Replies to post #2529 on GTC Biotherapeutics (fka GTCB)

[Lewis R Goudy]

Can someone address the negative Address trial results?

I don't have a NEJM subscription. Can somebody please
complete the last sentence of this 100 word excerpt:

To the Editor: In the article by Abraham et al. (Sept. 29 issue),1 the ADDRESS (Administration of Drotrecogin Alfa [Activated] in Early Stage Severe Sepsis) trial showed no benefit of drotrecogin alfa (activated) (DrotAA) in patients with severe sepsis and a low risk of death (defined by single-organ failure or an Acute Physiology and Chronic Health Evaluation [APACHE II] score <25).2 In contrast to the prematurely terminated PROWESS (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis) trial,3 the ADDRESS study showed higher mortality in its subgroup of patients treated with DrotAA who had an APACHE . . .
http://content.nejm.org/cgi/content/extract/354/1/94

The Google hit for the following extract contained the text
"It was also disconcerting that the results of the ADDRESS trial failed to ... The ADDRESS trial confirms the lack of efficacy in patients with APACHE II ..."

Sepsis, severe sepsis, and septic shock represent a spectrum of increasingly severe diseases that result from serious infection and the body's response to microbiologic invasion. Population data suggest that 750,000 cases of severe sepsis occur in the United States annually; this illness is responsible for as many deaths as acute myocardial infarction (215,000, or 9.3 percent of deaths from all causes).1,2,3 Almost every discipline in medicine must deal with this disease, from neonatology to orthopedic surgery to emergency medicine, though much of the management is performed by critical care physicians in intensive care units.
http://content.nejm.org/cgi/content/extract/353/13/1398

This guy blames the negative results on everything in sight
except Xigris. I wish GTC had a spinmeister of such stature:
http://www.medscape.com/viewarticle/501904

Abraham, et al. 9/29/05:
Conclusions The absence of a beneficial treatment effect, coupled with an increased incidence of serious bleeding complications, indicates that DrotAA should not be used in patients with severe sepsis who are at low risk for death, such as those with single-organ failure or an APACHE II score less than 25.
http://content.nejm.org/cgi/content/short/353/13/1332

This all seems to underscore the upshot of the read me post,
that if another drug stands in Atryn's way in sepsis it won't
be Xigris.