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Chimerix cleared to move smallpox drug into clinic

Antivirals developer Chimerix has received FDA clearance to begin phase I clinical trials of its oral smallpox infection treatment candidate, CMX001.

Chimerix will initiate a single-site phase I clinical trial to evaluate the safety of CMX001 in healthy volunteers. CMX001 is an oral antiviral drug candidate to be evaluated in the treatment of smallpox infections and complications resulting from smallpox vaccine.

CMX001 has been used to treat orthopox virus infections, a viral class that includes the smallpox virus, in animal models. The drug candidate is being developed in partnership with the US National Institute of Allergy and Infectious Diseases of the National Institutes of Health under a $36.1 million grant that was awarded to Chimerix in September 2003.

“Smallpox is a devastating bioterrorism threat and vaccination is not an option for more than 40 million Americans with compromised immune systems,” said Dr George Painter, Chimerix president and CEO. “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.”