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Chimerix and USAMRIID Collaborate to Complete Preclinical Development of Smallpox Therapeutic
RESEARCH TRIANGLE PARK, NC, April 18, 2006 - Chimerix, Inc., a biotechnology company developing orally available, targeted medicines to treat smallpox and other viral infections, announced today that it has signed a Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) to evaluate Chimerix’s smallpox therapeutic, CMX001, in animal models maintained at USAMRIID.
The development of CMX001 falls under the animal efficacy rule of the U.S. Food and Drug Administration, which defines criteria for licensing agents directed against certain serious or life-threatening conditions, such as smallpox, that cannot be directly studied in humans. Agents developed under the animal efficacy rule are tested in humans for safety, but are tested for effectiveness in animals, usually in two species. The agreement with USAMRIID will provide Chimerix with the opportunity for testing CMX001 and other potential drug candidates in USAMRIID’s animal models of smallpox and monkey pox infection.
“Smallpox continues to pose a significant bioterrorism threat, yet to date there is no effective oral drug for the virus and an estimated 40 million people in America alone cannot be safely vaccinated,” said Dr. George Painter, Chimerix CEO. “This agreement with USAMRIID is critical to the development of CMX001.
Chimerix is currently developing CMX001 as an oral treatment for smallpox and for complications from the smallpox vaccine. Smallpox is a potentially devastating bioterrorism threat and vaccination poses significant risk for individuals with compromised immune systems or skin disorders.
Smallpox was eradicated in 1979 through the efforts of the World Health Organization (WHO). Currently, infectious variola, the causative agent of smallpox, is known to exist only in two WHO-sanctioned repositories, one in Russia and the other at the Centers for Disease Control and Prevention (CDC) in Atlanta. However, there is concern that undisclosed reference stocks of the virus may exist—and given its potential as a biological threat agent, development of smallpox therapeutics is a high priority. USAMRIID’s work with variola is conducted in the maximum containment laboratory at CDC.
USAMRIID, located at Fort Detrick, Maryland, is the lead medical research laboratory for the U.S. Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute’s mission is to conduct basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Material Command.
Chimerix, Inc. is a privately held biotechnology company creating and developing orally available medicines from bioactive molecules. Application of Chimerix's proprietary technology enhances oral availability, stabilizes drug in plasma, and facilitates the delivery of drugs into targeted tissues. Known drugs can be modified to improve dosing parameters, broaden therapeutic applications and decrease the risk of adverse reactions. Chimerix is applying its technology towards discovery and development of oral drugs for the treatment of smallpox, cytomegalovirus infection, drug-resistant HIV infection and viral hepatitis. Chimerix was founded in 2002 and is headquartered in Research Triangle Park, NC.
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