ABTI main problem was the very poor clinical science behind.
Another problem was the concept itself, it was like a vaccine (the
company called it an immunomodulator).
Be worry of molecules that do all kinds of jobs (ABTI's glucan was
good for everything, like antioxidants).
Check The ABTI thread (is no too long) and I predicted the first debacle
and the second one.
Subset data is poor when one does not plan for it in the phase III
trial, is a secondary finding (after massage of data to please someone) and especially
when the company wants to please markets.
Amylin is having some problems with this, but they have being doing
very good research, their product is in a very complex disease, and
they just keep getting poor results, I would not bet on it.
Xoma did a phase II in trauma and found a subset to work at (to decrease
pneumonia and ARDS )in the phase III this is the appropriate way (but it does not assure good
results). but is still non focus patients are trauma first, and infections
could be of any kind. Trauma of the head, chest, abdomen ?
Hemorrhage from one leg, from anywhere? dying from lack of blood vs from
infections, Infections complication like pneumonia vs probably infectious ARDS or
none infectious type post trauma ARDS? Gram positive vs Gram negative?
Xoma,s exploratory phase II in abdominal infections complications is
a much better model, it is more focus to the gram-negative infections,
the subjects are sicker and older, and the problem is mainly infections
This model I find more appropriate than the trauma one.
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