GTC Biotherapeutics (fka GTCB)

[DewDiligence]

The ART-123 mortality results were not especially impressive (IMO) and were not even close to being statsig. The excerpt below is from the ART-123 paper in J Thromb Haemost 2007; 5: 31–41 (the paper cited by vinmantoo):

>>
The mortality rates for the ART-123 and heparin groups were 17.2% and 18.0% (difference - 0.8%; 95% CI -14.2 to 12.5) respectively in patients with DIC associated with hematologic malignancy;

…and were 28.0% and 34.6% (difference -6.6%; 95% CI -24.6 to 11.3) respectively in patients with DIC associated with infection [i.e. sepsis].
<<

The study treated 234 patients with DIC caused by either cancer or sepsis; hence the two sets of figures above.

This study is somewhat hard to interpret in that heparin—which is no longer the considered the standard of care for DIC— was used in the control arm. Nevertheless, I think it’s fair to say that the mortality results are at best tepid, even in the sepsis subgroup.

Although the mortality p-values are not shown, you can get a rough measure of the degree to which the data missed statistical significance by examining the upper bound of the 95% confidence intervals, which were 12.5% and 11.3% for the cancer and sepsis subgroups, respectively. For the mortality results to have been statsig, the upper bounds of these confidence intervals would have had to be less than zero, so it’s clear that these data were not close to being statsig.

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