- The Washington Times - Monday, March 10, 2003

DENVER, March 10 (UPI) — A new medication can help save lives by protecting individuals who are allergic to peanuts from suffering severe reactions, study results released Monday conclude.

Because the medication has important clinical implications, the researchers said they decided to release their findings several days before publishing them in the March 14 issue of The New England Journal of Medicine.

The researchers, led by Dr. Donald Leung of the National Jewish Medical and Research Center in Denver and Dr. Hugh Sampson of Mount Sinai School of Medicine in New York, reported they have formulated a medication containing the antibody that decreases hypersensitivity to peanuts. The medication, called TNX-901, blocks a molecule called IgE, which triggers allergic reactions.

"This is a very important study," Leung said. "A large majority of patients can be able to eat their next meal without fear" of accidental ingestion of peanuts.

In the study, 82 people ranging in ages from 12 to 60 and with severe peanut allergy were given four injections once a month, either of TNX-901 or a placebo. They also administered the injections at dosage levels of either 300 or 450 milligrams.

Before the study, each patient was exposed, under clinical surveillance, to increasing doses of peanut flour to establish his or her peanut sensitivity. IgE blood levels also were measured before treatment began and periodically throughout the study.

Two to four weeks after the final injections, patients underwent a second peanut exposure test.

Results showed the higher the dose of the antibody, the lower the sensitivity to peanuts. Nearly a quarter of the patients receiving the 450 milligram dose of TNX-901 were able to consume 24 peanuts with no reaction.

Researchers report a few patients still reacted to peanuts after their injections, but their reactions were milder compared with those before treatment and on average, individuals were able to eat more peanuts without any side effects.

Current treatment for peanut allergy involves shots of the drug epinephrine after exposure. Some patients are so sensitive to peanuts that any peanut product touching their tongue can cause their throat to swell shut and suffocate them. However, Sampson said, most patients do not receive epinephrine shots at the time of exposure, which typically occurs in public or social settings, such as restaurants and parties.

The new drug could be taken preventively, and although it is not a cure for the peanut allergy, it could reduce the risks of accidental exposure — a particular benefit for children who might not be aware they are allergic, Sampson said.

"That's what makes this particular study so exciting," he said. "One of the biggest problems we have is we cannot predict who will have a severe reaction."

Sampson said about 1.1 percent of the U.S. population, or about 3 million people, suffer from peanut allergies.

"Peanuts commonly appear in unexpected places," said Anne Munoz-Furlong, founder of the Food Allergy and Anaphylaxis Network.

"There are instances when peanuts are undeclared, she said, either on food labels or on menus or in private social gatherings. Even frying with peanut oil is a problem, she explained.

"This study is the first real hope for people with peanut allergies," Munoz-Furlong said, "providing a safety net for accidental ingestion. This study is not about molecules. It's about patients and the potential impact on the quality of life on patients."

Leung said TNX-901 has been fast-tracked at the Food and Drug Administration for potential approval. Clinical trials continue and there is a possibility the drug could be used to prevent immunological reactions to other types of foods, he said, adding he would like to see the drug tested on younger children, who are quite susceptible to accidental peanut ingestion.

(Reported by Katrina Woznicki, UPI Science News, in Washington)

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