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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

SAN DIEGO, Nov. 12 /PRNewswire-FirstCall/ -- Hollis-Eden Pharmaceuticals, Inc. (Nasdaq: HEPH), will present results of its ongoing human clinical Phase I/II open-label dose-ranging trial with Apoptone® (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC) on November 16 at the American Association for Cancer Research - Molecular Targets and Cancer Therapeutics Conference in Boston. Apoptone, a novel steroid that is an analog of part of the dihydrotestosterone metabolic pathway, stimulates ERK1 signal transduction that counter-regulates PI3K, and thereby initiating tumor cell apoptosis. Apoptone has demonstrated activity in animal models of CRPC, the results of which were recently published in the British Journal of Cancer and the journal Neoplasia.

Concurrently with its lead program Apoptone, Hollis-Eden Pharmaceuticals is pursuing clinical development of a second oral small-molecule candidate, Triolex®, from its synthetic steroid library. Triolex decreases macrophage infiltration into fatty tissues and pro-inflammatory processes. The lead indication for Triolex is Type 2 diabetes. A Phase II trial (HE3286-0401) in obese, insulin-resistant diabetic patients is fully enrolled and should be completed in the first quarter of 2010. A Phase I trial (HE3286-0102) to assess safety and early activity in obese insulin-resistant, pre-diabetic subjects is complete, with final analysis in progress. Additional trials were initiated during 2008 in rheumatoid arthritis (RA) and ulcerative colitis (UC).

James Frincke, Ph.D., Chief Executive Officer of Hollis-Eden Pharmaceuticals commented: "We have reduced our burn rate to enable operations focused on our lead programs to continue into the latter half of 2010. We intend to use data from our ongoing trials to eng
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SOURCE Hollis-Eden Pharmaceuticals, Inc.
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