FDA Approves Clinical Trial for Chimerix Smallpox Drug
Posted June 28, 2006
RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has given RTP-based
approval to conduct a clinical trial for its proposed treatment of smallpox and complications resulting from smallpox vaccine.
Chimerix is a developer of antiviral therapeutics that are delivered orally.
The company plans to begin a Phase I clinical trial of healthy volunteers now that the FDA has given its OK to a new drug application for the drug called CMX001.
"Smallpox is a devastating bioterrorism threat and vaccination is not an option for more than 40 million Americans with compromised immune systems," said George Painter, Chimerix president and chief executive officer. "Using our platform technology, we have developed CMX001, an orally available drug candidate. We expect CMX001 to have utility not only for the treatment of smallpox infections in people but also as a treatment for the adverse side effects associated with smallpox vaccination."
Smallpox, anthrax and the botulism toxin are considered among the most feared bioweapons that could be developed by terrorists. Chimerix is developing CMX001 through a $36.1 million grant from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. The grant was awarded in 2003. The company also received $11 million in venture funding in 2004.
CMX001 has already been used to treat orthopox virus infections - a viral class that includes smallpox - in animal models, the company said.
Smallpox, once one of the most feared killers of mankind, was eradicated as a disease in 1979. It was stopped through a global vaccination program.
Smallpox is transmitted from person to person by infected aerosols and air droplets spread in face-to-face contact with an infected person after fever has begun, especially if symptoms include coughing, according to the World Health Organization's website. The disease can also be transmitted by contaminated clothes and bedding, though the risk of infection from this source is much lower, according to the WHO.
Chimerix was launched in 2002. It utilizes proprietary drug development technology developed at the University of California at San Diego and the Veterans Administration Hospital in San Diego, CA.
Painter, a former executive with Triangle Pharmaceuticals and Glaxo Wellcome, was among the early pioneers in efforts to develop drugs to combat HIV. Triangle developed the drug Coviracil before being acuqired by Gilead Sciences in 2003.