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Favourable new data of phase II trial with IgM Concentrate in patients with severe Community Acquired Pneumonia (sCAP) published at ISICEM Symposium
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Strong data justifies phase III development
DREIEICH, Germany I March 16, 2016 I Biotest announces further results of a phase II trial with IgM Concentrate (IgM enriched immunoglobulin) in subgroups at the ISICEM Symposium in Brussels (International Symposium on Intensive Care and Emergency Medicine). The randomized, double-blind, placebo-controlled phase II trial (CIGMA trial) was performed in 160 hospitalised patients with severe community acquired pneumonia (sCAP).
Community acquired pneumonia (CAP) continues to be a leading cause of death worldwide. 10% of hospitalized patients with community acquired pneumonia develop a severe form (sCAP) that requires intensive medical care. Despite treatment with antibiotics patients with sCAP still have a high mortality of 23-58% due to severe infections. IgM Concentrate is investigated as an add-on therapy in addition to standard antibiotic therapy to reduce mortality. During hospitalisation the severity of infection is constantly monitored by inflammation markers.
In the phase II study patients were randomized to two groups. One group received standard antibiotic therapy and placebo (control group). The other group received IgM Concentrate in addition to standard therapy. As already published, in the control group 28% of patients died within 28 days (28-day mortality). In the IgM Concentrate treatment group, the mortality was 22%.
Further analyses have been performed with the objective to identify the patient group that benefits most from IgM Concentrate therapy. More than 75% of patients showed a considerable elevation of inflammation markers before the start of treatment and these patients responded to IgM treatment to a greater extent. In these patients, a significant reduction in mortality was achieved and IgM Concentrate led to a relative reduction of mortality of more than 50%.
Coordinating investigator Prof Dr Tobias Welte (Head of Clinic for Pneumology, Hannover Medical School) stated, “sCAP is still a global problem because of the high mortality rates. The observed reduction of mortality is extraordinary. A successful phase III trial would be a breakthrough therapy option in this field.”
In general, tolerability of IgM Concentrate was good and the safety profile as expected in the treated severely ill population. The benefit / risk evaluation remains favourable.
Biotest is the only company producing a novel polyclonal IgM enriched immunoglobulin. Biotest is evaluating different applications of this unique product for further clinical development and a phase III trial.
About CIGMA (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 (sCAP). The purpose of this study was to determine whether the adjunctive therapy to standard antibiotic treatment of IgM Concentrate (BT086) is safe and effective in decreasing number of the days patients require endotracheal ventilation due to severe Community-Acquired Pneumonia. 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 (ICU) is up to 23-58 % depending on time and admission of the patient and has not improved much in recent years.
About IgM Concentrate
IgM Concentrate (IgM enriched immunoglobulin) is a new polyclonal IgM enriched immunoglobulin 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.
About Biotest
Biotest AG is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. In addition Biotest develops monoclonal antibodies in the indication cancer of plasma cells and systemic lupus erythematosus (SLE), which are produced by recombinant technologies. Biotest has more than 2,200 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
SOURCE: Biotest
Post Views: 222
-
Favourable new data of phase II trial with IgM Concentrate in patients with severe Community Acquired Pneumonia (sCAP) published at ISICEM Symposium
-
Strong data justifies phase III development
DREIEICH, Germany I March 16, 2016 I Biotest announces further results of a phase II trial with IgM Concentrate (IgM enriched immunoglobulin) in subgroups at the ISICEM Symposium in Brussels (International Symposium on Intensive Care and Emergency Medicine). The randomized, double-blind, placebo-controlled phase II trial (CIGMA trial) was performed in 160 hospitalised patients with severe community acquired pneumonia (sCAP).
Community acquired pneumonia (CAP) continues to be a leading cause of death worldwide. 10% of hospitalized patients with community acquired pneumonia develop a severe form (sCAP) that requires intensive medical care. Despite treatment with antibiotics patients with sCAP still have a high mortality of 23-58% due to severe infections. IgM Concentrate is investigated as an add-on therapy in addition to standard antibiotic therapy to reduce mortality. During hospitalisation the severity of infection is constantly monitored by inflammation markers.
In the phase II study patients were randomized to two groups. One group received standard antibiotic therapy and placebo (control group). The other group received IgM Concentrate in addition to standard therapy. As already published, in the control group 28% of patients died within 28 days (28-day mortality). In the IgM Concentrate treatment group, the mortality was 22%.
Further analyses have been performed with the objective to identify the patient group that benefits most from IgM Concentrate therapy. More than 75% of patients showed a considerable elevation of inflammation markers before the start of treatment and these patients responded to IgM treatment to a greater extent. In these patients, a significant reduction in mortality was achieved and IgM Concentrate led to a relative reduction of mortality of more than 50%.
Coordinating investigator Prof Dr Tobias Welte (Head of Clinic for Pneumology, Hannover Medical School) stated, “sCAP is still a global problem because of the high mortality rates. The observed reduction of mortality is extraordinary. A successful phase III trial would be a breakthrough therapy option in this field.”
In general, tolerability of IgM Concentrate was good and the safety profile as expected in the treated severely ill population. The benefit / risk evaluation remains favourable.
Biotest is the only company producing a novel polyclonal IgM enriched immunoglobulin. Biotest is evaluating different applications of this unique product for further clinical development and a phase III trial.
About CIGMA (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 (sCAP). The purpose of this study was to determine whether the adjunctive therapy to standard antibiotic treatment of IgM Concentrate (BT086) is safe and effective in decreasing number of the days patients require endotracheal ventilation due to severe Community-Acquired Pneumonia. 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 (ICU) is up to 23-58 % depending on time and admission of the patient and has not improved much in recent years.
About IgM Concentrate
IgM Concentrate (IgM enriched immunoglobulin) is a new polyclonal IgM enriched immunoglobulin 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.
About Biotest
Biotest AG is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. In addition Biotest develops monoclonal antibodies in the indication cancer of plasma cells and systemic lupus erythematosus (SLE), which are produced by recombinant technologies. Biotest has more than 2,200 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
SOURCE: Biotest
Post Views: 222
