Biotech Values

[DewDiligence]

Genentech Stops Trial on Concerns
Over Safety of Peanut-Allergy Test

[For background on this program, please see #msg-5951137.]

http://online.wsj.com/article/SB113737301838547294.html

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By DAVID P. HAMILTON
Staff Reporter of THE WALL STREET JOURNAL
January 16, 2006

Genentech Inc. 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.

Several years ago, a drug called TNX-901 from a Houston biotechnology company called Tanox Inc. appeared to reduce peanut sensitivity in a similar clinical trial of allergic individuals. But Tanox's corporate partners, Genentech and Novartis AG, objected to continued development of the drug, wanting to focus on Xolair instead. After years of legal tussles, Tanox agreed to shelve TNX-901 in early 2004. The decision to shelve Tanox was the subject of a page-one article last year in The Wall Street Journal.

The three companies next agreed to test Xolair as a possible peanut-allergy treatment. The clinical trial was similar to the earlier test of TNX-901, and some researchers had anticipated that it might produce results later this year. Volunteers, however, were slow to sign up, Genentech officials said.
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