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news.Hollis-Eden Pharmaceuticals says initial results from its ongoing single-dose Phase I study of HE3286 for the treatment of type II diabetes demonstrate the compound is orally bioavailable in humans, with significant drug concentrations detected in the blood at the lowest dose tested.
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The company’s findings also show that all doses of HE3286 (10mg to 100mg) appear to be safe and well tolerated in healthy volunteers with no reported drug related adverse side effects to date.
Hollis-Eden believes these initial results from the ongoing Phase I clinical study with HE3286, combined with continued positive data in animal models of autoimmune conditions, bodes well as it plans to file in the third quarter of 2007 an additional investigational new drug application for treating inflammatory conditions.
A Phase I/II clinical trial of HE3286 is planned in rheumatoid arthritis patients for the fourth quarter of 2007, as is a separate multi-dose Phase I study of HE3286 for metabolic disorders under the company’s open IND.