Sep. 10, 2002
Hollis-Eden Pharmaceuticals, Inc. today announced publication of results demonstrating that investigational immune regulating hormones HE2200 and HE2500 delay, limit or completely prevent disease in Experimental Allergic Encephalomyelitis (EAE), a well-accepted preclinical model that mimics multiple sclerosis in humans. The data are reported in the September issue of The Journal of Neuroimmunology. The lead author of the paper is Dr. Halina Offner, Professor of Neurology at Oregon Health & Science University.
Results reported from the experiments demonstrated that animals injected with either subcutaneous HE2200 or HE2500 dramatically delayed disease onset, reduced severity and limited relapses when compared to the placebo treated animals. Benefit was associated with the reduction of inflammatory cells in the brain and with decreases in autoimmune T-cell responses. Both HE2200 and HE2500 have shown encouraging activity in preclinical models of a number of autoimmune diseases, and both compounds are also currently being studied in separate Phase II clinical studies for cardiovascular disease. The compounds to date have been generally well tolerated in clinical trials.
The EAE model mimics many of the same pathology associated with the progression of multiple sclerosis by inducing inflammatory T-cells that attack the protective myelin sheath in the brain and spinal cord. This same model was used in the development of Beta Interferon, a currently approved treatment for multiple sclerosis. The experimental model measures the physical characteristics associated with the disease onset and progression, which include the relapsing and remitting symptoms associated with multiple sclerosis-like disease. Further, the model correlates disease patterns with the over expression of pro-inflammatory gene expression and associated cytokines.
Hollis-Eden has licensed HE2200 from Dr. Roger Loria, a professor at Virginia Commonwealth University, and a noted expert in immune regulating hormones. HE2500 is being developed by Aeson Therapeutics, Inc. Hollis-Eden holds an equity interest in Aeson and has an option to acquire the remainder of the company at a predetermined price.
"I'm very excited by these preclinical findings," said Dr. Halina Offner. "We are starting to understand and appreciate the differences in potency and safety between this class of hormones and other steroid hormones previously studied for autoimmune conditions such as multiple sclerosis. We are anxious to conduct additional work with this potentially important new class of materials with the ultimate goal of translating these findings into beneficial effects for patients who are badly in need of additional treatment options."
"We are pleased to see the publication of these study results in a prestigious, peer reviewed publication such as the Journal of Neuroimmunology," said Richard Hollis, Chairman and CEO of Hollis-Eden Pharmaceuticals. "This publication builds on an impressive body of studies showing the important potential effects of immune regulating hormones in a variety of disease settings. It is becoming increasingly clear that targeting the underlying cellular pathways implicated in immune dysfunction with our novel class of steroid hormones may benefit patients suffering from a wide variety of immune system disorders by reestablishing the proper cellular signals necessary for a more homeostatic immune profile. We look forward to further developing this class of compounds in clinical settings of autoimmunity."
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 (IRH's). 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 for HIV/AIDS, malaria and hepatitis B. 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 cholesterol lowering. In addition, the Company 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 with HE2500 for the treatment of hypertriglyceridemia. 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, the ability to acquire Aeson Therapeutics 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.
CONTACT: Hollis-Eden Pharmaceuticals, San Diego
Dan Burgess, 858/587-9333, ext. 409
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