There is great news for a 7-year-old Fredericksburg, Va. boy suffering from a life-threatening virus. St. Jude Children’s Research Hospital says Josh Hardy will be receiving an experimental drug sought by his family to treat his condition within the next 48 hours.
Hardy, who has overcome cancer four times, contracted the virus following a bone marrow transplant. He is currently being treated at St. Jude and doctors there believe the experimental anti-viral drug, brincidofovir, could help him recover.
Josh's story has grabbed national attention after Chimerix, the maker of brincidofovir, refused to give the drug to Hardy because they had stopped releasing it for “compassionate use” to patients like him two years ago.
Chimerix's CEO Kenneth Moch said his small company lacked the resources to handle all of the requests for the drug, while at the same time, conducting research to gain approval by the Food and Drug Administration.
“This drug is experimental and has not yet been approved by the FDA and the safety and effectiveness of the medication has not yet been established for use in children. For this reason, it will be administered under a new treatment protocol as approved by a committee charged with compliance to federal and institutional regulations for clinical research (IRB). It is also important to understand that this remains a critical and complex medical situation.”
"St. Jude will continue to pursue state-of-the-art treatment for Josh and all of our patients. We are grateful for the efforts of Chimerix, the FDA and many others who worked to achieve this outcome. We ask that you continue to keep Josh and his family in your thoughts."
"Behind all of the activity that's been going on in the public arena, we have been working with the FDA to find a path to make this drug available," Moch told FOX 5 on Tuesday. "Not only to Josh, obviously he's very needy, but to many other patients who have the potential need for a treatment for adenovirus infections, which is the virus Josh has."
To provide Josh with brincidofovir, Moch said Chimerix is "beginning a broader trial that will initially enroll 20 patients and will move to being what's called a pivotal Phase 3 study, so it will be designed to move potentially to the approval of brincidofovir by the FDA. The study has to be undertaken, but that is our hope and plan."
Hardy's parents have been spreading Josh's story through social media on Facebook and on Twitter using the hashtag #SaveJosh in an effort to get the drug maker to provide the drug to help treat his condition.
"The Hardy family really was wonderful in their work on this," said Moch. "They did help accelerate the discussion between the FDA and Chimerix. It had been ongoing, but it obviously focused both public attention and everybody's attention on this issue broadly, and Josh's need in particular, and so it did help us craft a solution and create a path forward."?
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