BIOWIRE2KMINNEAPOLIS--(BUSINESS WIRE)--Feb. 23, 2006--In a timely response to a new request for radiation countermeasures from the United States government, Humanetics Corporation said today that it has submitted a proposal to the Department of Health & Human Services (HHS) to provide up to 100,000 doses of BIO 300, its oral countermeasure for exposure to ionizing radiation resulting from a nuclear attack. BIO 300 is believed to be the first known oral agent that can be safely self-administered by large civilian populations. Humanetics' proposal is in response to the HHS mandate toentify medical countermeasures to mitigate or treat acute radiation syndrome (ARS) as part of a public health emergency response to a radiological or nuclear event. Most available treatments for ARS require physician supervision and/or refrigerated storage--both of which are impractical during an event of this nature. By contrast, BIO 300 is a "next generation" medical countermeasure considered to be a safe, non-toxic oral agent that can be self-administered and stored without refrigeration.According to Ronald J. Zenk, President and CEO of Humanetics Corporation, "Based on our preclinical work on BIO 300 with the Department of Defense (DOD), we are confident it will be a safe and practical countermeasure for ARS. Our research shows multiple benefits of BIO 300 over existing therapies, including enhanced safety, lower risk of side effects and the ability for large populations to stockpile the agent and self-administer in the event of an accidental or terrorist nuclear incident," he explained.The recent request from HHS expands U.S. Government interest in Humanetics' radiation countermeasures beyond the Department of Defense to include a focus on civilian preparedness for a catastrophic contamination event.Pre-Clinical Studies Conducted in Collaboration with Dept. of Defense (DOD)Studies on BIO 300 are being conducted under a Cooperative Research and Development Agreement (CRADA) with the Armed Forces Radiobiology Research Institute (AFRRI), a research institute within the Uniformed Services University of the Health Sciences (USU), a fully accredited graduate education university within the DOD, and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF), a private, not-for-profit organization authorized by Congress to support medical education and research at USU and throughout the military medical community. Humanetics said it will work with AFRRI to complete the remaining pre-clinical studies on BIO 300 within the next few months and will file an Investigational New Drug (IND) application with the Food & Drug Administration (FDA) by mid-2006.Broad Collaboration with DefenseLast December, Humanetics received a $1.25 million federal grant from the DOD's 2006 Appropriations Budget to further develop a range of ARS countermeasures. To date, the Company hasentified two potentially effective agents--BIO 300 and BIO 500--both of which have been shown to be effective in animal models.Humanetics is currently collaborating with AFRRI and HJF to develop a pipeline of safe, low-cost oral countermeasures for ARS. Humanetics has entered into three CRADAs with these two groups. One of these agreements is a"Multi-Project CRADA" for ongoing development of a pipeline of candidate compounds.Humanetics said that its work on both BIO 300 and BIO 500 would be completed simultaneously.About Humanetics CorporationHumanetics is a privately-held specialty pharmaceutical company headquartered in Minneapolis, Minnesota. The Company is focused on the rapid discovery, development and commercialization of orally-administered bioactive compounds for the prevention and treatment of diseases in categories with urgent and unmet needs. The Company has several proprietary compounds in preclinical and/or clinical stages of development in the areas of bioterrorism, Alzheimer's disease and obesity. For more information, visit: http://www.humaneticscorp.com.This Press Release contains discussion of certain expectations regarding Humanetics' future performance. These forward-looking statements are based on the Company's current views and assumptions. Actual results could differ materially from these current expectations and projections, and from historical performance.LATITUDEPam Pettinella, 952-404-1853 pam@latitude-c.com
Updates
Humanetics Responds to Request for Radiation Countermeasures from Department of Health & Human Services (HHS); U.S. Government Interest in Humanetics' BIO 300 Expands Beyond Department of Defense
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