Josh Hardy, the little boy fighting for his life as an adenovirus infection ravages his body, has just been enrolled in a 20 patient study to be launched tomorrow by Chimerix, the drug company that up until now had denied his family access to the still-developmental drug. Chimerix has been working on the drug Brincidofovir and until now, had refused to release the potentially life saving oral treatment to the boy.
Josh Hardy is a 7-year-old boy who has battled cancer four times since he was nine months old. It was discovered late last year that he needed a bone marrow transplant, and after the transplant took place in January, the adenovirus infection ripped through his body, causing internal bleeding and the young cancer warrior to vomit several times a day, and in some cases, he was vomiting blood. His parents had launched a grassroots campaign to put pressure on the drug company to release the oral form of Brincidofovir in hopes of saving Josh’s life. Until today, the drug company had flatly refused to allow compassionate use of the drug under any circumstances, and has since been flooded by hundreds of emails and tweets, imploring the company to change its mind.
The United States Food and Drug Administration (FDA) allows for compassionate use of the drug, particularly in cases where the drug could lead to a life or lives being saved. The FDA approved over 900 compassionate use cases last year alone.
The new adenovirus study sees young Josh Hardy become its first patient to be issued Brincidofovir tomorrow, and with the study’s launch, the boy should be receiving the drug in short order. The FDA has determined it will work “expeditiously” with the drug company to develop a Phase 3 study which will be a continuation of the initial pilot study.
Chimerix describes brincidofovir as an antiviral drug that could be used to prevent and ultimately treat infections and diseases that are caused by DNA viruses. Doctors at St. Jude Hospital, where Josh is being treated, believe that the oral form of the medication will go a long way to helping the boy and likely even save his life. However, because of the drug company’s refusal to provide the doctors the drug, Josh has been living day-to-day in critical condition while his parents have held a vigil by his bedside.
Chimerix CEO Kenneth Moch has said that he cannot release the drug to save Josh’s life although it could save it. He has argued that he cannot release the drug to the family because of ethical concerns, rather than the $50,000 price tag associated with treating the boy. Since the drug is still in its trial stages, it is uninsured, which is why there is such a hefty price tag associated with its release to the Hardy family. A charity devoted to the treatment of pediatric cancers offered to cover the costs in a phone call to Moch, but according to Richard Plotkin, vice chair of the Max Cure Foundation, said the Chimerix CEO remained firm in his refusal.
Moch says his company remains committed to providing sound antiviral drugs for everyone, not just in compassionate care cases. In a clear reference to the Hardy case, he notes that “being unable to fulfill requests for compassionate use is excruciating, and not a decision any one of us ever wants to have to make.”
Josh Hardy is set to become the first patient in the open-label brincidofovir study March 12. While it has been noted in previous studies that the drug is highly effective in children, the new study now allows the drug to be explored as a potential cure for adenovirus infections.
By Christina St-Jean