HOLLIS-EDEN GETS EUROPEAN PATENT RIGHTS FOR RADIATION DRUG.

Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH), San Diego, Calif., has received notice from the European Patent Office of the issue of claims that cover the company's leading anti- radiation and chemotherapy protection drug candidates, HE2100 and HE2200. The patent is being granted to Dr. Roger Loria, a professor of Microbiology and Immunology at Virginia Commonwealth University and a recognized leader in the field of immune regulating hormones. Dr. Loria has licensed worldwide rights to HE2100 and HE2200 exclusively to Hollis- Eden. Among other things, the claims specifically cover the use of HE2100 to treat or prevent the side effects of radiation exposure. This patent is expected to cover the use of HE2100 for radiation protection until 2012 in Europe. Patents having similar claims with these compounds have already issued in the United States and are pending in a number of other countries.

In the United States and abroad, there has been an increased concern over the threat of nuclear terrorism and biowarfare. The U.S. government has recently begun stockpiling vaccines for smallpox, antibiotics for anthrax and potassium iodide for long-term cancer risks associated with radiation exposure. However, there are currently no drugs available that are considered appropriate for stockpiling to protect the military, first responders and civilians against the acute effects of radiation injury.

Hollis-Eden is co-developing HE2100 for protection from radiation injury with the Armed Forces Radiobiology Research Institute (AFRRI), an agency within the U.S. Department of Defense, under a Cooperative Research and Development Agreement (CRADA) signed in February 2002. AFRRI has screened thousands of compounds in an effort to find a radioprotectant suitable for widespread use. Out of this screening and profiling effort, HE2100 has emerged as its leading candidate based on its striking efficacy in preclinical models to date, its safety profile and the comparatively low-cost nature of its manufacturing process. AFRRI researchers have published a number of studies indicating HE2100 has the ability to increase neutrophils and platelets and provide dramatic survival benefits in preclinical models of lethal radiation injury. Hollis-Eden and AFRRI have been informed by the U.S. Food & Drug Administration (FDA) that HE2100 would be reviewed for approval under a recently adopted rule for investigational drugs that address situations such as radiation injury, where it would be unethical to conduct efficacy studies in humans. While Phase II and Phase III human clinical trials are normally required for marketing approval of an investigational drug, under the new rule, HE2100 would be considered for approval for this indication based on Phase I safety studies in humans and efficacy in relevant animal species.

Exposure to high levels of radiation can cause a rapid depletion of cells derived from the bone marrow such as neutrophils, granulocytes and platelets that are necessary for controlling life-threatening infections and bleeding episodes. It is this damage to the bone marrow that is responsible for much of the death that occurs in the initial days and months after exposure to high levels of radiation. Other major health risks from radiation exposure include the increased incidence in cancer 10 to 15 years after exposure. Currently, the only drug that is considered appropriate for stockpiling for protection against radiation injury is potassium iodide (KI). KI is useful in protecting the thyroid from the long-term risk of thyroid cancer, but is not useful in protecting against the acute effects of radiation injury and ensuing infections. In Europe, KI has been stockpiled for years in sufficient quantities to treat all civilians living within a number of miles of a nuclear power plant in the event of a nuclear accident. There are currently over 300 nuclear power plants in Europe. Stockpiling of KI has also recently begun for civilians living within 10-50 miles of the 103 active nuclear power plants in the U.S.

"This additional patent allowance in Europe expands our market opportunities and is timely because HE2100 is our leading commercial opportunity and, if approved, could be stockpiled widely," said Richard Hollis, chairman and CEO, Hollis-Eden Pharmaceuticals. "Given the current instability in the world, the risk of weapons of mass destruction being utilized has increased significantly. Clearly, the need for new drugs to protect against the effects of acute radiation injury, whatever the cause, has never been greater. We are working with the U.S. military to develop HE2100 as rapidly as possible and believe it will prove to be an important part of the role biotechnology must play in improving homeland defense with respect to the threat of nuclear terrorism and biowarfare. HE2100 is a member of a class of Immune Regulating Hormones (IRHs) being developed by Hollis-Eden that have shown exciting activity in preclinical and early clinical studies of a number of conditions of immune suppression and dysregulation. We believe IRHs have the potential to become broad-spectrum agents useful against combating diseases of immune dysfunction, whether it is caused by radiation injury, chemotherapy, global infectious pathogens or bioterrorism. Like many others, we believe that the significant resources and governmental initiatives that are now being directed at spurring development of new treatments for the damage that can be caused by agents of mass destruction can also lead to important near-term market opportunities for biotechnology companies and that these development activities will also lead to new treatments for global infectious diseases and cancers. We believe that our work with Immune Regulating Hormones will make us leaders in this important new area of medicine and allow us the privilege of serving our country to defend our soldiers, rescue workers and citizens from acts of terrorism."

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, visit http://www.holliseden.com or call 858/587-9333, ext. 409.