First patient treated in global clinical phase III study of IgG Next Generation in the indication Primary Immunodeficiency Disease (PID)
- Category: Antibodies
- Published on Tuesday, 08 November 2016 08:47
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- Study no. 991 marks the first phase III study in the worldwide clinical development program for IgG Next Generation, a novel development of our polyvalent immunoglobulin G
- Study design was agreed with US and European regulatory authorities and approved by all participating countries
- Results will serve as basis for worldwide approval
DREIEICH, Germany I November 8, 2016 I Biotest AG today announced that the first patient has been treated in study no. 991 - a phase III study investigating IgG Next Generation as replacement therapy in patients diagnosed with primary immunodeficiency disease (PID), a group of disorders in which a part of the body's immune system is missing or does not function properly.
To establish the basis for worldwide marketing approval the study design was discussed in detail with two major health authorities, the German Paul-Ehrlich Institute (PEI), and in the United States the American Food and Drug Administration (FDA).
The study is planned to include approximately 60 patients and will be conducted in a total of 24 study sites in the United States, Germany, United Kingdom, Hungary, Spain and Russia.
IgG Next Generation is being manufactured using a brand new production process and will be the master product for the Biotest Next Level manufacturing facility currently under construction. This modern 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 solely for the indication PID in US and EU amounted to approximately € 1.5 billion.
About study no. 991
Study no. 991 is a phase III, open label, prospective, multicenter trial and will investigate the clinical efficacy, safety, and pharmacokinetic properties of IgG Next Generation as replacement therapy in pediatric and adult patients diagnosed with primary immunodeficiency disease (PID). Patients previously receiving IVIG (immunoglobulins for intravenous use) treatment are switched to infusions with IgG Next Generation and treated for 12 months. The initial dose and dosage intervals will be kept consistent with the patient’s prestudy IVIG treatment.
The primary objective of this study is to demonstrate that IgG Next Generation provides effective protection against infection by supplementing and maintaining a normal level of immunoglobulin in the patients' body. According to established guidelines on the clinical investigation of immunoglobulin, the rate of acute serious bacterial infections per patient year should be less than one to provide substantial evidence of efficacy. More information about the study design can be found at www.clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT02810444)
About Primary Immunodeficiency
Primary immunodeficiencies (PI) – also called primary immune disorders or primary immunodeficiency disorders (PID) - are a group of currently 200 identified hereditary and genetic disorders, in which some of the body's immune defenses are absent or dysfunctional. It is estimated that worldwide at least 10 million children and adults may be affected by PI.
One of the most common signs of PI is an increased susceptibility to a wide range of germs like bacteria, viruses and fungi that can cause infections. Infections in patients diagnosed with PI are more frequent, longer lasting or harder to treat than are the infections of someone with a normal immune system. Patients with PID typically require life-long immunoglobulin replacement therapy to prevent recurrent infections.
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 based on 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 2,400 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.