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Fredericksburg first-grader fighting for his life

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Last May, 7-year-old Josh Hardy had a sunny disposition.

The then-kindergartner at Hugh Mercer Elementary School in Fredericksburg had been cancer-free for two years and was helping raise money for other kids at St. Jude Children’s Research Hospital, in Memphis, Tenn., where he was treated.

Now Josh needs help himself.

He recently had a bone marrow transplant and while recovering has developed an adenovirus, an acute infection that has left Josh in the intensive care unit at St. Jude.

The virus can be deadly for people, like Josh, who have a weak immune system.

“Normally, Josh’s immune system would be able to handle the adenovirus if his immune system was set free,” Josh’s mother, Aimee Hardy, wrote in a post on her son’s website. “The challenge is his immune system can’t be set free yet because his body is still trying to adapt to the new bone marrow cells. So to keep the body from killing the new cells, they have to suppress the immune system, thus creating ideal conditions for adenovirus to advance. Catch 22.”

Josh will turn 8 on March 31.

When he 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.

While he fought the disease, Josh’s family traveled between Fredericksburg and Memphis.

In September, Josh went for a checkup, and his blood tests indicated that something might be awry, Aimee Hardy said in a telephone interview Friday.

In November, 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, she said. He was able to go home for Thanksgiving.

The family traveled back to Memphis in December for testing, but were able to spend Christmas at home.


Then, 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.

On Feb. 2, he took a turn for the worse.

“Basically everything was falling apart—his heart, kidney and lungs,” Aimee said.

Then Josh started to improve.

But the adenovirus showed up because of Josh’s compromised immune system.

At first, Josh’s doctors just kept an eye on it. But it became more critical.

The medicine Josh was given through an IV to treat the infection ended up damaging his kidneys, Aimee said.

While he was at St. Jude, Josh was part of a study for Chimerix, a pharmaceutical company.


His doctors recommended Brincidofovir, an antiviral drug the company makes that is still in trial form. They say that other children treated with the drug had their adenovirus clear up within two weeks.

But for complicated reasons, and because the drug is close to going to market, it isn’t available to Josh right now, Aimee said.

“The company said, ‘Sorry, we have limited resources, we can’t give it to you,’” she said.

There is, however, something called compassionate use.

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.

“There are no words to express this compassion, what he and his family are going through,” he said. “We understand the complexity here.”

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.

“That’s very hard to put to an individual, personal level.”


Aimee has been encouraging family and friends to call the company in hopes of convincing them to let Josh take the medicine that could save his life.

Moch said they received hundreds of phone calls and emails and photos in support of Josh on Friday.

The 50-person company was formed in 2000 solely to develop this drug, Moch said.

Chimerix’s position is not good news for Josh and his family.

“We are grasping at straws right now, trying to do something” Aimee said.

Meanwhile, Josh is in rough shape in the ICU at St. Jude.

For the first time in 65 days, his three brothers are there with him.

“They’re here, but he’s not interacting with them,” Aimee said.

“He keeps saying, ‘I just don’t feel well’. He’s really going through a lot right now,” she said.

The drug that Josh needs is critical to his survival.

One of two things could happen, Aimee said.

The adenovirus could advance, and when it gets into his lungs, it’s not good.

Or, “by some miracle,” his immune system could rise up and fix it on its own.

“It’s this really fine balancing act,” Aimee said. “Where we are right now, it could go either way.”

She said it would be “extraordinarily helpful right now” to get the drug.

In the last week, Josh has gotten significantly worse.

“We are really getting to the edge of danger,” she said.

Here in Fredericksburg, support is pouring in for Josh.

At Hugh Mercer, Denise Phipps and Lisa Dingman’s first-grade classes made a get-well banner for their classmate.

And in addition to the emails and phone calls to Chimerix, there’s a Twitter campaign to get the company’s attention.

First-grader Jasmine Ross, 7,  helps decorate a banner for her fellow classmate, Joshua Hardy, 7.

First-grader Jasmine Ross, 7, helps decorate a banner for her fellow classmate, Joshua Hardy, 7.

In addition to calling and writing to Chimerix, Aimee is asking for prayers.

“Our faith in God has brought us to this point and will bring us through the whole thing,” she said.

“He needs to catch a break. He’s in a lot of discomfort right now.”


Read about Josh’s journey on his Caring Bridge website:

You can call Chimerix, the company who makes the drug Josh needs: 919/ 806-1074 or email Kenneth Moch is the company’s president.

To get in on the Twitter campaign, tweet @chimerix and use #savejosh.

Denise Phipps' and Lisa Dingman's first-grade classes at Hugh Mercer Elementary decorate a banner for their fellow classmate, Joshua Hardy,  7,  who recently relapsed in his fight against cancer. The banner will be delivered to Joshua at St. Jude's Children Hospital. / Photos by Autumn Parry

Denise Phipps’ and Lisa Dingman’s first-grade classes at Hugh Mercer Elementary decorate a banner for their fellow classmate, Joshua Hardy, 7, who recently relapsed in his fight against cancer. The banner will be delivered to Joshua at St. Jude’s Children Hospital. / Photos by Autumn Parry

Robyn Sidersky 540/374-5413