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.
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.
