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UPDATE: Family of boy who has beat cancer four times to use experimental drug

Updated: Tuesday, March 11 2014, 08:53 PM CDT
(CBS) -- Seven-year-old Josh Hardy has beaten cancer four times in his young life, but a rare virus is threatening his already weakened immune system. His family couldn't get their hands on the only experimental treatment that might help them because drug company, Chimerix, wouldn't release it outside of clinical trials, CBS affiliate WTVR in Richmond, Va. reports.

However, that all changed Tuesday, when the company decided to make Josh their first pilot test patient. 

While it's unclear that the drug, brincidofovir, will definitely help, the family and St. Jude Children's Hospital have said it might be the boy's only hope.

"This virus has really done a number on his little body, he's bleeding internally and he's in a lot of pain," his grandmother Mae Staton told the station.

Josh, who's from Fredericksburg, Va., was diagnosed with cancer in his kidneys while he was 9 months old, said Staton, and he's defeated it three more times since.

Chimerix, Inc. Tuesday announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) for the immediate initiation of a pilot trial of open-label brincidofovir for the treatment of adenovirus infections in immunocompromised patients.

The FDA has committed to work expeditiously with Chimerix on the design of a pivotal Phase 3 study that would be a continuation of this pilot study. Josh Hardy's story brought to public attention the often-devastating impact of adenovirus infection, and helped accelerate a discussion between the FDA and Chimerix regarding the need for additional clinical development to assess brincidofovir's potential in adenovirus infection.
This study is expected to begin with Josh Hardy as the first patient enrolled on Wednesday, March 12, 2014.

"This 20-patient open-label study underscores Chimerix's mission to develop innovative antiviral therapies in areas of high unmet need - for everyone," said Kenneth I. Moch, President & CEO of Chimerix. "Being unable to fulfill requests for compassionate use is excruciating, and not a decision any one of us ever wants to have to make. 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."

"We are pleased to be providing access to brincidofovir in a manner consistent with our focus on progressing clinical development toward a potential regulatory approval that would make it widely available to patients who might benefit from its use," said Hervé Momméja-Marin, M.D., Vice President, Clinical Research of Chimerix. "We are grateful to the FDA for their continuous guidance and assistance in expediting brincidofovir's development path forward."

Read more: http://www.nasdaq.com/press-release/chimerix-to-provide-brincidofovir-to-josh-hardy-as-first-patient-in-new-openlabel-study-in-patient-20140311-01275#ixzz2vi1aawzo

UPDATE: Family of boy who has beat cancer four times to use experimental drug


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