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Chimerix will now send medicine to dying Fredericksburg boy

After multiple news stories, there has been a sudden turn of events that could impact the life of a young boy, as a pharmaceutical company, under new treatment protocols, will be able to make a medicine unapproved by the U.S. Food and Drug Administration available to him.

We first reported on seven-year-old Josh Hardy, on Monday. He has been cancer free for two years, but he’s still fighting for his life just shy of his eighth birthday.

Despite beating cancer four times, now a rare virus has taken advantage of his compromised immune system, during a life-saving bone marrow transplant.

Doctors say beating the virus will require one particular drug called brincidofovir (brenz-a-dof-a-veer). The company Chimerix, which makes the drug, originally said it can’t be released outside of controlled clinical trials. 

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On Tuesday, the North Carolina based company Chimerix notified St. Jude that it will send the drug that could save Hardy’s life.

The company will send Brincidofovir within the next 48 hours.

In a press release Chimerix explained that it reached an agreement with the FDA for the immediate initiation of a pilot trial of open-label brincidofovir for the treatment of adenovirus infections in immunocompromised patients.

“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,” the company wrote.

The study is expected to begin with Hardy as the first patient enrolled on Wednesday, March 12, 2014.

St. Jude, the Memphis hospital where Hardy is being treated, released a statement: 

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.

10 comments

  • Rebecca Wright

    Why not? This is what we parents and families of kids with cancer face ALL THE TIME — Initial sympathy and then nothing. People running for the hills because they can’t deal with what we have to deal with.

    Please don’t think that you are immune, because you are not. Imagine how you would feel if this were YOUR grandson.

    Fortunately, we have many friends who are much more compassionate and active.

    • rebwt

      Gosh, snogale. Way to be compassionate! Please amend your “Don’t plan to have any, any time soon” to “Won’t have any kids.”

      • Belsma

        I went to school today and had a good and productive day and then I got home and read this amazing news! Be happy for this young boy and his parents. Good news! You should really try to happy for someone, even if it’s not for yourself.

  • MLee

    I don’t know the exact details of the companies original decision, but it appears the possible hangup may have been because it wasn’t approved by the FDA in any way shape or form for anything other than clinical trials. Now the FDA has given them permission. The company and owners may have faced criminal charges for distributing a drug only approved for clinical trials, not to mention possible litigation. While it’s easy to have a gut reaction of anger against the company, in the end it’s the Government Regulations that appear to have held this one back. It seems all they needed was a thumbs up from a Judge, FDA, someone in the Government to authorize this. Had the drug been released and the Government pressed criminal charges, would everyone have been there to stand by the owner during a criminal proceeding? I bet not.

  • Lauren

    Don’t worry about “snogale”. I’ve had his ignorant and hurtful comments removed. God bless this family, the FDA, Chimerix, and St. Jude. I pray he is restored to full health and life soon!

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