Hollis-Eden Pharmaceuticals Describes New Data with Potent Second Generation Immune Regulating Hormones in Preclinical Models of Autoimmune and Inflammatory Conditions.

SAN DIEGO -- Findings Presented at The Fourth International Congress on Autoimmune Diseases, Budapest, Hungary

Hollis-Eden Pharmaceuticals, Inc. (Nasdaq:HEPH) announced today that it is presenting new data this week on the potential role of immune regulating hormones (IRHs) in treating a variety of autoimmune and inflammatory conditions. The data includes results from a number of in vitro and in vivo preclinical studies with both first generation and more potent second generation investigational IRH compounds. The presentations are being made at the Fourth International Congress on Autoimmune Diseases in Budapest, Hungary by a combination of Hollis-Eden scientists and independent scientific investigators who have worked with Hollis-Eden's compounds. These new findings are being featured in a series of oral presentations devoted specifically to IRHs in a session titled the Therapeutic Potential of Immune Regulating Steroids as Treatment for Autoimmunity.

First generation immune regulating hormones have been shown in preclinical and early clinical studies to provide broad-spectrum anti-inflammatory activity. These small molecule drug candidates are structurally similar to widely used corticosteroids, but unlike corticosteroids they do not appear to cause immune suppression or bone loss--two common side effects of corticosteroids. In the studies presented at this meeting, striking anti-inflammatory effects were seen with IRHs in in vivo models of pleurisy (a model of lung inflammation), EAE (experimental autoimmune encephalomyelitis, a model of multiple sclerosis) and LPS challenge (lipopolysaccharide, a lethal model of endotoxic shock). In addition to these anti-inflammatory properties, IRHs were shown to improve immune function (rather than suppress it as would be expected with corticosteroids) in a popliteal lymph node assay and were also shown to counteract corticosteroid-induced changes responsible for bone loss in in vitro studies. Compounds profiled in one or more of these studies included first generation IRHs as well as a series of more than 10 new second generation IRHs that were able to demonstrate more potent activity than the first generation IRHs.

"We are excited about this continuing progress in our autoimmune program," said Dr. James Frincke, Chief Scientific Officer of Hollis-Eden Pharmaceuticals. "Not only does it demonstrate the significant advances we are making in understanding the metabolism and structure-activity relationships within this class of compounds, we also believe it will significantly broaden and enhance our intellectual property position in this space. More importantly, we believe this data provides important support for advancing one or more of our second generation IRHs into clinical trials in autoimmunity. This is an exciting new class of high potency steroidal anti-inflammatory agents with the potential to address a variety of autoimmune disorders."

"What is striking about these findings," said Dr. Ferdinando Nicoletti, Professor of Medicine at the University of Catania, Italy, "is that Hollis-Eden's new compounds provide benefit at a much lower dose than needed with first generation Hollis-Eden compounds tested in the past." Dr. Nicoletti, a widely known expert on preclinical models of autoimmunity, is Co-Chair of the session on IRHs at the meeting.

"We are delighted that, for the first time, immune regulating hormones are taking center stage in a session at a major international autoimmune meeting," said Richard Hollis, Chairman and CEO of Hollis-Eden Pharmaceuticals. "The identification of more potent second generation compounds remains a key goal for the Company, and we are also pleased that these discoveries may provide the Company with significant new intellectual property and market opportunities. While our primary focus remains on developing and commercializing NEUMUNE(TM) for protection against Acute Radiation Syndrome because of the accelerated development timeframes that are potentially available for countermeasures to weapons of mass destruction, we continue to believe that, over the longer term, there is an enormous opportunity for our IRHs in the area of autoimmunity. A cost-effective new class of therapeutics that could reduce inflammation without causing immune suppression or bone loss would be an important medical advance for patients suffering from a wide range of devastating autoimmune conditions. Based on the data presented at this and previous scientific meetings, we believe our immune regulating hormones have the potential to fulfill this promise and play a major role in treating conditions of inflammation, autoimmunity and diseases of the aging."

Hollis-Eden Pharmaceuticals, Inc. is a development-stage pharmaceutical company based in San Diego, Calif., 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 compounds under development, including NEUMUNE, which the Company is developing for use in protection from acute radiation syndrome (ARS); PHOSPHONOL(TM), a non-IRH candidate for providing protection against DNA mutations from radiation exposure and chemotherapy treatment; and IMMUNITIN(TM), which has shown activity in a variety of infectious diseases, including HIV/AIDS, tuberculosis and malaria. Hollis-Eden is also developing IRHs for protection from chemotherapy and other conditions of immune dysregulation. For more information on Hollis-Eden, contact the Company's website at 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 ability to successfully complete preclinical and clinical trials within specified timelines, if at all; the ability to obtain regulatory approval for NEUMUNE, even if shown to be effective in preclinical studies; the ability to receive any stockpiling orders for NEUMUNE from the U.S. and foreign governments, even if approved by regulatory authorities; the Company's future capital needs; the Company's ability to obtain additional funding; the ability of the Company to protect its intellectual property rights and to not infringe the intellectual 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.