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Hollis-Eden Pharmaceuticals Presents Data Correlating Hormone Structure to Specific Immune Regulating Activity

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May 6, 2003
Business Editors/Health/Medical Writers
Business Wire
San Diego

Hollis-Eden Pharmaceuticals, Inc. today announced data demonstrating, for the first time, the relationship between the chemical structure of specific immune regulating hormones (IRH's) and their ability to regulate inflammation associated with either cell or antibody mediated immune responses. Data was presented today at the 90th Anniversary Meeting of The American Association of Immunologists, being held May 5 - 9, 2003 in Denver, Colorado.

New preclinical findings presented from studies conducted with immune regulating hormones indicate that specific chemical modifications of hormone structure lead to desired immune regulation. The data was produced from an assay in which immune regulating hormones are injected into the footpad of a mouse. Seven days later, the lymph node is queried with respect to cell numbers and types (T-cells, dendritic cells, B-cells), cytokines and antibody production. The results from these studies showed that different arms of the immune system (cell versus antibody mediated immunity) could be regulated depending on the structure of the IRH injected. This is the first clear demonstration that specific chemical modifications of immune regulating hormone structure can regulate different aspects of the immune system.

In conjunction with these findings, supporting preclinical data in an experimental model of multiple sclerosis and clinical data from separate clinical studies conducted in HIV and malaria-infected patients was reviewed. Taken together, these studies suggest that specific immune regulating hormones may provide benefit to patients with infectious, inflammatory and autoimmune mediated diseases.

"This is a significant scientific advancement for the Company because it provides us with an important new tool to differentiate the activities of our compounds on the immune system," stated James M. Frincke, Ph.D., Chief Scientific Officer, Hollis-Eden Pharmaceuticals, Inc. "We know that small chemical changes in these molecules can lead to very significant changes in biological activity. We believe this model system enables us to clearly segment the specific component of the immune system each of our compounds is affecting, allowing us to more effectively target each compound to the appropriate indication. It also allows us to test second-generation compounds so that we can continue to develop this exciting new class of pharmaceutical agents for additional indications."

"We have previously demonstrated that our class of immune regulating hormones could limit non-productive inflammation and restore immune function," stated Richard Hollis, Chairman and CEO, Hollis-Eden Pharmaceuticals, Inc. "We are pleased that our scientists are presenting this data, educating the scientific community about the structure function relationships of our drug candidates. Our vision continues to be that by correcting underlying immune dysregulating with this important class of immune regulating hormones, we will have the opportunity to address some of the most challenging, unmet medical needs of the 21st century."

Hollis-Eden Pharmaceuticals, Inc. is a development-stage pharmaceutical company based in San Diego, California, working to become the world leader in the development of a new class of investigational drugs known as Immune Regulating Hormones (IRHs). The goal of IRH therapy is to direct, through controlling gene expression, the production of key cytokines and enzymes that re-regulate immune and metabolic functions toward homeostasis, a profile that could be useful in a wide variety of diseases. The Company has a number of investigational IRHs under development, including HE2000, which is being studied in a number of infectious diseases. In addition, Hollis-Eden has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Department of Defense to jointly develop another IRH, HE2100, as a radioprotectant (a drug that may potentially be used to protect a person from radiation injury due to a nuclear accident or event). Hollis-Eden is also developing HE2200 for improving vaccine responses in the elderly and for lowering cholesterol in conditions of hypercholesterolemia. For more information on Hollis-Eden, contact the Company's website at http://www.holliseden.com/

This press release contains forward-looking statements concerning the potential and prospects of the Company's drug discovery program and its drug candidates. Any statement describing a goal, expectation, intention or belief of the Company is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including the failure to successfully complete clinical trials, the Company's future capital needs, the Company's ability to obtain additional funding and required regulatory approvals, the ability of the Company to protect its intellectual property rights and to not infringe the intellectually property rights of others, the development of competitive products by other companies and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. The actual results may differ materially from those contained in this press release.
 

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