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Phase II trial with IgM Concentrate completed in patients with severe community acquired pneumonia (sCAP) requiring mechanical ventilation
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Encouraging trend in reducing duration of ventilation as well as mortality
DREIEICH, Germany I June 30, 2015 I Biotest announces results of the phase II trial with IgM Concentrate (IgM enriched immunoglobulin preparation). The randomized, double-blind, placebo-controlled phase II trial was performed in 160 hospitalised patients with severe community acquired pneumonia (sCAP), a condition that has a high potential of developing into a sepsis. This patient population has a high mortality rate and comprises severely ill patients which are in need of intensive care. The study was conducted in Germany, Spain and UK.
After consulting experts and authorities, Biotest has chosen a new approach by using ventilator free days (VFDs) as primary endpoint taking into consideration that the relatively small sample size would not suffice to show significant differences in mortality. Therefore, 28-day mortality was selected as one of the secondary endpoints as recommended by the sepsis guideline of the European Medical Agency (EMA). The mortality rate in this indication is high, depending on age and treatment conditions.
The severity of the disease in the treated patients was confirmed by validated disease severity scores. The treatment with IgM Concentrate showed a trend in reducing ventilator free days and 28-day mortality.
While the study results were not statistically significant, the observation of a 20 % relative reduction in mortality rate is encouraging, keeping in mind the low patient number in this trial and the known high failure rate with other investigational compounds in sepsis-like indications.
Overall, the tolerability of IgM Concentrate was good and the safety profile as expected in the treated severely ill population.
Coordinating Investigator Prof. Dr. Tobias Welte (Head of Clinic for Pneumology, Hannover Medical School) stated, “Especially the observed trend in reduction in mortality is a positive signal for this compound in sCAP.”
Further analyses of the study data will be used to prepare the next phase of clinical development and to identify those patients who potentially would benefit the most of an IgM therapy.
About CIGMA (phase II trial in sCAP)
A randomized, double-blind, placebo-controlled, multicenter, parallel-group, adaptive group-sequential phase II study with a total of 160 patients, to determine the efficacy and safety of IgM Concentrate as an adjunctive treatment in Severe Community Acquired Pneumonia.
The purpose of this study was to determine whether the adjunctive therapy to standard antibiotic treatment with IgM Concentrate is safe and effective in decreasing number of the days patients require endotracheal ventilation due to severe community acquired pneumonia (sCAP).
A total of 160 patients were treated in Germany, Spain and UK.
ClinicalTrials.gov Identifier: NCT01420744
About severe community acquired pneumonia (sCAP)
Severe community acquired pneumonia (sCAP) is usually defined as pneumonia acquired outside the hospital that requires intensive medical care. Mortality of sCAP patients admitted to the intensive care unit is high, depending on time and admission of the patient and has not improved much in recent years.
About IgM Concentrate
IgM Concentrate is a new IgM enriched immunoglobulin preparation derived from human plasma for the treatment of severe community acquired pneumonia (sCAP). IgM Concentrate acts through a wide range of mechanisms interfering with pathophysiological processes which otherwise could lead to severe respiratory disturbances, severe sepsis, multiorgan failure and ultimately death of the patient. Besides neutralisation of bacterial endotoxin and exotoxin, IgM mediates increased recognition of pathogens by certain immune cells and promotes their destruction. In addition, IgM can rebalance excessive immune responses and possesses anti-inflammatory properties.
SOURCE: Biotest
Post Views: 47
-
Phase II trial with IgM Concentrate completed in patients with severe community acquired pneumonia (sCAP) requiring mechanical ventilation
-
Encouraging trend in reducing duration of ventilation as well as mortality
DREIEICH, Germany I June 30, 2015 I Biotest announces results of the phase II trial with IgM Concentrate (IgM enriched immunoglobulin preparation). The randomized, double-blind, placebo-controlled phase II trial was performed in 160 hospitalised patients with severe community acquired pneumonia (sCAP), a condition that has a high potential of developing into a sepsis. This patient population has a high mortality rate and comprises severely ill patients which are in need of intensive care. The study was conducted in Germany, Spain and UK.
After consulting experts and authorities, Biotest has chosen a new approach by using ventilator free days (VFDs) as primary endpoint taking into consideration that the relatively small sample size would not suffice to show significant differences in mortality. Therefore, 28-day mortality was selected as one of the secondary endpoints as recommended by the sepsis guideline of the European Medical Agency (EMA). The mortality rate in this indication is high, depending on age and treatment conditions.
The severity of the disease in the treated patients was confirmed by validated disease severity scores. The treatment with IgM Concentrate showed a trend in reducing ventilator free days and 28-day mortality.
While the study results were not statistically significant, the observation of a 20 % relative reduction in mortality rate is encouraging, keeping in mind the low patient number in this trial and the known high failure rate with other investigational compounds in sepsis-like indications.
Overall, the tolerability of IgM Concentrate was good and the safety profile as expected in the treated severely ill population.
Coordinating Investigator Prof. Dr. Tobias Welte (Head of Clinic for Pneumology, Hannover Medical School) stated, “Especially the observed trend in reduction in mortality is a positive signal for this compound in sCAP.”
Further analyses of the study data will be used to prepare the next phase of clinical development and to identify those patients who potentially would benefit the most of an IgM therapy.
About CIGMA (phase II trial in sCAP)
A randomized, double-blind, placebo-controlled, multicenter, parallel-group, adaptive group-sequential phase II study with a total of 160 patients, to determine the efficacy and safety of IgM Concentrate as an adjunctive treatment in Severe Community Acquired Pneumonia.
The purpose of this study was to determine whether the adjunctive therapy to standard antibiotic treatment with IgM Concentrate is safe and effective in decreasing number of the days patients require endotracheal ventilation due to severe community acquired pneumonia (sCAP).
A total of 160 patients were treated in Germany, Spain and UK.
ClinicalTrials.gov Identifier: NCT01420744
About severe community acquired pneumonia (sCAP)
Severe community acquired pneumonia (sCAP) is usually defined as pneumonia acquired outside the hospital that requires intensive medical care. Mortality of sCAP patients admitted to the intensive care unit is high, depending on time and admission of the patient and has not improved much in recent years.
About IgM Concentrate
IgM Concentrate is a new IgM enriched immunoglobulin preparation derived from human plasma for the treatment of severe community acquired pneumonia (sCAP). IgM Concentrate acts through a wide range of mechanisms interfering with pathophysiological processes which otherwise could lead to severe respiratory disturbances, severe sepsis, multiorgan failure and ultimately death of the patient. Besides neutralisation of bacterial endotoxin and exotoxin, IgM mediates increased recognition of pathogens by certain immune cells and promotes their destruction. In addition, IgM can rebalance excessive immune responses and possesses anti-inflammatory properties.
SOURCE: Biotest
Post Views: 47
