• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Hollis-Eden Comments on Issuance By the Department of Health and Human Services of Statement of Work for Acute Radiation Syndrome

Posted on: Friday, 30 September 2005, 21:00 CDT

Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) today announced that the Department of Health and Human Services (DHHS) has issued a Statement of Work (SOW) for therapeutics to treat neutropenia associated with Acute Radiation Syndrome (ARS). The purpose of the SOW is to inform and solicit comments from interested parties with respect to the scope, design and requirements of this potential BioShield procurement. The SOW is not intended to seek specific proposals, but rather to gather responses that can be considered in the preparation of a RFP for such procurement. Comments on the SOW are due back to DHHS in November 2005. The issuance by DHHS of the SOW follows the release in October 2004 of a Request for Information (RFI) for therapeutics to treat ARS, to which Hollis-Eden submitted a formal response in December 2004 with respect to its ARS drug candidate NEUMUNE(TM). On a parallel path, the Company has also recently submitted an unsolicited proposal to the Department of Defense, and is in discussions regarding a potential separate procurement for NEUMUNE for use by the military.

Commenting on the SOW, Richard B. Hollis, Chairman and Chief Executive Officer of Hollis-Eden, stated: "We view this as an initial step by the U.S. government to procure a medical countermeasure for ARS in order to protect citizens and first responders in the event of a nuclear terrorist attack or accident. While we have only received the document this afternoon, and have not had the opportunity to review it in detail, we believe the initial number of treatment regimens of a countermeasure for Acute Radiation Syndrome called for in the SOW (up to 100,000) is wholly insufficient relative to this major threat to our Homeland security. We believe stockpiling such a small quantity would leave hundreds of thousands of individuals at unnecessary risk in the event of a nuclear terrorist incident. Indeed, the document issued by HHS today calls for use of an ARS countermeasure in the event that individuals are exposed to radiation levels in excess of 100 - 200 rem, which would, according to leading medical journals, result in ARS in hundreds of thousands of people in a single city. We also believe focusing solely on neutropenia, which is a change from the original RFI, runs counter to data both in the literature and from our studies indicating thrombocytopenia (loss of platelets) is a significant source of morbidity and mortality from ARS. Such a focus would require significant additional treatment measures as well as hospitalization, none of which may be available in the midst of the chaos created by such an attack. Given the lack of availability of platelets in a mass casualty scenario, we believe it is critical to stockpile a compound like NEUMUNE, which appears from studies to date to be able to protect both neutrophils and platelets across a range of radiation exposures. We will be providing this feedback to DHHS in response to the SOW, along with other comments based on further review of the document. As we learn more about the assumptions behind this document, and have an opportunity to review it in further detail, we will be in a position to communicate our position further. We continue to believe NEUMUNE can be an important addition to our nation's stockpile of medical countermeasures to weapons of mass destruction, and will continue our discussions with DHHS and DoD on its potential procurement."

NEUMUNE

Hollis-Eden is pursuing an advance purchase contract under BioShield to provide its drug candidate NEUMUNE to the U.S. government's Strategic National Stockpile for use by the military, first responders and civilians who may be at risk of ARS. ARS is a potentially lethal condition caused by high-dose radiation exposure that might result from a nuclear or radiological terrorist attack or from an accident at a nuclear facility.

Hollis-Eden is developing NEUMUNE in collaboration with the Armed Forces Radiobiology Research Institute (AFRRI), an agency within the U.S. Department of Defense specializing in research on and development of countermeasures to radiation injury. The compound is being developed under an FDA rule (the Animal Efficacy Rule) designed for medical countermeasures to weapons of mass destruction. According to this rule, for indications in which it would be unethical to conduct efficacy studies in humans (as is the case with radiation injury), marketing approval may be granted based on the demonstration of efficacy in relevant animal species and successful completion of Phase I safety trials in humans. As previously reported, Hollis-Eden has conducted and reported on dose-ranging radiation studies with NEUMUNE in over 200 non-human primates. These studies have demonstrated beneficial effects of NEUMUNE on a number of important hematology parameters that are critical in ARS, and NEUMUNE treated animals in these studies also experienced a survival advantage relative to placebo treated animals.

Acute Radiation Syndrome (ARS)

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 hematopoietic stem cells and progenitors, resulting in severe neutropenia and thrombocytopenia. Severe neutropenia can significantly increase an individual's susceptibility to life threatening infections, while thrombocytopenia increases the risk of bleeding. Currently there are no therapeutics approved to mitigate ARS. 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.

A study published in the British Medical Journal (Vol 324, 2/9/02) has estimated that a 12.5-kiloton nuclear bomb detonated in New York City would cause 50,000 deaths immediately from the explosion, an additional 200,000 deaths from radiation injuries and several hundred thousand additional cases of radiation sickness.

Hollis-Eden Pharmaceuticals

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 Acute Radiation Syndrome (ARS); 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 such as autoimmunity. 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 complete preclinical and clinical trials successfully and within specified timelines, if at all; the ability to safely obtain sufficient blood levels of NEUMUNE in human clinical trials; 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.

Source: Business Wire

More News in this Category