Hollis-Eden Announces Plans to Respond to Department of Health and Human Services' Request for Information -- RFI.SAN DIEGO -- DHHS DHHS Department of Health & Human Services (US government) DHHS Dana Hills High School (Dana Point, California) DHHS Deaf and Hard of Hearing Services DHHS Deaf and Hard of Hearing Services Requests Information on Therapeutics to Treat Neutropenia and Thrombocytopenia Thrombocytopenia Definition Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. Associated with Acute Radiation Syndrome (ARS) Hollis-Eden Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :HEPH HEPH Hollis Eden Pharmaceuticals, Inc ) today announced plans to respond before the December 20, 2004 deadline to a Request for Information (RFI), issued by the Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Health and Human Services, HHS (DHHS), for therapeutics to treat neutropenia and thrombocytopenia associated with Acute Radiation Syndrome (ARS). An RFI begins a process by which the government can contract with industry for large-scale manufacturing and delivery of licensable products to the Strategic National Stockpile The Strategic National Stockpile (SNS) of the U.S. Centers for Disease Control is a national repository of antibiotics, chemical antidotes, antitoxins, life-support medications, IV administration, airway maintenance supplies, and medical/surgical items. in preparation for response to a public health emergency. ARS, also referred to as radiation sickness, is an acute illness caused by high doses of radiation exposure over a significant portion of the body in a relatively short time period. This exposure results in the depletion of hematopoetic stem cells and progenitors, resulting in severe neutropenia and thrombocytopenia. Severe neutropenia can significantly increase an individual's susceptibility to lethal infections, while thrombocytopenia increases the risk of hemorrhage. Currently there are no approved therapeutics to mitigate ARS. Hollis-Eden is developing NEUMUNE(TM) (HE2100), an investigational immune regulating hormone for acute radiation injury, pursuant to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) Animal Efficacy Rule for countermeasures to weapons of mass destruction Weapons that are capable of a high order of destruction and/or of being used in such a manner as to destroy large numbers of people. Weapons of mass destruction can be high explosives or nuclear, biological, chemical, and radiological weapons, but exclude the means of transporting or . On October 4, the Company presented data at a major medical meeting showing NEUMUNE's ability to provide a statistically significant improvement in both thrombocytopenia and febrile neutropenia in non-human primates following high doses of radiation exposure. 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. "Because there are no approved therapeutics to treat ARS, we believe NEUMUNE represents an important potential advancement in the fight against nuclear terrorism and is responsive to the intent of this RFI," commented Richard Hollis, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Hollis-Eden. "We look forward to communicating with the U.S. government with respect to this critical threat to our national security." To view the RFI, you can access it from the following URL URL in full Uniform Resource Locator Address of a resource on the Internet. The resource can be any type of file stored on a server, such as a Web page, a text file, a graphics file, or an application program. : http://www1.eps.gov/spg/HHS/OOS/OASPHEP/Reference%2DNumber%2DRFI%2DORD C%2D05%2D01/SynopsisR.html. Hollis-Eden Pharmaceuticals, Inc. is a development-stage pharmaceutical company based in San Diego, California “San Diego” redirects here. For other uses, see San Diego (disambiguation). San Diego is a coastal Southern California city located in the southwestern corner of the continental United States. As of 2006, the city has a population of 1,256,951. , 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 DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. mutations from radiation exposure and chemotherapy treatment; and IMMUNITIN(TM), which has shown activity in a variety of infectious diseases, including HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome , 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. |
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