DURHAM: Chimerix says social media aided release of drug to boy - WFLA News Channel 8

Durham company says social media helped in release of drug to dying boy

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Josh Hardy, 7, is hospitalized at St. Jude Children's Research Hospital in Memphis with an adenovirus infection. Josh Hardy, 7, is hospitalized at St. Jude Children's Research Hospital in Memphis with an adenovirus infection.
DURHAM, N.C. -

A drug maker from Research Triangle Park is offering a 7-year-old Virginia boy one last chance at life by administering a potentially life-saving drug that is still in clinical trials.

Josh Hardy is hospitalized at St. Jude Children's Research Hospital in Memphis with an adenovirus infection. With his heart and kidneys failing, doctors gave Josh just two weeks to live, but Durham-based Chimerix has a new drug that could save his life.

Chimerix announced Tuesday that it had reached agreement with the United States Food and Drug Administration to immediately begin treating Josh with the drug brincidofovir.

Doctors at St. Jude originally recommended the drug for what is called "compassionate use," however the drug's release was stalled by discussions between Chimerix and the FDA because it was in the final stages of clinical trials.

Chimerix CEO Kenneth Moch, however, said an extensive public campaign waged by Josh's family accelerated those talks.

"There is no doubt that the social media aspects of this helped to accelerate what had been an on-going dialog with the FDA," Moch said.

Moch said when he spoke to Josh's father, he told Hardy that such an effort was the right move.

"He did exactly what I would be doing as a parent, that is advocating as fiercely as possible for my child," Moch said. "I have nothing but praise and hope for the Hardy family and Josh."

Once the Chimerix received FDA approval to release the drug, it called Josh's doctors at St. Jude to let them know they should begin treatment. That approval for the trials came at a time when Josh's family had just about given up hope.

"As long as it had gone on, they kept saying, ‘No, no, no,' and we basically exhausted what we could do," Josh's grandmother, Mae Staton, said. "We were beginning to get very discouraged."

Moch said Josh is receiving the drug as part of the last phase of clinical test to be run on brincidofovir. It has taken 14 years to develop the drug to this point, and Moch said the earliest the drug could go on the market is 2016.

Moch said Josh will be the first patient in a pilot trial of brincidofovir. Nineteen others will also be given the drug as part of the last round of the clinical testing for the drug.

"This was never an issue of money, this was an issue of making the drugs available to one and not to many," Moch explained.

In cases like this, the FDA must approve a drug's release to an individual patient, and that patient must have a serious or life threatening condition.

The drug manufacturer and the patient's doctor must also make special arrangements to get the drug to the patient. And the physician must determine that the risk of taking an experimental drug is not greater than the risk of the disease.

Companies are not required to make experimental drugs available.

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    Steve Sbraccia

    Steve is an award-winning reporter for WNCN and former assistant professor. A seasoned professional, Steve is proud to call the Triangle home since 2005 after over two decades in Boston, Mass.  More>>

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