Now Genentech has announced its cancellation of a peanut-allergy trial for Xolair. The trial was halted because of side-effects of the peanut antigen challenge in the control group. This is different from the typical situation in which a trial is halted because of a problem with the medication. Here, the problem is that the underlying allergy condition is so dangerous that the control group was at risk. From the Journal:
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.
Does Genentech know what it’s doing?