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Hollis-Eden Announces Grant Awarded by the Office of Naval Research to Study HE2200 In the Treatment of Traumatic Shock.

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SAN DIEGO--(BUSINESS WIRE)--Feb. 3, 2003

Hollis-Eden Pharmaceuticals, Inc. (Nasdaq:HEPH) today announced the Office of Naval Research awarded Dr. Roger M. Loria, at Virginia Commonwealth University's Medical College of Virginia, a preclinical research grant in the amount of $430,000 to study the effects of Hollis-Eden's immune regulating hormone, HE2200, for the treatment of traumatic shock. The Virginia Commonwealth University Reanimation Engineering Shock Center (VCURES: http://www.vcures.org/) will also participate in this collaborative study.

The three specific goals of the preclinical research in models of traumatic shock will be to examine the ability of HE2200 to (1) modulate the immune and inflammatory response systemically and in multiple organ systems, (2) preserve microcirculatory flow and tissue oxygenation and (3) improve survival. Suppression of the immune system following traumatic shock is a major factor contributing to the development of infection. These inflammatory or infectious complications have been estimated to be responsible for as much as 60% of deaths from trauma in the civilian population. This high mortality rate after trauma highlights the importance of mediating the relationship between stress response and immune suppression.

Previous preclinical work by Dr. Loria's laboratory has suggested that immune regulating hormones such as HE2200 may confer protection against a wide range of infectious agents by modulating immune function. These studies have also demonstrated that HE2200 is particularly effective when stress is a complicating factor in the injury. This grant will allow researchers to evaluate the ability of HE2200 to reduce mortality and improve immune function after traumatic injury. The primary objective of this research for the military is to determine if HE2200 might be beneficial if given with initial resuscitation fluids to prevent immune dysfunction that is associated with later development of infections and death following trauma in the battlefield.

Immune suppression and dysregulation is believed to be a fundamental factor underlying the pathology of many of the conditions being targeted by Hollis-Eden in developing immune regulating hormones. In addition to the role of these factors in trauma described above, loss of immunity is a critical component in the damage caused by acute radiation injury and chemotherapy. Immune dysfunction is also integrally linked to a number of infectious diseases such as HIV, malaria and tuberculosis, as well as to a wide variety of pathogenic organisms that are feared will be used in biowarfare. Hollis-Eden has development programs in all of these areas with its immune regulating hormones, and preclinical and early clinical studies indicate the compounds appear to help the immune system to re-regulate towards homeostasis in a variety of conditions of immune suppression and dysregulation.

Dr. Loria is Professor of Microbiology and Immunology at VCU and is the project's principal investigator. Dr. Loria is a leading expert in the field of immune regulating hormones and is a scientific collaborator for Hollis-Eden. He is joined in this collaboration by the following investigators at VCURES: R. Wayne Barbee, Ph.D., Assistant Professor of Emergency Medicine and Physiology; Kevin R. Ward, MD, Assistant Professor of Emergency Medicine and Physiology; and Rao R. Ivatury, MD, Professor of Surgery and Emergency Medicine and Division Chair of Trauma Surgery and Surgical Critical Care.

"It is now appreciated that trauma may also result in early and protracted suppression of the host immune response," stated Dr. Ward. "This suppression, although not affecting immediate survival, is believed to be a major factor portending the development of post-resuscitation complications such as sepsis, multisystem organ failure and death, which have a multimodal distribution of occurrence after the initial insult. The relationship and link between post-traumatic immune dysfunction and microcirculatory tissue oxygenation on a whole body basis has not been studied extensively, and enhancing tissue oxygenation by modulating the immune system may be key in improving survival."

"Previously, we have been very limited in what could be offered in the `golden hour' of care that would produce long-term benefits during the days to weeks of recovery following the initial injury," stated Dr. Ivatury, who is also the current president of the Pan American Trauma Society. "In terms of military operations, the paradigm is even more complex, since wounded soldiers and their caregivers really do not have a `golden hour' in which to work."

This study utilizes a unique model of injury and treatment that is intended to mimic as closely as possible both the injury and treatments provided in traumatic shock. "A shortcoming of many preclinical studies of new treatments for shock that have shown promise but have later failed in clinical studies is that these preclinical studies have not taken into account very important factors of the injury as well as treatments, both of which can have a profound effect on the immune system," said Dr. Barbee.

"We have reported that immune regulating hormones offer a potential weapon against conditions associated with immune suppression and dysregulation resulting from trauma, hemorrhage and sepsis," said Dr. Loria. "A reduction in mortality with HE2200 in this model system of traumatic hemorrhagic shock would justify clinical trials in traumatic shock."

"We congratulate Dr. Loria and his colleagues at VCURES for being awarded this grant to study HE2200 in trauma," said Richard Hollis, Chairman and CEO, Hollis-Eden Pharmaceuticals. "It is well known that VCU's Medical College of Virginia is one of our country's most prestigious and respected trauma centers. We are also pleased to be further expanding the potential role immune regulating hormones can play in both protecting our military personnel as well as civilians as part of Homeland Defense. In addition to this collaboration with the Office of Naval Research on the use of HE2200 for trauma, we are also collaborating with the Armed Forces Radiobiology Research Institute on developing another immune regulating hormone, HE2100, for use in protection against acute radiation injury and have also recently entered into an agreement with the Walter Reed Army Institute for Research to test HE2000 and other immune regulating hormones against a number of biowarfare pathogens and infectious diseases. Given the current geopolitical instability, the need for broad-spectrum new drugs that can enhance host immunity has never been greater. We believe President Bush's recently announced Project Bioshield Initiative, combined with new legislation introduced in Congress to spur innovation in this area, highlights the critical new role biotechnology can play in national defense. Because we have been focused for a number of years on how immune regulating hormones can enhance host immunity, we have been able to move several of these compounds into advanced development and clinical trials and, as a result, are now fortunate to be in a leadership position in this important new area of medicine. We also believe these findings may translate into many other medical uses and commercial opportunities."

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 currently being studied in clinical trials in a number of infectious diseases. In addition, Hollis-Eden recently 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 an additional IRH, 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 Web site 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 preclinical and 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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