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January 19, 2006
Genentech stops a clinical trial of an allergy reaction drug
source: truthabouttrade.org
Genentech, Inc., recently ranked the #1 company to work for by Forbes magazine, stopped a clinical trial of a drug it hopes can be used to prevent peanut-allergy reactions, citing safety concerns not with the drug itself but with an allergy test.
The South San Francisco, Calif., biotechnology company said two children in the 150-person trial experienced "severe hypersensitivity reactions" when given a trace amount of peanut protein, an initial step designed to gauge the severity of a patient's allergies. Neither child had received the drug, called Xolair, the company said. Xolair is on the market, approved as a treatment for allergic asthma.
"We had always been very nervous about that study," said Susan Desmond-Hellmann, head of product development for Genentech. "We are not going to do that anymore."
Cancellation of the Xolair trial means that an approved treatment for peanut allergy remains years away at the earliest. Dr. Desmond-Hellmann said Genentech may explore the possibility of moving straight to a large-scale trial that wouldn't involve a peanut "challenge," as the allergic-reaction test is called. Instead, such a trial might track volunteers over an extended period of time, to determine if those receiving Xolair experienced fewer accidental peanut reactions than those taking a placebo.
"It's going to take a long time, and it's going to be hard work, but it's better than exposing someone we know to be allergic" to peanuts, Dr. Desmond-Hellmann said.
The setback is the latest delay in a long and fitful effort to find a drug that can blunt the serious consequences of peanut allergy. The condition, which affects an estimated 1.5 million Americans, can lead to life-threatening anaphylactic shock if allergic individuals ingest even a trace amount of peanut flour or oil. In November, a 15-year-old Canadian girl with the allergy died reportedly after a kiss from her boyfriend, who had earlier eaten a peanut-butter snack.
Posted by David at January 19, 2006 1:41 AM