Hollis-Eden Pharmaceuticals Announces HE2200 Significantly Increases Survival in Preclinical...

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SAN DIEGO--(BW HealthWire)--July 22, 2002

Hollis-Eden Pharmaceuticals, Inc. (Nasdaq:HEPH) today announced the presentation of results indicating that its investigational immune regulating hormone, HE2200, significantly

increased survival in a mink model of experimental Aleutian disease virus (ADV), a preclinical model of fatal lupus nephritis. The study's lead investigator, Dr. Dale Barnard, research associate professor at the Institute for Antiviral Research, Utah State University, presented the data this past weekend at the 21st annual meeting of the American Society of Virology in Lexington, Kentucky.

The study was designed to evaluate the effects of HE2200 on 25 virally infected animals, which normally progress to exhibit a severe lupus-like disease. During the study, 15 animals received HE2200 by subcutaneous injection three times per week at doses ranging from 1.6 to 100 mg per day. At the end of the 16-week study, all 15 of the HE2200 treated animals had survived and only 1 of the 10 untreated animals survived. During the 13-week follow up, 13 of the 15 treated animals survived, while the one remaining untreated animal did not survive the follow up period. Additional results from the experiment included reduction in the treated animals, relative to untreated animals, of virus specific antibodies, which are implicated in the glomerulonephritis characteristic of ADV; and significantly less weight loss (wasting) in the HE2200 treated animals than in the untreated animals. The drug was well tolerated in the study.

"The striking survival advantage seen in these preclinical results is very encouraging for supporting basic research to determine the efficacy of the compound as a potential therapeutic agent for treating immune complex diseases of humans," Dr. Barnard said.

"This study, combined with our preclinical findings in other autoimmune diseases such as psoriasis, arthritis, multiple sclerosis and inflammatory bowel disease, is rapidly expanding our knowledge base for the development of effective treatments for indications where inflammation, hormonal imbalances and dysfunctional immune systems are implicated," stated Richard B. Hollis, Chief Executive Officer of Hollis-Eden. "In all autoimmune diseases, the underlying cause is the same -- the body's immune system, which, under normal conditions, controls the body's defenses against infections from outside the body, mistakenly attacks itself, targeting the cells, tissues and organs from within. In the resultant T cell-dependant response, antibodies known as autoantibodies are produced, and these attack host antigens, causing inflammation and immunological damage to tissues where these antigens occur. Therefore, in diseases of inflammation, current treatment modalities involve using anti-inflammatory agents to decrease inflammation and tissue damage. Hollis-Eden's goal is to regulate immune responses and decrease inflammation without causing the side effects typically associated with currently approved drugs."

Hollis-Eden Pharmaceuticals, Inc. is a development-stage pharmaceutical company based in San Diego, California, engaged in the development of products for the treatment of infectious diseases and immune systems disorders. The Company's vision is to become the world leader in immune regulating hormones and their application to numerous diseases. HE2000 is the Company's lead investigational drug and is currently being studied in clinical trials for HIV/AIDS in South Africa. Hollis-Eden is also conducting a Phase I/II clinical trial with HE2000 in the United States in HIV infected patients failing at least their second antiviral drug regimen. Phase II studies in Thailand are also being conducted with HE2000 in the treatment of malaria, and in Singapore for the treatment of hepatitis B. In addition, Hollis-Eden recently entered into a Cooperative Research and Development Agreement (CRADA) with the United States Department of Defense to develop 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 recently announced the initiation of a Phase I/II clinical trial with HE2200 for vaccine potentiation in elderly patients receiving a hepatitis B vaccine. The Company also has an option to acquire intellectual property rights to HE2500 through its relationship with Aeson Therapeutics, Inc. Aeson is currently conducting Phase II clinical trials of HE2500 for the treatment of cardiovascular disease. 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 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 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.