Release Brincidofovir for compassionate use to treat the adenovirus plaguing 7-year old Josh Hardy right now.
  • Petitioned Chimerix

This petition was delivered to:

Chimerix

Release Brincidofovir for compassionate use to treat the adenovirus plaguing 7-year old Josh Hardy right now.

    1. Regina Breedlove
    2. Petition by

      Regina Breedlove

      Mechanicsville, VA

  1.  
  2.   
March 2014

Victory

On the evening of March 11, 2014, Chimerix announced that it had reached agreement with the FDA for a new trial of Brincidofovir that will include Josh. On behalf of our family and friends, I would like to thank everyone who signed this petition. With everyone's support, Josh and many others will have the opportunity to receive CMX001 (Brincidofovir): the life saving antiviral drug made by Chimerix. You have made a difference in the life of a little boy and also many others. We ask that you continue to keep Josh in your thoughts and prayers, as he still has a long road ahead of him.

When Josh, my cousin's son, was 9 months old, he was diagnosed with a malignant rhabdoid tumor of the kidneys. It’s a highly aggressive, rare form of cancer that only 15 children are diagnosed with each year. In November 2013, he had a bone marrow biopsy and learned he had a bone marrow disorder, as a result of a treatment he had earlier in his life. On New Year’s Eve, Josh checked into St. Jude for inpatient care. He started 10 days of chemotherapy, and on Jan. 10, got the bone marrow transplant.

Though he had heart and kidney issues before, the transplant caused a lot of complications for Josh. On Jan. 14, Josh had to go to the ICU for heart failure issues and just five days later was put on a ventilator. As soon as thing started to improve Josh the adenovirus showed up because of Josh’s compromised immune system. The medicine Josh was given through an IV to treat the infection ended up damaging his kidneys. 

His doctors recommended Brincidofovir, an antiviral drug manufactured by Chimerix that is still in trial form. They say that other children treated with the drug had their adenovirus clear up within two weeks. For complicated reasons, and because the drug is close to going to market, it isn’t available to Josh right now. 

According to the American Cancer Society’s website, medical professionals use the term “compassionate use” to refer to the treatment of a seriously ill patient using a new, unapproved drug when no other treatments are available.

Drugs that are being tested but have not yet been approved by the U.S. Food and Drug Administration are called investigational drugs. These drugs are generally available only to people who are taking part in a clinical trial (a research study that is testing the drug).

Single-patient access can be granted if the patient’s doctor requests the drug from the company that makes it.

Josh’s doctor did.

If the company agrees, the patient’s doctor works with the drug company to ask the FDA to approve the drug for use by this one patient.

Kenneth Moch, the company’s president and CEO, said Friday that Chimerix officials are “acutely aware of the situation faced by this patient.”

However, he said they cannot help Josh.

Moch said that because the drug is in phase-three clinical development, they cannot allow it to be used by patients through the compassionate use program.

He said that five years ago, much earlier in the drug’s development, Chimerix began receiving requests for emergency use for many viral infections.

While they could fulfill a small number of requests, two years ago they had to stop fulfilling those.

“As we progressed to larger and more complex safety trials, we made the decision two years ago to stop the program and focus resources on earning FDA approval,” Moch said.

He said the drug could be widely available in 2016—if they are lucky.

“We understand this great need,” he said. “That’s what drives us to focus on getting it available. It creates these really difficult complex situations where the need to pursue the formal clinical development under the FDA process takes precedent over other needs,” he said.

Josh's family continues to keep their faith in God and pray for Chimerix to find a way to help or for the virus to go away on it's own! Please join us in asking Chimerix to provide compassionate use access to this drug for Josh! 

To:
Chimerix
Release a dose of Brincidofovir for compassionate use to save 7 year old Josh Hardy!

Sincerely,
[Your name]

Recent signatures

    News

    1. Reached 17,500 signatures

    Supporters

    Reasons for signing

    • Kate Svagdis MACCLENNY, FL
      • 7 months ago

      This is America and we should do the most for our children not hide behind attorneys #FreeJustina

      REPORT THIS COMMENT:
    • Susan Pateracki COVINA, CA
      • 8 months ago

      The FDA has a problem with getting critical medication out to Patients. Not the first time. Josh and any child deserves special treatment and the FDA needs to release any medication that can help children. I see the Confirmed Victory. I am guessing that we got enough people signing the petition. If not, I need to know so I can get it out further. We need to get all the petitions needed to help Josh and other children

      REPORT THIS COMMENT:
    • Thomas Ivancso EAST HARTFORD, CT
      • 8 months ago

      Because it is basically the right thing to do and we need to show our support.

      REPORT THIS COMMENT:
    • Amy Stahl-Cacace NEW MILFORD, CT
      • 8 months ago

      To save the life of a child

      REPORT THIS COMMENT:
    • Juanita Tucker MEMPHIS, TN
      • 8 months ago

      I love children

      REPORT THIS COMMENT:

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