Study no. 992 is the second pivotal phase III study in the clinical program for IgG Next Generation, a novel development of our polyvalent immunoglobulin G
Study design was agreed with European regulatory authorities and results will serve as basis for European approval
Clinical data from Primary Immunodeficiencies (PID) and ITP will automatically lead to the approval of additional indications in Europe
DREIEICH, Germany I January 25, 2017 I Biotest AG today announced that the first patient has been treated in study no. 992 – a phase III study investigating IgG Next Generation as immunomodulatory therapy in patients diagnosed with chronic primary immune thrombocytopenia, an autoimmune disease in which the immune system attacks and destroys the body’s own platelets, the cells that prevent bleeding in blood vessels and facilitate clotting.
The study is planned to include approximately 40 patients and will be conducted in a total of 18 study sites in Germany, Hungary, Spain, Bulgaria, Czech Republic and Serbia.
According to the European Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIG), there are two key studies required for the licensing of an IVIG in the European markets. Clinical data on efficacy and safety have to be generated in PID and primary immune thrombocytopenia (ITP) – to provide evidence as replacement therapy and to prove the immunomodulatory effect of immunoglobulines, respectively.
Following approval, IgG Next Generation can be marketed additionally in the following established indications of IVIG:
•Replacement therapy in secondary immunodeficiency disease e.g.
o chronic lymphocytic leukaemia,
o multiple myeloma and
o after allogeneic haematopoietic stem cell transplantation
•Immunomodulatory therapy in
o Guillain Barré Syndrome (GBS) and
o Kawasaki disease
IgG Next Generation is manufactured using a brand new production process and will serve as the master product or the new Biotest Next Level manufacturing facility currently under construction. This new manufacturing facility, which uses state of the art technologies, represents Biotest’s latest commitment to the global immunoglobulin markets.
In 2014 the market volume of immunoglobulins for the indication PID in US and EU amounted to approximately € 1.5 billion. The additional market volume of ITP and the supplementary indications in Europe amounted to approximately € 0.8 billion.
About study no. 992
Study no. 992 is a phase III, open label, prospective, multicenter trial investigating the clinical efficacy and safety of IgG Next Generation as immunomodulatory therapy in adult patients diagnosed with chronic primary immune thrombocytopenia (ITP) at high risk of bleeding or before surgery to correct the platelet count.
Subjects will be randomized in a 1:1 ratio to receive either 1 g/kg bodyweight per day for 2 consecutive days or 0.4 g/kg bodyweight per day on 5 consecutive days. The primary objective of this study is to determine the percentage of patients who achieve response. A response is defined as a platelet count of ≥30×109/L and at least a 2-fold increase of the baseline count and the absence of bleeding.
More information about the study design can be found at www.clinicaltrialsregister.eu (EudraCT Number: 2015-003653-17)
About Primary Immune Thrombocytopenia (ITP)
Primary immune thrombocytopenia – also formerly known as idiopathic thrombocytopenic purpura or Immune thrombocytopenic purpura is an autoimmune-mediated condition, in which autoantibodies with specificity for one or more platelet membrane glycoproteins (GPs), binds to circulating platelet membranes. The coating of platelets with autoantibodies renders them susceptible for elimination from the blood.
Because patients suffering from ITP have a low platelet count, they may bruise easily and experience bleeding that is hard to stop. ITP is a rare blood disorder that affects about five to nine in 100,000 adults each year.
About Biotest
Biotest 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 specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins derived from human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 2,500 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
SOURCE: Biotest
Post Views: 163
Study no. 992 is the second pivotal phase III study in the clinical program for IgG Next Generation, a novel development of our polyvalent immunoglobulin G
Study design was agreed with European regulatory authorities and results will serve as basis for European approval
Clinical data from Primary Immunodeficiencies (PID) and ITP will automatically lead to the approval of additional indications in Europe
DREIEICH, Germany I January 25, 2017 I Biotest AG today announced that the first patient has been treated in study no. 992 – a phase III study investigating IgG Next Generation as immunomodulatory therapy in patients diagnosed with chronic primary immune thrombocytopenia, an autoimmune disease in which the immune system attacks and destroys the body’s own platelets, the cells that prevent bleeding in blood vessels and facilitate clotting.
The study is planned to include approximately 40 patients and will be conducted in a total of 18 study sites in Germany, Hungary, Spain, Bulgaria, Czech Republic and Serbia.
According to the European Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIG), there are two key studies required for the licensing of an IVIG in the European markets. Clinical data on efficacy and safety have to be generated in PID and primary immune thrombocytopenia (ITP) – to provide evidence as replacement therapy and to prove the immunomodulatory effect of immunoglobulines, respectively.
Following approval, IgG Next Generation can be marketed additionally in the following established indications of IVIG:
•Replacement therapy in secondary immunodeficiency disease e.g.
o chronic lymphocytic leukaemia,
o multiple myeloma and
o after allogeneic haematopoietic stem cell transplantation
•Immunomodulatory therapy in
o Guillain Barré Syndrome (GBS) and
o Kawasaki disease
IgG Next Generation is manufactured using a brand new production process and will serve as the master product or the new Biotest Next Level manufacturing facility currently under construction. This new manufacturing facility, which uses state of the art technologies, represents Biotest’s latest commitment to the global immunoglobulin markets.
In 2014 the market volume of immunoglobulins for the indication PID in US and EU amounted to approximately € 1.5 billion. The additional market volume of ITP and the supplementary indications in Europe amounted to approximately € 0.8 billion.
About study no. 992
Study no. 992 is a phase III, open label, prospective, multicenter trial investigating the clinical efficacy and safety of IgG Next Generation as immunomodulatory therapy in adult patients diagnosed with chronic primary immune thrombocytopenia (ITP) at high risk of bleeding or before surgery to correct the platelet count.
Subjects will be randomized in a 1:1 ratio to receive either 1 g/kg bodyweight per day for 2 consecutive days or 0.4 g/kg bodyweight per day on 5 consecutive days. The primary objective of this study is to determine the percentage of patients who achieve response. A response is defined as a platelet count of ≥30×109/L and at least a 2-fold increase of the baseline count and the absence of bleeding.
More information about the study design can be found at www.clinicaltrialsregister.eu (EudraCT Number: 2015-003653-17)
About Primary Immune Thrombocytopenia (ITP)
Primary immune thrombocytopenia – also formerly known as idiopathic thrombocytopenic purpura or Immune thrombocytopenic purpura is an autoimmune-mediated condition, in which autoantibodies with specificity for one or more platelet membrane glycoproteins (GPs), binds to circulating platelet membranes. The coating of platelets with autoantibodies renders them susceptible for elimination from the blood.
Because patients suffering from ITP have a low platelet count, they may bruise easily and experience bleeding that is hard to stop. ITP is a rare blood disorder that affects about five to nine in 100,000 adults each year.
About Biotest
Biotest 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 specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins derived from human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 2,500 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
SOURCE: Biotest
Post Views: 163
