Hollis-Eden Pharmaceuticals Reports Publication of Results Demonstrating the Ability of Neumune to Increase Survival in a Primate Model of Lethal Radiation Injury
As published in the journal, Hollis-Eden conducted GLP studies in 80 rhesus monkeys exposed to 600 cGy of total body irradiation (TBI) that did not have access to clinical support such as antibiotics, IV fluids and platelet transfusions. In these studies, NEUMUNE intramuscularly administered up to 4 hours after lethal TBI and daily for a total of five days significantly reduced the number of deaths in treated animals. In the placebo group 32.5% of the 40 control animals died, versus only 12.5% of the 40 NEUMUNE-treated animals (p=0.032). Animals receiving NEUMUNE in these studies experienced a statistically significant reduction in the number of days of severe neutropenia (loss of white blood cells that can result in potentially fatal infections) (p less than 0.01) and very severe thrombocytopenia (loss of platelets that can lead to hemorrhaging) (p less than 0.01).
Furthermore, platelet level at day 14 after TBI was the strongest predictor of survival in these studies (p less than 0.001), whereas neither neutrophil level nor days of febrile neutropenia were accurate predictors of survival. No death in the NEUMUNE-treated group was attributable to bleeding, whereas 10 of the 13 deaths in the vehicle group were ascribed to bleeding. This difference was highly significant. The Company believes these findings indicate that therapies to protect platelet levels are at least as important as therapies to protect neutrophils in the setting of ARS.
As previously reported in the November 2006 issue of International Immunopharmacology (available at www.elsevier.com), Hollis-Eden has also conducted studies with NEUMUNE in rhesus monkeys exposed to 400 cGy of TBI and has shown protection with NEUMUNE at various doses ranges. Representative data from these studies showed that giving the compound once per day for 5 days by intramuscular injection reduced the number of days of severe neutropenia from 12 to 3. Similarly, days of thrombocytopenia were reduced from 8 days to 0 days. Both of these results were statistically significant.
Hollis-Eden also has conducted Phase I clinical studies in the U.S. and The Netherlands to assess the safety of NEUMUNE in healthy human volunteers. Results from these studies indicate the compound was generally well tolerated, with pain and swelling at the injection site being the most commonly reported adverse event. In addition, the Phase I multi-dose results indicate that these volunteers experienced statistically significant increases in neutrophils and platelets during the study.
Hollis-Eden is developing NEUMUNE with the goal of securing an advance purchase contract for NEUMUNE under Project BioShield, legislation that has allocated $5.6 billion to purchase medical countermeasures against weapons of mass destruction. The Department of Health and Human Services (HHS) is currently conducting a solicitation for ARS medical countermeasures under this program. HHS has indicated its estimated contract award date under this solicitation is March 7, 2007.
The Company is developing NEUMUNE under an FDA rule adopted in 2002 (the Animal Efficacy Rule) designed for medical countermeasures to weapons of mass destruction. Pursuant to this rule, for indications in which it would be unethical to conduct efficacy studies in humans (as is the case with radiation injury), approval may be granted on the bases of efficacy in relevant animal species and evidence that the product is safe when administered in humans.
The FDA has further indicated that it would prefer efficacy studies be performed in non-human primates. Currently, in the absence of a surrogate marker for death from ARS, improvement in survival itself is the requirement for regulatory approval when the drug is administered to monkeys after they are irradiated. The Company is not aware of any drug approved or in development other than NEUMUNE that has demonstrated a survival advantage as a single agent when administered to non-human primates after lethal radiation exposure without other clinical support.
In a nuclear mass casualty scenario, it would be difficult to accurately triage patients and determine who is most in need of the limited amount of medical care that would be available. In a city such as New York City, less than 10% of those potentially exposed to a level of radiation that today requires hospitalization would likely have access to a hospital bed in such a scenario, and fewer still would have access to the necessary supportive care such as platelet transfusions that may be required for survival. Recognizing these practical realities, Hollis-Eden is developing NEUMUNE to be useful across a full range of radiation exposures. This could allow the compound to benefit those exposed to lethal radiation doses and who do not have access to hospital care, those who may have access to hospital care but face limited supplies of critical treatments, as well as those who may have been exposed to lower doses of radiation but whose concomitant injuries may still make them vulnerable.
"This peer reviewed publication is a culmination of years of cooperative research between Hollis-Eden and the U.S. Department of Defense," stated Richard Hollis, Chairman and CEO of Hollis-Eden Pharmaceuticals, Inc. "This adds to an extensive body of published literature with NEUMUNE in models of radiation injury in studies conducted by a number of scientific collaborators including Dr. Roger Loria, Professor of Microbiology and Immunology at Virginia Commonwealth University, and scientists from DoD and Hollis-Eden who have been co-developing NEUMUNE for the military and homeland security since late 2001."
Hollis-Eden Pharmaceuticals, Inc. is a world leader in the development of a proprietary class of adrenal steroid hormones as novel pharmaceuticals for human health. Through its 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 steroid hormones are 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. Certain patents related to NEUMUNE are licensed to Hollis-Eden by Roger Loria, Ph.D., a professor of microbiology and immunology at Virginia Commonwealth University. 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, visit the Company's website at www.holliseden.com.
This press release contains forward-looking statements within the meaning of the federal securities laws concerning, among other things, the potential and prospects of the Company's drug discovery program and its drug candidates. Any statement included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause the Company's actual results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such statements are subject to certain risks and uncertainties inherent in the Company's business, including, but not limited to: 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 or agencies, 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. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by law, the Company undertakes no obligation to update or revise the information contained in this press release as a result of new information, future events or circumstances arising after the date of this press release.
Dan Burgess, Chief Operating Officer and CFO
Scott Rieger, Director, Corporate Communications
Posted: February 2007