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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?


To: StockDoc who wrote (9310)3/21/1999 2:25:00 PM
From: Cacaito  Read Replies (2) | Respond to of 17367
 
Kindly go back to the past (past posts I mean), and find that meningitis is not the same as meningococcemia, mortality in septic shock is in the 20% to 60% range, posts 8220, 8235 (Spain),
posts 7565, 7560 (Ducth) 8599 (meta-analysis), 8216 (France), and
8364 (UK).

Peritoneal Ventilation? nobody will fill my belly with gas, it is already full of it. Anyway that should be a poor country, Extracorporeal Membrane Oxygenation and Dyalisis plus heat filtration could accomplish all this without extra gas in the bowels.

My tail (my calculations)new version:

Total of 400 subjects (take it easy).

Two arms (george must be please)and double stratification according to
Glasgow scores.

1.Low Glasgow Score:

N 100 placebo, mortality 20% = 20 deceased
N 100 Bpi treated, mortality 8% = 8 deceased

2.High Glasgow score:

N 100 placebo, mortality 40% = 40 deceased
N 100 Bpi treated, mortality 15% = 15 deceased

Total mortality = 83

New company Headquarters La Havana, no taxes, only Cigars for profits.



To: StockDoc who wrote (9310)3/21/1999 4:00:00 PM
From: Cacaito  Read Replies (2) | Respond to of 17367
 
StockDoc, one will need 20,000 patients, to prove a 10% improvement in the Bpi arm if one assumes a 10% mortality. 10% improvement means:
placebo 10%, bpi 9% (1% is the 10% improvement of 10%).



To: StockDoc who wrote (9310)3/21/1999 7:32:00 PM
From: Robert S.  Read Replies (3) | Respond to of 17367
 
StockDoc...

By the way, what's the thinking on this
board about the apparent efficacy of protein C, antithrombin III and, maybe,
activated protein C (Baxter, Genzyme, and Eli Lilly) in bacterial sepsis?


I too follow with interest the potential therapeutic treatments you listed; the abstract below illustrates the promising potential:

Intensive Care Med 1998 Jul;24(7):663-72

Antithrombin III in patients with severe sepsis. A randomized, placebo-controlled, double-blind
multicenter trial plus a meta-analysis on all randomized, placebo-controlled, double-blind trials
with antithrombin III in severe sepsis.

Eisele B, Lamy M, Thijs LG, Keinecke HO, Schuster HP, Matthias FR, Fourrier F, Heinrichs H, Delvos U

Clinical Research Department, Centeon Pharma GmbH, Marburg, Germany. bernd.eisele@solvay.com

OBJECTIVES: To evaluate the safety and potential efficacy of antithrombin III (AT III) in reducing mortality in patients with severe sepsis. DESIGN:
Prospective, randomized, placebo-controlled, double-blind, phase II, multicenter, multinational clinical trial. SETTING: Seven academic medical center
intensive care units (ICU) in Belgium, Denmark, the Netherlands, Norway and Sweden. PATIENTS: 42 patients with severe sepsis who received standard
supportive care and antimicrobial therapy, in addition to the administration of AT III or placebo. INTERVENTIONS: Patients received either an intravenous
loading dose of 3000 IU AT III followed by a maintenance dose of 1500 IU every 12 h for 5 days or equivalent amounts of placebo. MEASUREMENTS
AND RESULTS: All patients were evaluated for safety and for 30-day all-cause mortality. CONCLUSIONS: The administration of AT III was safe and
well-tolerated. It was followed by a 39 % reduction in 30-day all-cause mortality (NS). The reduction in mortality was accompanied by a considerably shorter
stay in the ICU. Patients treated with AT III exhibited a better performance in overall severity of illness and organ failure scores (Acute Physiology and Chronic
Health Evaluation II, multiple organ failure, organ system failure), which was noticeable soon after initiation of treatment. Patients treated with AT III
demonstrated a better resolution of pre-existing organ failures and a lower incidence of new organ failures during the observation period. A meta-analysis
comprising this and two other double-blind, placebo-controlled trials with AT III with a total of 122 patients suffering from severe sepsis confirms the positive
trend. The results of the meta-analysis demonstrate a 22.9 % reduction in 30-day all-cause mortality in patients treated with AT III. Although still too small to
be confirmative, the meta-analysis clearly points to the fact that a sufficiently powered phase III trial is warranted to prove whether AT III has a beneficial role
in the treatment of severe sepsis.

Publication Types:

Clinical trial
Clinical trial, phase ii
Meta-analysis
Multicenter study
Randomized controlled trial

Comments:

Comment in: Intensive Care Med 1998 Jul;24(7):649-50

PMID: 9722035, UI: 98387490