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Hollis-Eden to Present Interim Data From Its Phase I/II Clinical Studies of Apoptone(R) (HE3235) at Molecular Targets and Cancer Therapeutics Conference
Date:11/12/2009

age with potential corporate partners for the design and funding of late-stage development programs in diseases with high unmet medical need."

Triolex Clinical Program Update

Diabetes

Pre-diabetes Phase I safety tolerance and early activity trial HE3286-0102

This study has completed the planned enrollment of 48 patients and data analysis has been initiated. Preliminary results indicated that Triolex was safe and well-tolerated, and there were no side effects observed such as those seen with testosterone, estrogen, progesterone or glucocorticoids.

Diabetes Phase II two-stage exploratory and confirmatory trial HE3286-0401

This ongoing study in type 2 diabetic patients was undertaken based on promising Triolex activity in insulin-resistant, prediabetic subjects. The original study began in the second half of 2008. The initial exploratory phase included 84 days of treatment with Triolex or placebo along with metformin in patients with uncontrolled HbA1c levels. Activity was found in a subset of diabetics defined with biomarkers as obese, inflamed and insulin-resistant. A confirmatory, placebo-controlled trial was initiated in the second quarter of 2009 in patients dosed only with Triolex or placebo in order to avoid potential confounding effects of metformin on anti-inflammatory activity. The confirmatory stage of the trial is fully enrolled; the last patient is expected to complete the trial in the first quarter of 2010.

Other Inflammatory Diseases

Two exploratory Phase I/II studies were initiated with Triolex in other diseases with an auto-immune inflammatory etiology. The results of these studies, combined with our completed non-clinical long-term toxicology data, will permit proof-of-concept trials in these indications as resources become available.

Ulcerative colitis Phase I/II safety, tolerance and early activity tria
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SOURCE Hollis-Eden Pharmaceuticals, Inc.
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