Carter Grodi has been allergic to peanuts his whole life.
"He was 1 years old when I gave him a Ritz cracker, and he started coughing and having trouble breathing. I immediately took him to a pediatrician," said Carolee Grodi, Carter's mom.
From that point on, when peanuts were around, Carter would always have to watch what he ate, or whom he sat next to in the school cafeteria in his hometown of Ocala. At birthday parties, he couldn't eat cakes made by Publix, because the grocer bakes cakes on the same surfaces where they make other products that contain peanuts. The list of foods he can't eat is fairly long.
But thanks to a new oral immunotherapy drug being tested in a clinical trial at the University of South Florida, Carter, now 16, can eat peanut M&Ms for the first time in his life.
The drug helps build tolerance to the allergy in the body, which could potentially lessen the severity of symptoms during an emergency, researchers say.
USF participated in the successful clinical drug trial for children with life-threatening peanut allergies. The PALISADE study published in the New England Journal of Medicine this week shows that due to the positive results in the trial so far, it is one step closer to becoming the first FDA-approved treatment for protecting against accidental, and possibly dangerous, exposure to peanuts in children who are allergic to them.
"This is the largest food allergy study done to date," said Dr. Thomas Casale, an allergist and immunologist with USF Health. "It is very likely this drug will be approved by the FDA, given the results we've had so far."
About 2.5 percent of children in the United States have been diagnosed with a peanut allergy, according to the American College of Asthma, Allergy and Immunology. The number continues to rise among adolescent populations.
USF is one of two sites in Florida that tested the new oral immunotherapy for children, known as AR101. The drug was developed by Aimmune Therapeutics and manufactured in Clearwater. Casale is a member of the company's scientific advisory board.
AR101 contains precisely measured amounts of powdered peanut protein in pull-apart capsules, which was mixed in food and administered to patients with peanut allergies. These patients were monitored by physicians over the course of more than two years, as the amount of peanut was gradually increased.
When Carter began the study, his body would begin to show allergic reactions when he was ingesting the equivalent of just 1/10th of a peanut. But over time, his tolerance grew to be three to four whole peanuts.
USF was one of 66 sites across the United States, Canada and Europe that tested the drug. It isn't meant to "cure" a patient of their allergy, but to provide a safety buffer in case of an accidental exposure, Casale said.
"It's not like these people can go to a Tampa Bay Rays game and eat a bunch of peanuts," Casale said. "But they are protected from accidental exposure."
The only way to prevent allergic reactions to peanuts and most other food allergies currently is to avoid them. Carter and his family carry an auto-injectable epinephrine shot in case of emergencies, which can be costly to purchase. But it is the only emergency tactic available to combat symptoms such as hives, the swelling of the tongue and throat, difficulty breathing and abdominal cramps.
Aimmune Therapeutics plans to file for FDA approval before the end of this year. If approved, the drug could be available for use in children ages 4 to 17 by late 2019.
"We're still on new ground with this. We don't know if patients need to take the drug every day once they meet the maintenance dose after six months, or once a week, or a few times a month," Casale said. "We don't know if we can give them a peanut product like a Reese's Cup. But this is the first step."
USF Health will continue to participate in ongoing studies on dosing of AR101 and long-term safety in immunotherapy, he said.
For Carter and his family, the trial offers a glimmer of hope for the future, mom Carolee Grodi said.
"It's been hard work to manage," she said, adding she worked with the school district for years to manage her son's allergy. "Some people just don't understand or take it the wrong way. They're offended that he can't eat their food. There were times when he was a kid, that his friends had to educate their own parents. They'd tell their moms not to pack peanut butter and jelly sandwiches so that they could still sit next to Carter at lunch."
Contact Justine Griffin at firstname.lastname@example.org. Follow @SunBizGriffin.