ADMA Biologics, Inc. has announced they have completed recruitment for their Phase III clinical study of RI-002. RI-002 is a novel immune globulin for the treatment of patients who have Primary Immune Deficiency Diseases (PIDD). ADMA expects to have preliminary data available in the fourth quarter of 2014.
Dr. Richard L. Wasserman, Clinical Professor of Pediatrics, University of Texas Southwestern Medical School, and Director of Pediatric Allergy and Immunology, Medical City Children’s Hospital and lead Principal Investigator of ADMA’s Phase III trial, notes, “It is exciting to follow ADMA Biologics as they progress through their Phase III pivotal trial with a novel immune globulin product for the PIDD patient community. The availability of a high titer immune globulin product such as RI-002, indicated for use in the immune deficient population will be a welcome addition to the currently available therapies.”
RI-002, ADMA’s lead product candidate, is a plasma-derived polyclonal antibody. It is a naturally occurring intravenous immune globulin (IGIV) which has been isolated from human plasma that contains antibodies to Streptococcus pneumoniae, H. influenza type B, CMV, measles, tetanus etc. This human plasma also contained high levels of antibodies targeted to respiratory syncytial virus (RSV). ADMA is following an idea for the use of RI-002 as a therapy for patients diagnosed with primary immune deficiency diseases (PIDD).
The primary component of IGIV products is polyclonal antibodies which are large proteins made by B cells that mark an antigen, such as a bacterium or virus, for destruction. The RI-002 antibodies are expected to prevent infections in a patient that has a compromised immune system.
Primary immune deficiency diseases (PIDD) are a class of inherited genetic disorders that render an individual with a deficient or absent immune system. This can be due to a lack of proper antibodies or a failure of these antibodies to work. These patients are more likely to acquire infections and suffer complications from these infections. Apparently, there are more than 150 different forms of PIDD, according to the World Health Organization (WHO).
Patients who have PIDD typically receive monthly outpatient infusions of IGIV treatment. Without IGIV therapy, these patients would be susceptible to a number of infectious diseases. The prevalence of PIDD in the U.S. runs around one in 1,200 (250,000 individuals).
ADMA Biologics, Inc. is a biopharmaceutical company that develops, manufactures and intends to market late-stage specialty plasma-based biologics for treatment and prevention of specific infectious diseases. Their goal is to develop and commercialize plasma-derived, human immune globulins targeted to certain populations. These populations include immune-compromised patients who suffer from immune deficiency disease or who may be immune-compromised for medical reasons.