| March 12
March 12 A dying seven-year-old boy who is
suffering from a viral infection could receive an unapproved
treatment as early as Wednesday after a drugmaker struck a deal
with U.S. regulators to provide the medicine.
Pharmaceutical company Chimerix Inc, lobbied by
supporters of Josh Hardy in a campaign that has gained national
attention, will make him the first patient in a 20-patient pilot
trial of open-label brincidofovir (CMX001).
The drug, used to treat adenovirus infections in patients
with weakened immune systems, has not been approved by the U.S.
Food and Drug Administration (FDA) and was initially withheld by
the Durham, North Carolina-based company.
"Being unable to fulfill requests for compassionate use is
excruciating, and not a decision any one of us ever wants to
have to make," Chimerix President and Chief Executive Kenneth
Moch said in a statement on Tuesday.
"It is essential that each individual in a health crisis be
treated with equal gravity and value."
Hardy remains in a critical condition in intensive care at
St. Jude Children's Research Hospital in Memphis, Tennessee,
after a bone marrow transplant left him with the adenovirus.
He has battled kidney and other cancers since he was nine
months old, Internet biographies say.
"Glory to GOD! They are releasing the drug for Josh!" his
mother, Aimee Hardy, wrote in a Facebook post after the
A "Savejosh" Facebook page, which had garnered nearly 23,000
"likes", was used to convey messages of solidarity with the
ailing boy and his parents, and to organize a rally at Chimerix
The FDA-Chimerix agreement stemmed from a "compassionate
use" policy clause that at times allows drugmakers to administer
unapproved treatments to patients with life-threatening
CNN reported St. Jude said it was to receive the drug within
48 hours, but warned its safety and effectiveness has not yet
been established for use in treating children.
A hospital spokesman was not immediately available to