Chimerix releases brincidofovir for trial adenovirus treatment
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March 12, 2014
Chimerix Inc. today announced that, in agreement with the FDA, it will provide a pilot trial of the open-label, broad spectrum antiviral brincidofovir to a 7-year-old boy, who was diagnosed with widespread adenovirus infection after receiving treatment for thymus, lung and bone marrow cancers.
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Brincidofovir is an oral nucleotide analogue that may prove to be the first broad-spectrum antiviral to prevent and treat clinically significant infections and diseases brought on by DNA viruses.
Data from an exploratory trial presented in 2013 by the company showed encouraging antiviral results when brincidofovir treatment was initiated at the time of adenovirus detection. The antiviral has shown clinical efficacy against all families of DNA viruses that affect humans including cytomegalovirus, BK virus, herpes simplex and adenovirus. In previous trials, the medication showed a favorable safety profile with no evidence of kidney or bone marrow toxicity.
The pilot study will commence on March 12, 2014, with 7-year-old Josh Hardy enrolled as the first patient. The FDA and Chimerix noted in a press release that they will continue to collaborate as Chimerix launches a phase 3 trial as an extension of this pilot study.
“This 20-patient, open-label study underscores Chimerix's mission to develop innovative antiviral therapies in areas of high unmet need — for everyone. Being unable to fulfill requests for compassionate use is excruciating, and not a decision any one of us ever wants to have to make,” Kenneth I. Moch, president and CEO of Chimerix, said in a press release. “It is essential that each individual in a health crisis be treated with equal gravity and value, a principle we have upheld by pursuing further clinical study of brincidofovir that will inform its use in adenovirus and other serious DNA viral infections.”