each emphasizing different aspects of the pathophysiology thought to drive the human disease. We are particularly excited to begin this trial because Triolex, without being immune suppressive, has consistently performed as well or better than the biologics in these models and works where methotrexate fails."

Rheumatoid arthritis affects more than 1.3 million people in the United States and is driven by both a cellular and antibody mediated autoimmune response and, as a result, combinations of highly immune suppressive drugs are commonly used to treat both aspects of active disease. Annual sales in the United States of drugs to treat RA are expected to reach $14 billion by 2009, driven by the increase in the aging population and the use of new expensive biological treatments. For instance, Celebrex, a commonly used anti-inflammatory drug for RA that inhibits the cox-2 enzyme currently has annual sales in excess of $2 billion.

Hollis-Eden Pharmaceuticals is a world leader in the development of a proprietary class of adrenal steroid hormones as novel pharmaceuticals for human health. Through its Hormonal Signaling Technology Platform, Hollis-Eden is developing a new series of small molecule compounds that are metabolites or synthetic analogs of endogenous hormones derived by the adrenal glands from the body's most abundant circulating adrenal steroid.