Xolair and clinical trials in South Florida

Posted on: Tue, 05/18/2004 - 10:42pm
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[url="http://www.sptimes.com/2004/05/19/Hillsborough/Test_to_look_at_drug_.shtml"]http://www.sptimes.com/2004/05/19/Hillsborough/Test_to_look_at_drug_.sht...

Test to look at drug for peanut allergy
USF and Tampa General are among those working to test Xolair's effectiveness on a potentially deadly allergy.
By LISA GREENE, Times Staff Writer
Published May 19, 2004

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TAMPA - In most ways, Matt Sox is a perfectly healthy 13-year-old. He loves flag football, karate and hiking.

But everywhere the New Tampa teenager goes, an emergency shot and dose of allergy medicine go with him. He's allergic to peanuts, and ingesting even a tiny amount can make his throat tighten, his lips swell and his breathing difficult.

Without speedy treatment, he could die.

His mother, Jill Sox, wishes there were a way to lessen his symptoms, instead of just drugs to treat a life-threatening emergency.

That's what doctors at the University of South Florida and Tampa General Hospital are working on. USF/Tampa General is one of 20 sites in the country testing whether Xolair, a drug approved last year to treat asthma, also helps peanut allergy.

But to see whether the drug really works, scientists must ask patients to do what they most try to avoid:

Eat peanuts.

Or, at least, peanut flour. They'll start with a tiny amount - 5 milligrams, about a 50th of one peanut. And study volunteers will be at Tampa General, where researchers will treat any reaction.

"They might feel very uncomfortable, but it's done in a way that ensures their safety," said Dr. Dennis Ledford, professor of medicine in USF's Division of Allergy and Immunology and the leader of the local clinical trial.

Strange as it might sound, there's no other way to see whether the drug works, Ledford said.

Studies of allergies often expose people with an allergy, such as hay fever, to the allergen, said Ledford and Dr. Stephen Wasserman, professor of medicine at the University of California at San Diego and a former president of the American Academy of Allergy, Asthma & Immunology.

The difference: Those volunteers have milder symptoms such as sneezing, not labored breathing or potentially deadly shock.

Peanut allergies provoke among the most severe reactions known, killing 50 to 100 Americans a year. The 1.5-million Americans who are allergic are so sensitive that some school lunchrooms have banned peanut butter, and many airlines no longer serve peanuts.

But Wasserman said scientists can't measure how well Xolair works without first seeing exactly how much peanut provokes a reaction.

"Many allergies do tend to wane with time," he said. "You have to verify they're still allergic."

Similar studies in the past have involved exposing allergic volunteers to insect stings, Wasserman said.

Ledford worries about finding volunteers.

"The concern is that we're going to have a lot of trouble recruiting patients," he said.

But Wasserman said allergy sufferers may step forward.

"If you're a patient with a life-threatening illness, you might be quite willing to undergo some risk," he said.

Volunteers will be exposed to tiny amounts of peanut flour, increased slightly until they react. Then they will be treated for several months, either with Xolair or a dummy pill, then tested again to see whether their symptoms have changed.

The study is being sponsored by Genentech, which co-markets Xolair with Novartis Pharmaceuticals. But Ledford said the company will not influence the results, and he expects the outcome to be published whether the drug is effective or not.

Scientists have high hopes for the drug. A study last year on a similar drug showed it lessened symptoms, but work on that drug has been delayed by a court fight over its ownership.

Meanwhile, Jill Sox carries emergency drugs and watches over Matt and his younger brother, Mark, who also has the allergy.

"There are no peanut products allowed in this house," she said. "Period."

The boys' symptoms are so severe that Sox has doubts about whether she would allow them in the trial. But she's still hoping the drug will help.

"It's hard to fathom," she said. "It's amazing how powerful an object as small as a peanut can be."

VOLUNTEERS NEEDED
The University of South Florida and Tampa General Hospital are seeking patients with peanut allergy who are between 6 and 75 to participate in a study on whether an asthma drug lessens symptoms. For more information about the study, call (813) 631-4024, ext. 201.

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