<< Back
Hollis-Eden Releases Data from NEUMUNE Study Indicating Survival Benefit against High-Dose Radiation Exposure
Results From Pilot Study Presented at American Society for
              Therapeutic Radiology and Oncology Meeting
SAN DIEGO--(BUSINESS WIRE)--Oct. 4, 2004-- Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) today released data from a pilot study indicating that non-human primates treated with NEUMUNE(TM)(HE2100) after exposure to a high dose of radiation experienced an improved rate of survival over animals receiving placebo or no treatment. NEUMUNE is an investigational immune regulating hormone being developed by Hollis-Eden as a treatment for acute radiation injury pursuant to the U.S. Food and Drug Administration (FDA) "animal rule" for countermeasures to weapons of mass destruction. The Company is presenting the data this week at the 46th Annual Meeting of The American Society for Therapeutic Radiology and Oncology (ASTRO) in Atlanta, Georgia, October 3-7, 2004.

Under the FDA animal rule, because it would be unethical to conduct efficacy studies in humans, results in animals are used as a surrogate for efficacy results in humans. Given this situation, the FDA has indicated to the Company that it would prefer for the efficacy endpoint in any pivotal trial in animals to include an improvement in survival. As such, over the last several months Hollis-Eden has developed a proprietary preclinical model in non-human primates that employs a dose of radiation that approximately 50% of untreated animals can survive. The data from this model reported at the ASTRO meeting included results from a total of 30 Rhesus macaques. Ten of the animals received no treatment, while 10 received placebo and 10 received NEUMUNE beginning several hours after radiation exposure. Data presented showed 90% (nine of ten) of the NEUMUNE treated animals survived compared to an overall survival rate of 55% among the animals receiving either placebo or no treatment (11 of 20). While a pivotal study designed to demonstrate a statistically significant difference in survival was originally anticipated to require 100-200 animals, it was encouraging to note that even with only 30 animals in this pilot data set, the results approached statistical significance (p=0.07).

Consistent with the historical medical literature, the primary cause of mortality in this model appears to be a combination of hemorrhage (uncontrolled bleeding) and sepsis (massive systemic infection). Critical to protecting against these events are two key cell types produced by the bone marrow -- clotting elements known as platelets for protecting against hemorrhage and white blood cells known as neutrophils which protect against infections that can lead to sepsis. High-dose radiation is known to damage the bone marrow, leading to a severe depletion of platelets (thrombocytopenia) and a dramatic loss of neutrophils that can be accompanied by fever caused by infection (febrile neutropenia).

The data presented indicated that NEUMUNE treatment was able to provide a statistically significant improvement in both thrombocytopenia and febrile neutropenia in this study. The Company believes it is this ability to protect these multi-lineage components of the bone marrow that is providing the survival benefit that was observed. These results are also consistent with previous studies in sub-lethally irradiated non-human primates that showed improvements in both platelets and neutrophils in NEUMUNE treated animals compared to placebo. The ability to provide protection against both bleeding episodes and systemic infections with a single agent has the potential to make NEUMUNE useful in an outpatient setting, without the need for hospitalization, which may be particularly important in a mass casualty scenario.

NEUMUNE was well tolerated in this study. The only observation noted in the NEUMUNE treated animals was localized swelling that was variable in severity and that was ameliorated over time without apparent clinical consequence during the study period. At the end of the observation period, surviving animals in all dosing groups had generally recovered normal bone marrow function.

The dose of NEUMUNE that was used to validate this model was at the high end of the range anticipated for use in humans. Additional studies designed to determine the minimum effective dose in this survival model are being initiated. Assuming results from these additional studies are successful, and subject to additional feedback from the FDA, the Company's goal remains to initiate pivotal studies in the next few months.

"This is the first time NEUMUNE has been evaluated in a primate survival model of radiation exposure and this initial result is very exciting," said Dr. Dwight Stickney, Vice President, Medical Affairs. "We believe the model we have developed is one that recognizes the reality of the effects of a mass casualty scenario following a nuclear event and the resulting inability of the local healthcare system to provide anything more than rudimentary care for the great majority of those who are affected. While additional studies need to be performed to confirm and extend these initial findings, we believe we have both defined, and shown potential benefit in, a model of the most stringent and relevant endpoint for radiation injury protection -- survivability of high-dose radiation exposure.

Both The New England Journal of Medicine and the British Medical Journal (BMJ) have depicted the health consequences a relatively small and crude nuclear device would have if it were detonated in a major population center. The BMJ reported that if a 12.5-kiloton nuclear device were detonated in New York City, approximately 50,000 people would die from the initial blast, 200,000 would die shortly thereafter from severe bone marrow damage and an additional 700,000 would be at risk because of radiation sickness resulting from bone marrow damage. It also notes that the medical infrastructure would be overwhelmed and outside assistance delayed due to the contamination of the area. The BMJ further indicated that recent guidelines for treating victims of radiation exposure recommend that persons exposed to even moderate doses of radiation be admitted into a hospital for observation.

"The need for an effective medical countermeasure that protects the lives of Americans against a nuclear terrorist threat has never been greater," commented Richard Hollis, Chairman and CEO of Hollis-Eden. "The consensus today, shared by both presidential candidates and by congressional representatives on both sides of the aisle, is that nuclear material in the hands of terrorists poses the greatest threat to our nation. This threat will be with us for as long as terrorists have the potential to acquire nuclear materials or weapons produced during the Cold War and as long as nuclear proliferation among hostile states remains unchecked.

"Given this reality," added Hollis, "stockpiling medical countermeasures for radiation injury is critical to the protection of our nation's security. We believe NEUMUNE is a very attractive candidate to meet this unmet medical need. First and foremost, NEUMUNE has now shown a potential survival benefit in a challenging model of radiation injury, in addition to providing protection against bleeding and systemic infections. Also, given the cost-effectiveness of the compound, NEUMUNE is especially well-suited for inclusion in the Strategic National Stockpile in quantities sufficient to protect significant portions of the population. And, it offers the practical advantages of an agent that can be administered outside of the hospital setting at a time when the healthcare system may be overwhelmed. Such a compound could be instrumental in helping first responders and emergency planners alleviate the fear and anxiety among civilians that might otherwise lead to panic and chaos. For these reasons, we believe NEUMUNE is the type of promising new therapy that was envisioned by President Bush and the U.S. Congress in enacting the BioShield legislation to spur development of important new countermeasures to weapons of mass destruction."

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 (IRHs). 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 compounds under development, including NEUMUNE, which the Company is developing for use in protection from radiation injury; PHOSPHONOL(TM), a non-IRH candidate for providing protection against DNA mutations from radiation exposure and chemotherapy treatment; and IMMUNITIN(TM), which has shown activity in a variety of infectious diseases, including HIV/AIDS, tuberculosis and malaria. Hollis-Eden is also developing IRHs for protection from chemotherapy and other conditions of immune dysregulation. 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 ability to successfully complete preclinical and clinical trials within specified timelines, if at all; the ability to obtain regulatory approval for NEUMUNE, even if shown to be effective in preclinical studies; the ability to receive any stockpiling orders for NEUMUNE from the U.S. 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.

CONTACT: Hollis-Eden Pharmaceuticals
Dan Burgess or Scott Rieger, 858-587-9333
or
BMC Communications
Brad Miles, 212-477-9007, x17

SOURCE: Hollis-Eden Pharmaceuticals, Inc.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding Hollis-Eden Pharmaceuticals's business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.