(WJLA) - Seven-year-old Josh Hardy is fighting for his life. This Fredericksburg first-grader has beat cancer four times since he was nine months old. Now, he faces a new challenge: a virus he contracted after a January bone marrow transplant.
"He is working his butt off," says his mother, Aimee Hardy.
Josh’s mother is currently with him at a Memphis hospital, where doctors have told her that a medicine currently in clinical trials could save him. Brincidofovir is an anti-viral drug that is currently not on the market.
“I just feel like there is a way to do this," she says. "Where there is a will, there is a way, and we're really just not going to sit back when there's a drug available to make all the difference in the world for our son."
Now, a social media campaign has been launched to put pressure on the drug’s manufacturer to give the medicine to Josh’s doctors. In a statement on Monday, the company -- Chimerix Inc. -- responded:
This is one of hundreds of requests that Chimerix has received for the compassionate use of Brincidofovir. Providing Brincidofovir in any of these situations could very likely place the entire development program for Brincidofovir at risk.
Family and friends are rallying around this little boy in the hopes that the drug company will finally give in.
"It's heartbreaking. It's unbelievable that there is a drug that could help this young man and its being withheld," says neighbor Dave Grinnan.
"We just pray to God that Josh is gonna be here and trust in God that he's going to make him better and he's going to be home with us again and be the old Joshie," adds his grandmother, Mae Staton.
UPDATE: On Tuesday, March 11, Chimerix Inc. released a statement confirming that it would provide Josh Hardy with the drug. The release includes the following:
Chimerix, Inc. (Nasdaq:CMRX) today 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. 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."