How did I miss this: more warning signs for TGN 1412


This time, Tegeneron has admitted to seeing “side effects in monkeys”:http://www.medindia.net/news/view_news_main.asp?x=8679.

bq. In a pre-clinical trial that involved animals, two monkeys have been reported to develop lymph node inflammation following injection of the experimental drug. The company in response to the above issue has however said that symptoms experienced by the man had no correlation with that documented in monkeys.

I find this an intriguing statement, given that the adverse drug reaction was essentially a super-charged inflammation. It gets better:

bq. The drug company had previously claimed that there had been no drug-related adverse effects. Furthermore, the study participants were told that there had been no instances of adverse effects in the prior tests. The side effect of the drug as seen in monkeys had been high enough to warrant monitoring of the immune system and function in human volunteers.

Say what?

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