Most ClinPage readers are familiar with the ill-fated TeGenero trial of TGN1412, a Phase I study that went awry earlier this year.

The BBC is revisiting the matter. The most debilitated patient is recovering nicely, though his ordeal sounds chilling. No major organ system was unaffected.

Here’s a quote from the BBC:

“Ryan Wilson, 20, from London was the most seriously ill of the six men whose heads and bodies swelled up following injections of TGN1412 in March. Mr. Wilson had to have fingertips and all of his toes amputated and it is not clear what his future health will hold. The drug may have left him prone to infections and cancer.”

His face looks surprisingly healthy, but there’s another photograph of his hands. Some ClinPage readers won’t want to check out the link to the BBC above. Trust us. Several fingertips are now black, and it’s not clear if those are finger-prostheses or scar tissue or both. We are grateful for our own ten spry fingers today.

Policy wise, the TGN1412 matter continues to simmer.

Unanswered questions include whether a catastrophic “cytokine storm” could reasonably have been anticipated, and whether all of the patients should have received the drug in a short, 20-minute interval. Despite extraordinary amounts of publicity to the TGN1412 issue in England, the saga has resulted in no formal changes to clinical trial procedures in the EU. A few experts can be reliably produced to issue proclamations that the rules should change, but so far they have not.

The manufacturer of the compound (Boehringer-Ingelheim) and the contract research organization running the trial (Parexel) have so far been able to clear their names. Most of the blame has landed on TeGenero. It was a spinout from the Medical School of the University of Wurzburg. Now the company is in bankruptcy. But just this week, the ever handy Wikipedia entry notes, an anonymous German investor hopes to revive TeGenero.