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news.Hollis-Eden Pharmaceuticals has filed an application with the FDA to begin clinical trials with its drug candidate HE3286 for the treatment of diseases of inflammation. Hollis-Eden plans to initiate a phase I/II clinical trial of HE3286 in rheumatoid arthritis patients during the fourth quarter of 2007.
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Additionally, upon clearance of this IND Hollis-Eden may also consider commencing exploratory studies in the fourth quarter of 2007 to evaluate HE3286 in one or more acute inflammatory conditions, where evidence of activity against well-accepted clinical endpoints could potentially be generated with 28-day dosing.
Hollis-Eden completed a phase I single dose clinical study of HE3286 in healthy volunteers earlier this year for the use of HE3286 in treating metabolic disorders. The findings from that study showed HE3286 to be orally bioavailable in humans and well tolerated with no serious adverse side effects. The Company believes the findings from this previous study will serve to support the initiation of phase I/II clinical studies in patients with rheumatoid arthritis (RA) and other inflammatory conditions.
“If we are successful in developing HE3286, the potential new mechanism of action of this compound may provide an attractive alternative to the current therapeutic options available to patients with inflammatory conditions and autoimmune diseases, since we believe HE3286 will avoid the side effects associated with approved corticosteroid therapies,” commented Richard Hollis, chairman and CEO.