Hollis-Eden Pharmaceuticals Presents Positive Data with HE3286 in Preclinical Model of Established Rheumatoid Arthritis.

Effect Linked to the Stimulation of Regulatory T Cells 

SAN DIEGO -- Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) is presenting new data this week showing that HE3286, an orally bio-available small molecule compound, produced a statistically significant reduction in disease in a rodent model of established arthritis. The data, being presented at the Keystone Symposium on Regulatory T Cells held February 1 - 6 in Vancouver, British Columbia, extend positive results from a previous preclinical study in which treatments of HE3286 initiated at disease onset significantly reduced disease. In that previous study, treated animals had nearly double the frequency of regulatory T cells in their spleens at the end of the 50-day study, suggesting that treatment with androstene hormones such as HE3286 can modulate the function and frequency of regulatory T cells in animals. Regulatory T cells have been shown to play major roles in the control of all immune responses. Specifically, deficiencies in regulatory T cell activity are thought to play a crucial role in the development of many autoimmune diseases, including arthritis and multiple sclerosis.

At the Keystone Symposium, Hollis-Eden is presenting new data showing that when treatments begin late in the disease course, HE3286 can still produce dramatic reductions in disease. Mice were immunized to induce disease, and one week after disease onset were treated orally with HE3286 or placebo. While the severity of arthritis worsened steadily in the placebo-treated group, it nearly resolved or remained at a minimum in the HE3286-treated group (p < 0.001). Treatment resulted in a difference in arthritis severity that was on average 45% lower in the HE3286-treated group than in the placebo-treated group. The study was conducted in the DBA mouse model of collagen-induced arthritis, a model widely used in industry and academia to test new agents as potential treatments for rheumatoid arthritis. Rheumatoid arthritis affects approximately 2.1 million Americans and new drugs with novel mechanisms are needed.

"We continue to be impressed by the activity of HE3286 in our animal models," said Dr. Halina Offner, Professor of Neurology at Oregon Health Science University and an expert on animal models of autoimmune diseases. "We have now confirmed and extended our previous findings with this compound in rodent models of arthritis where we observed the number of regulatory T cells nearly doubled in the treated animals - an immunologically significant finding in this model. Our group at OHSU was particularly excited by our newest study, where dramatic benefit was observed even when the treatment of animals was delayed until late in the course of their disease. We want very much to test this compound now in other models of autoimmunity because the stimulation of regulatory T cell activity predicts that benefit should be seen across a number of autoimmune conditions."

"We are particularly excited by Dr. Offner's new observations with HE3286 in models of rheumatoid arthritis," said Richard B. Hollis, Chairman and Chief Executive Officer of Hollis-Eden Pharmaceuticals. "The ability to treat established disease in this indication is highly clinically relevant. Also important is the broader implication that androstene hormones in general might be natural regulators of regulatory T cells. We have developed collaborations with world-renowned experts to help us pursue this opportunity and test the intriguing hypothesis that the regulatory T cell represents one of the key relay points of our hormone signaling technology platform.

"These findings further demonstrate the potential of our technology platform from which we intend to launch multiple, potentially first-in-class compounds with therapeutic activity in a broad range of indications including infectious diseases, autoimmune and metabolic disorders, cancer and other diseases associated with aging," added Hollis. "As world leaders in translating this class of androstene hormones into pharmaceutical candidates, our objective is to provide patients and physicians with therapeutic options with unique mechanisms of action and favorable safety profiles in major disease markets."

Hollis-Eden Pharmaceuticals, Inc. is a world leader in the development of a class of adrenal steroid hormones as novel pharmaceuticals for human health. Through its proprietary Hormonal Signaling Technology Platform, Hollis-Eden is developing a new series of small molecule compounds that are metabolites or synthetic analogs of endogenous hormones derived by the adrenal glands from the body's most abundant circulating steroid. These androstene hormones, designed to restore the biological activity of cellular signaling pathways disrupted by disease and aging, have been demonstrated in humans to possess several properties with potential therapeutic benefit - they regulate innate and adaptive immunity, reduce nonproductive inflammation and stimulate cell proliferation. The Company's lead product candidate, NEUMUNE[R] (HE2100), is entering late-stage development for the treatment of Acute Radiation Syndrome (ARS), a life-threatening condition resulting from exposure to high levels of radiation following a nuclear or radiological incident, and is being explored for use in combating healthcare-associated infections. Hollis-Eden also is profiling optimized second-generation compounds for potential clinical development in a broad spectrum of therapeutic categories including hematology, metabolic disorders, autoimmune disorders, pulmonary diseases, oncology and infectious diseases. For more information on Hollis-Eden, contact the Company's website at www.holliseden.com.

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