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Published on 6/16/2006 in the Prospect News Biotech Daily.

Hollis-Eden: Preclinical data promising on anti-inflammatory steroids for lung inflammation

By E. Janene Geiss

Philadelphia, June 16 - Hollis-Eden Pharmaceuticals, Inc. said Friday that data detailing the oral activity of five candidate compounds in preclinical animal models relevant to cystic fibrosis highlight the significant anti-inflammatory activity discovered when each of the five candidate compounds is given orally in mouse models of lung inflammation and septic shock, as judged by reduced levels of pro-inflammatory cytokines such as TNF alpha and IL-6 in lung and blood.

Data also demonstrate the ability of the compounds to significantly limit pro-inflammatory cytokines in vitro, using human whole blood and showcase preliminary work in monkeys suggesting the potential for significant oral bioavailability and activity in primates, according to a company news release.

Studies indicate that none of the compounds is immune suppressive, but rather may actually enhance cellular immune responses, officials said.

Chronic inflammation of the lungs is a significant factor in the damaging effects of cystic fibrosis.

Hollis-Eden said its class of compounds has demonstrated anti-inflammatory effects in early clinical studies in HIV and AIDS patients and anti-mycobacterial activity in preclinical models of tuberculosis.

The company said it believes that these anti-inflammatory and immune-stimulating properties of its Hormonal Signaling Technology Platform may contribute to a decrease in the chronic lung inflammation associated with cystic fibrosis and limit and prevent pulmonary infections in cystic fibrosis patients.

The company said it plans to compare the five compounds, which include candidates identified through Hollis-Eden's internal structure-activity relationship study program profiling second-generation compounds in a number of therapeutic categories, in preclinical toxicity studies as well as additional efficacy studies in order to arrive at the optimal compound for continued clinical development.

Beginning the toxicity studies will be a milestone under Hollis-Eden's collaboration with Cystic Fibrosis Foundation Therapeutics, Inc., the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation, resulting in a payment from the foundation to Hollis-Eden, officials said.

The preclinical results were presented at the 29th European Cystic Fibrosis conference being held in Copenhagen, Denmark.

Hollis-Eden is a San Diego biopharmaceutical company developing a proprietary new class of small molecule compounds that are metabolites or synthetic analogs of adrenal steroid hormones.


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