GTC Biotherapeutics (fka GTCB)

[dewophile]

jessellivermore et. al.,
here's a link to the JAMA piece:

http://scalpel.stanford.edu/articles/AT3.pdf

the comments are helpful..they reference mulitple phase II designs in ATIII that showed promise, cite issues related to study design/patient popultaion (higher than expected ATIII levels at baseline), lower than expected therapeutic levels of ATIII achieved with dosages used (which were arbitrary and NOT titrated to ATIII consumption/levels in individual patients), and the statistically significant finding in the no-heparin group. While i am wary of data mining and subgroup analyses in general, the no heparin group was defined a priori and has a biologic rationale for undermining ATIII efficacy (interfereing with glycosaminoglycan binding, etc.)

I actually come away thinking there is a good chance for success in the DIC trial, especially with careful design, titration of dose, omitting heparin, and including long-term follow up data (which showed the more dramatic differences between study groups)

I am not in the critical care field, but I am also encouraged by fact ATIII is already used in this setting in many places where it is more readily available