|FOR IMMEDIATE RELEASE
Monday, September 17, 2012
New gel being developed to treat skin damaged by radiation
BARDA supports development of new multi-use product for bioterrorism response, severe thermal burns
One of the first gels to treat skin injuries caused by large doses of damaging radiation and severe thermal burns will advance to the next stages of development under a contract with the U.S. Department of Health and Human Services’ Assistant Secretary for Preparedness and Response.
The two-year, $3.4 million dollar contract with KeraNetics, LLC of Winston-Salem, N.C., is part of an effort by ASPR’s Biomedical Advanced Research and Development Authority to develop new medical products to protect health and safety during a radiological or nuclear emergency, such as the detonation of a nuclear bomb or improvised nuclear device. There are no products approved by the U.S. Food and Drug Administration to treat such skin injuries, known as cutaneous radiation injury.
Under the contract, KeraNetics will manufacture KeraStat Burn Gel for testing, determine how much radiation is required to produce a sufficient burn for efficacy testing, test the efficacy of the gel in animal studies, and develop a comprehensive strategy to apply for regulatory approval of the product. Independently, the company will conduct clinical studies on the gel’s use in treating severe thermal burns, such as from a building fire. These parallel research efforts may provide data that supports both product uses.
Nuclear bombs and improvised nuclear devices give off radiation that damages organs including skin. Radiation burns can cover part or all of the body. Radiation burns damage the skin’s cell layers causing inflammation, redness, and skin peeling. Severe radiation burns can cause extremely painful blistering, skin ulcers that reoccur or do not heal at all, or dead skin. Radiation burns potentially require months to years of treatment, including surgery to graft skin from one part of the body to the affected area.
Radiation burns can be accompanied by radiation sickness, also known as acute radiation syndrome. Acute radiation syndrome occurs when most or the entire body receives a high dose of radiation, usually over a short period of time, and which can be fatal.
The contract represents BARDA’s second for products to treat radiation burns and is the latest in BARDA’s portfolio of advanced research and development contracts focused on treating radiation-induced bone marrow, lung, and skin injuries caused by damaging levels of radiation. This approach recognizes that health care providers will need a variety of effective ways to diagnose and treat the wide range of illnesses and injuries resulting from a radiological or nuclear incident.
BARDA also supports the development of medicines to treat radiation-combined injury, in which the effects of radiation are combined with thermal burns, blast injury, or other trauma. Radiation-combined injury may occur as a result of a nuclear detonation. Many of the products that BARDA is developing may find uses outside of emergency medicine, in this case for severe thermal burns.
BARDA is seeking additional proposals for products that could be used to treat illnesses and injuries caused by high levels of radiation. BARDA is also interested in proposals for improved diagnostic tools that could measure an individual’s absorbed radiation dose following a nuclear denotation or radiation accident. Proposals are accepted through the current Broad Agency Announcement, BARDA-CBRN-BAA-12-100-SOL-00011, at the Federal Business Opportunities website (www.fbo.gov
BARDA, an agency within HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR), provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. To learn more about HHS, visit www.hhs.gov
ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. To learn more about ASPR and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov
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