Healthcare Industry News: E2100
News Release - October 13, 2006
Hollis-Eden Pharmaceuticals Presents New Clinical Data That Support Use of NEUMUNE in Mitigating Acute Radiation Syndrome and Healthcare-Associated InfectionsSAN DIEGO--(HSMN NewsFeed)--Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH ) announced today positive new clinical data on NEUMUNE(TM) (HE2100) from a study designed to evaluate the safety and hematopoietic activity of the compound in healthy adult and elderly adult human volunteers. The findings have important potential implications for the mitigation of both Acute Radiation Syndrome (ARS) and nosocomial (healthcare-associated) infections -- two indications for which NEUMUNE is currently being developed under open INDs. The data are being presented at a late-breaker session of the 44th Annual Meeting of the Infectious Disease Society of America ("IDSA") held October 12-15, 2006, in Toronto, Ontario.
The new data included in the presentation were generated from a double-blind, placebo controlled multi-dose trial that enrolled a total of 18 human subjects separated into two equal cohorts, one with an average age of 29.4 years and the other with an average age of 68.2 years. The subjects received IM injections of either 200 mg of NEUMUNE or placebo once per day for 5 days. NEUMUNE was generally well tolerated in both cohorts, with injection site reactions of mild to moderate severity recorded at similar rates between NEUMUNE- and placebo-treated subjects being the most common drug-related adverse event.
Important potential indications of bone marrow regeneration were observed, as neutrophil and platelet levels were elevated from baseline through at least 28 days in NEUMUNE-treated patients in both cohorts. In addition, the increase in neutrophil and platelet counts was statistically significant in NEUMUNE-treated patients versus placebo-treated patients at multiple time points in a pooled analysis of both cohorts. The magnitude of the neutrophil and platelet responses after NEUMUNE treatment seen in the elderly appeared at least as great as that seen in the younger cohort treated with NEUMUNE. Further, the responses in both human cohorts were comparable in magnitude to the responses previously observed in the Company's studies with a 15 mg/kg dose of NEUMUNE in unirradiated rhesus monkeys. As previously reported, this same 15 mg/kg dose of NEUMUNE administered to monkeys exposed to 600 cGy of total body irradiation conferred a significant survival advantage versus animals receiving placebo.
Neutrophils and platelets are recognized as key components of innate immunity, the body's first line of defense against infections. Platelets are also critical for controlling bleeding. The ability to raise both neutrophil and platelet levels in adult and elderly adult humans provides further evidence that the beneficial radioprotective effects observed in previous preclinical ARS studies with NEUMUNE in irradiated monkeys may be translatable to humans. Observing this effect in the elderly may be especially important in the ARS setting, since the innate immune system in the elderly is frequently compromised and this population may be particularly vulnerable to radiation sickness after a nuclear event.
Similarly, the safety profile and activity observed in the elderly cohort in this study provides strong support for conducting further clinical trials with NEUMUNE in the area of healthcare-associated infections. The ability to elevate neutrophils and platelets across a 28-day period following just five injections of NEUMUNE may be very important to patients requiring longer-term care in a hospital or healthcare facility. These patients tend to be elderly and, as described above, are also generally more vulnerable to infections due to compromised innate immunity.
Of the 34 million patients admitted to U.S. hospitals and healthcare facilities each year, approximately two million contract healthcare-associated infections, leading to an estimated 90,000 deaths annually. Healthcare-associated infections are currently the fourth leading cause of death in the United States and present a major problem for immune suppressed patients. Many healthcare-associated infections can no longer be cured with commonly used antibiotics. Today, for example, it is estimated that 60% of staphylococcus infections are multi-drug resistant strains. Stimulating innate immunity to reduce healthcare-associated infections would address an important healthcare problem where no pharmaceutical alternatives other than antibiotics currently exist.
In addition to its effect on bone marrow regeneration, data provided at the meeting also indicate NEUMUNE has anti-infective and anti-inflammatory properties in a variety of in vivo preclinical models. For example, in a mouse inflammatory lung model, NEUMUNE decreased the production of the inflammatory cytokine TNF-alpha, and in a murine endotoxin shock model NEUMUNE increased survival and decreased TNF-alpha production. In addition, NEUMUNE has been reported in the literature to be effective in preclinical models of a variety of viral and bacterial infections, including improving survival against lethal Enterococcus faecalis, Klebsiella pneumoniae and Pseudomonas aeruginosa infections. These are types of organisms typically found in healthcare-associated infection patients.
"The clinical findings presented here suggest that NEUMUNE may act to regenerate host innate immune response and potentially benefit both victims of high-dose radiation exposure as well as patients at high risk of contracting healthcare-associated infections," said Richard B. Hollis, Chairman and Chief Executive Officer of Hollis-Eden. "These data are consistent with data previously presented from an earlier multi-dose clinical study of NEUMUNE in 39 healthy volunteers. With these new findings we are further validating our ability to translate data from animal studies into human clinical trials. In the last few months, we announced several animal studies with our second-generation drug candidates that show promising data in multiple disease conditions. This newly reported human data with NEUMUNE, therefore, bode very well for the potential of our second-generation drug candidates to demonstrate activity in human studies. It has always been our goal to expedite the Company's short-term commercial opportunities, while strengthening our technology platform and diversifying our product pipeline to build shareholder value for years to come."
Hollis-Eden Pharmaceuticals, Inc. is developing a proprietary new class of small molecule compounds that are metabolites 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(TM) (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, 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.
Source: Hollis-Eden Pharmaceuticals
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.