A precedent for TGN 1412?

Derek Lowe, pharmaceutical chemist, wonders if there was a “precedent”:http://pipeline.corante.com/archives/2006/03/20/tng1412_was_there_a_warning.php for the TGN 1412 fiasco. Essentially the story goes that a company presented results last year on an antibody that affects similar biological pathways (specifically, TGN 1412 was supposed to bind to a protein called CD28 and the other compound, I think, was supposed to bind to another protein in the same biological process) and caused a lot of problems (though not as severe as TGN 1412). If those results were well known, an ethics board might have required that Parexel (the clinical research organization conducting the trial) to dose patients in a more scattered fashion rather than all of them close to the same time.

In the meantime, researchers are “investigating what went wrong”:http://go.reuters.com/newsArticle.jhtml?type=scienceNews&storyID=11578259&src=rss/scienceNews and may point out some of the inadequacies of our animal modeling, at least when it comes to these particular pathways.

And, as for the volunteers involved, according to the Reuters report, two are still critically ill, one is one on organ support, and the other three are recovering.

What curve balls will be thrown at us next?


2 Responses

  1. What has happened to the trial and the people? The pace with which it was hushed up is frightening as all recombinant technology is simillarly threatening.

  2. I don’t see this being hushed up, though who knows what details we haven’t heard yet. Last I heard, two people were still in comas and requiring organ support of some kind (either dialysis or respirator or something like that) and one or two others are close to being well enough to discharge into the care of their families.

    There’s also the news that this antibody caused some problems in primate testing, and also the German inquiry into Tegeneron, the sponsor behind the drug.

    What I have not heard is whether Parexel’s role in this is being scrutinized (I’m sure it will be soon if it isn’t already, as the investigator at the CRO apparently had some latitude.)

    I also don’t think that recombinant technology, or monoclonal antibody development, or other technologies are at risk, save those that target CD28 (as TGN 1412 did). What will probably happen is more regulation and scrutiny at the beginning of clinical development (human testing).

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