I'm Dr. Joshua Schwimmer, a nephrologist and internal medicine physician in New York City. • Kidney Notes was the first active nephrology blog. (Trivia: Kidney Notes is so old that the National Library of Medicine still uses it as an example of how to formally cite blogs.) • Professionally, you can find me at Kidney.nyc. • Kidney Notes is for educational purposes only, not medical advice. Consult qualified health care professionals. See disclaimer.

Monday, March 20, 2006

An Update on the Tragic TGN 1412 Trial

From Health Care Renewal:
Our most recent post on the lack of transparency in the trial run by Parexel of TGN 1412, a drug developed by TeGenero, which left all six participants in intensive care with multi-organ system failure, was here.

This trial has generated tremendous media attention. Thus, we now know a bit more about it, but still not much.

According to TeGenero's website, the drug TGN 1412 is a monoclonal antibody that targeted the CD28 receptor on T-lymphocytes. The drug is not meant to destroy T-lymphocytes, but rather to activate the CD28 receptor. According to TeGenero, the TGN 1412 leads to "pronounced T-cell activation and expansion." Thus, unlike some other monoclonal antibodies used to treat cancer, this drug was meant to change the settings, as it were, of the patient's immune system. This was thus a novel therapy, and hence one whose results might have been unpredictable.
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