Healthcare Industry News:  E2100 

Biopharmaceuticals FDA

 News Release - June 8, 2006

Hollis-Eden Pharmaceuticals Announces FDA Clearance to Commence Human Clinical Study with NEUMUNE in Patients at Risk of Healthcare-Associated Infections

SAN DIEGO--(HSMN NewsFeed)--June 8, 2006--Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH ) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase I/II dose ranging human clinical trial with its investigational compound NEUMUNE(TM) (HE2100) in patients at high risk of developing healthcare-associated (nosocomial) infections. Hollis-Eden's goal in this trial will be to establish the safety of NEUMUNE in this population, and to help identify the optimal patient subsets for further study in Phase II efficacy trials.

Healthcare-associated infections present a major problem for patients who are immune suppressed as a result of illness, injury, advanced age, or the stress of hospitalization. Approximately two million people contract healthcare-associated infections each year in the United States, leading to an estimated 90,000 deaths annually. Due to the emergence of drug resistant strains of bacteria, many hospital infections can no longer be treated effectively with commonly used antibiotics. In the United States alone, the healthcare costs associated with these infections exceed $4.5 billion annually.

Pursuing healthcare-associated infections as a therapeutic application for NEUMUNE is a natural progression from Hollis-Eden's development program for Acute Radiation Syndrome (ARS), a condition that can increase an individual's susceptibility to life-threatening infections and risk of bleeding. In this program, NEUMUNE has been evaluated in studies in healthy and radiation-induced immune suppressed rhesus monkeys and in Phase I clinical studies in healthy human subjects. Results from these studies suggest NEUMUNE may have activity that could protect immune suppressed individuals from healthcare-associated infections through stimulation of innate immunity -- the body's first line of defense.

More specifically, these results demonstrate that NEUMUNE treatment stimulates formation of bone marrow precursor cells that in turn lead to an increase in key components of the innate immune system, including neutrophils and platelets. Neutrophils are infection-fighting white blood cells that play a role in the body's immune response to bacteria. Platelets are blood clotting elements that have now been reported in published studies to interact with neutrophils as key components of host immune defense. In irradiated monkeys, this stimulation of innate immunity translated into increased survival compared to placebo-treated monkeys in a model where clinical support was not provided, as well as decreased episodes of fever and antibiotic use in a model where clinical support was provided. In Phase I human studies conducted to date, NEUMUNE has been well tolerated, with irritation due to the injection being reported as the most common adverse event.

NEUMUNE also has demonstrated an anti-inflammatory and an anti-infective activity in a number of in vivo preclinical models of a variety of viral and bacterial infections characteristic of the types of infections typically found in patients with healthcare-associated infections.

"Receiving FDA clearance to initiate the first clinical study with NEUMUNE in the setting of healthcare-associated infections is a significant step forward for Hollis-Eden as we seek to expand our market opportunities for our Hormonal Signaling Technology Platform," stated Richard Hollis, Chairman and CEO of Hollis-Eden Pharmaceuticals. "Having demonstrated in other indications the ability of our compounds to stimulate host immunity to increase resistance to disease and infections, we are enthusiastic about the potential of developing NEUMUNE for this significant unmet medical need."

Hollis-Eden Pharmaceuticals, Inc. is developing a proprietary new class of small molecule compounds that are metabolic conversion products or synthetic analogs of adrenal steroid hormones. These compounds, 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, 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. 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

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 ability to complete preclinical and clinical trials successfully and within specified timelines, if at all; the ability to obtain regulatory approval for NEUMUNE under the U.S. Food and Drug Administration Animal Efficacy Rule, even if shown to be effective in preclinical studies; the ability to receive any stockpiling orders for NEUMUNE from the U.S. federal, state and foreign governments, even if approved by regulatory authorities; the Company's future capital needs; the Company's ability to obtain additional funding; the ability of the Company to protect its intellectual property rights and to not infringe the intellectual property rights of others; 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.

Source: Hollis-Eden Pharmaceuticals

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