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SYNERGEN'S PHASE III SEPSIS TRIAL SHOWS MORTALITY REDUCTION IN MOST SERIOUSLY ILL PATIENTS

 BRUSSELS, Belgium, March 23 /PRNewswire/ -- Charles J. Fisher, Jr., M.D., of The Department of Pulmonary and Critical Care Medicine, The Cleveland Clinic Foundation and Case Western Reserve University, presented today preliminary results of Synergen's (NASDAQ: SYGN) Phase III clinical trial of ANTRIL - (Interleukin-1 receptor antagonist or IL- 1ra) in patients with sepsis at the 13th International Symposium on Intensive Care and Emergency Medicine in Brussels, Belgium. The abstract is attached for your information.
 The study reported on a total of 893 patients who received ANTRIL or placebo at 63 investigative sites in eight countries. A comparison of treatment groups showed an increase in survival times in the groups treated with ANTRIL, but this result was not statistically significant when all patients were considered.
 A benefit of ANTRIL was observed in patients who were severely ill. In two-thirds of the patients (595 out of 893) who had the highest predicted risk of mortality, those treated with a high dose of ANTRIL had a 22 percent reduction in mortality compared to placebo.
 High Risk Treatment Groups
 Dose Placebo 1 mg/kg/hr 2 mg/kg/hr
 Day 28 88/197 74/198 70/200
 Mortality (45 percent) (37 percent) (35 percent)
 "A retrospective analysis of survival of these higher risk patients showed a benefit from treatment with ANTRIL that is significant at the level p=0.032, when you apply the same statistical method used to analyze the complete study," said Jon S. Saxe, president and chief executive officer of Synergen. Because the study reported today did not prospectively define which patients would benefit from treatment with ANTRIL, the company plans to conduct a follow-up double-blind, placebo- controlled trial to study sepsis patients who have a high risk of mortality. Saxe continued, "If the results stated above are reproduced in such a study, they would be statistically significant."
 Saxe also said, "The risk prediction method used in this study was developed by APACHE Medical Systems specifically to predict mortality in patients with sepsis and uses information that can readily be determined prior to treatment. We believe that this method also constitutes a powerful new diagnostic tool to help physicians predict which patients may benefit from treatment with ANTRIL."
 Synergen plans to file for marketing approval of ANTRIL in Europe later this year. The company is designing the next study and hopes to begin patient enrollment during the summer. The company does not currently expect to file for marketing approval in the U.S. until completion of this next study.
 Sepsis is the clinical complex of signs and symptoms that result from severe systemic infection. Interleukin-1 (IL-1) has been shown to be a major mediator of the inflammatory response of sepsis. ANTRIL is Synergen's recombinant interleukin-1 receptor antagonist product. Because ANTRIL blocks the action of IL-1, it is being tested as a new therapy for sepsis and other inflammatory disorders.
 Synergen is a biopharmaceutical company engaged in the discovery, development and manufacture of protein-based pharmaceuticals. The company's research is targeted towards products for inflammatory disorders and neurological diseases. The company is headquartered in Boulder, Colorado, with manufacturing operations in Boulder and Delaware, and business operations in the Netherlands and Japan.
 A Study Evaluating The Efficacy Of Human Recombinant Interleukin-1 Receptor Antagonist (IL-1ra) In The Treatment Of Patients With Sepsis Syndrome: Preliminary Results From A Phase III Multicenter Trial:
 C. Fisher Jr., M.D.; J.F. Dhainaut, M.D., Ph.D.; J. Pribble, Pharm.D.; W. Knaus, M.D.; and the IL-1ra Phase III Sepsis Syndrome Study Group; From the Department of Pulmonary and Critical Care Medicine, The Cleveland Clinic Foundation and Case Western Reserve University, Cleveland, OH (CJF); Service De Reanimation Medicale, Cochin Port Royal University, Paris, France (JFD); Synergen, Inc., Boulder, CO (JPP); ICU Research Unit, George Washington University Medical Center, Washington, DC (WAK).
 Abstract:
 Sepsis syndrome remains a significant cause of morbidity and mortality in critically ill patients. The pro-inflammatory cytokines tumor necrosis factor, interleukin-1 (IL-1), and interleukin-6 have been shown to be important mediators in the pathogenesis of sepsis syndrome and septic shock. Interleukin-1 receptor antagonist (IL-1ra) is a naturally occurring inhibitor of IL-1 which is produced by macrophages in response to IL-1, endotoxin, and other stimuli. The non-glycosylated human form of IL-1ra has been isolated, purified, and produced by recombinant DNA technology using Escherichia coli fermentation. In a previous, small, randomized, open-label, placebo-controlled, multicenter clinical trial, human recombinant IL-1ra was shown to reduce mortality in patients with sepsis syndrome and septic shock in a dose-dependent manner. To further define the efficacy of IL-1ra in patients with sepsis syndrome, we undertook a randomized, double-blind, placebo- controlled, multicenter clinical trial. At study entry, all patients had evidence of either hypotension and/or end organ dysfunction and were randomized to receive either an intravenous loading dose of IL-1ra 100 mg or placebo (vehicle) followed by a continuous 72 hour intravenous infusion of IL-1ra (1.0 mg/kg/hr or 2.0 mg/kg/hr) or placebo. Patient survival time was evaluated through Study Day 28. A total of 893 patients received IL-1ra or placebo at 63 investigative sites from eight countries. Treatment groups were well balanced at entry for predicted risk for mortality as determined by a risk prediction model developed independent of the clinical trial data base (N = 892, ANOVA, P = 0.85). A comparison of survival times did not reveal a significant difference among treatment groups in all patients (N = 893, Wilcoxon, P = 0.22) or in patients with shock at study entry (N = 713, Wilcoxon, P = 0.23). An analysis of outcome as a function of predicted risk for mortality suggested the survival benefit with IL-1ra treatment increased with increasing severity of illness. In patients with a predicted risk for mortality greater than or equal to 24 percent (N = 595), those patients receiving IL-1ra 2.0 mg/kg/hr had a 22 percent reduction in mortality compared to patients receiving placebo.
 Patients with Predicted Mortality +/- (N equals 595)
 Placebo IL-1ra 1.0 mg/kg/hr IL-1ra 2.0 mg/kg/hr
 No. of deaths 88/197 74/198 70/200
 Mortality rate
 (expressed as
 percent) 45 37 35
 A retrospective analysis demonstrated a survival benefit with IL-1ra treatment (N equals 595, Wilxocon, P equals 0.032). We conclude IL-1ra appears to provide a survival benefit in patients with sepsis syndrome as a function of increasing predicted risk for mortality.
 -0- 3/23/93
 /CONTACT: Paul Laland, media, 303-541-1325, or Debra Bannister, investor, 303-938-6242, both of Synergen/
 (SYGN)


CO: Synergen Company ST: Colorado IN: MCT SU: PDT

TS -- NY010 -- 8617 03/23/93 11:06 EST
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