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Hollis-Eden Pharmaceuticals Presents Anti-Inflammatory Effects of HE2500 in Preclinical Model of Psoriasis; Data Presented At Third International Congress On Autoimmunity.

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SAN DIEGO--(BW HealthWire)--Feb. 21, 2002

Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) today announced positive results from a preclinical study of HE2500, an immune regulating hormone, in an animal model of psoriasis. Highlights from the study indicated that by week four, disease severity in mice receiving high dose HE2500 was reduced to mild or absent compared to the severity observed in mice receiving placebo alone (moderate to severe). The results are being presented in a poster session at the Third International Congress on Autoimmunity being held this week in Geneva, Switzerland.

Animals selected for the psoriasis study had moderate to severe disease as measured by ear thickness. The study design called for the animals to be injected once daily with either HE2500 or placebo starting after the animals developed clinical symptoms and continued daily thereafter for four weeks. Ear thickness was measured twice weekly. Within two weeks of treatment ear thickness was significantly reduced in the HE2500 treated animals compared to placebo. By week four of treatment, disease severity in the animals receiving HE2500 was reduced to mild or absent compared to moderate to severe disease in animals treated with placebo. These results were statistically significant at both the two- and four-week time points. The study demonstrates that HE2500 significantly reduced ear thickness in a psoriatic preclinical model and provides preclinical justification for the use of the compound in human clinical trials.

The Company is planning to initiate a Phase II clinical trial in psoriasis in 2002. Psoriasis is estimated to affect approximately seven million people in the United States. While there is no cure for psoriasis, there are several treatments available that are prescribed according to the specific disease characteristics of the individual patient. These treatments include topical and systemic steroids, oral and topical retinoid therapies, vitamin-D analogs, phototherapy, photochemotherapy, and moisturizers. While these therapies and newer biological approaches being developed have provided relief to psoriasis patients, industry research indicates that limitations with these approaches provide a significant opportunity for new safe, efficacious and cost-effective therapies.

"This data further validates the anti-inflammatory properties of our unique class of immune regulating hormones," said Richard Hollis, Chairman and CEO of Hollis-Eden Pharmaceuticals. "We continue to demonstrate the role these compounds may play in autoimmune conditions. Last November we reported data from several clinical and preclinical studies demonstrating the anti-inflammatory properties of HE2000 and HE2200. Corticosteroids are widely used to treat a number of autoimmune conditions, including psoriasis. Market research indicates that there were 67 million new prescriptions for corticosteroids written in the United States last year. Immune regulating hormones such as HE2500 have been shown in preclinical models of a number of autoimmune diseases to reduce inflammation in a manner similar to that historically seen with corticosteroids. Unlike corticosteroids, however, rather than causing immunosuppression, immune regulating hormones have been shown in both preclinical as well as early clinical trials to boost immune responses in conditions of immune suppression."

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. The Company has access to HE2500 through its relationship with Aeson Therapeutics. HE2500 is also currently being studied in Phase II clinical trials in cardiovascular disease and actinic keratosis. The Company's lead investigational drug HE2000 is currently being studied in clinical trials for HIV/AIDS in South Africa. In addition, 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. The Company is also conducting a Phase I clinical trial in the United States with another of its immune regulating hormones, HE2200. 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). For more information on Hollis-Eden, contact the Company's website at www.holliseden.com.

Statements made in this press release may constitute forward-looking statements and are subject to numerous 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.
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Publication:Business Wire
Date:Feb 21, 2002
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