RAMSEY, N.J.--(BUSINESS WIRE)--ADMA Biologics, Inc. (OTCQB:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, today announced the completion of enrollment for its Phase III clinical study of RI-002. This study is designed to evaluate the efficacy and safety of RI-002 as a novel immune globulin for the treatment of patients who are affected by Primary Immune Deficiency Diseases (PIDD). ADMA expects to have preliminary Phase III data in the fourth quarter of 2014.
“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,” said Dr. Richard L. Wasserman, Clinical Professor of Pediatrics, University of Texas Southwestern Medical School, Director of Pediatric Allergy and Immunology, Medical City Children's Hospital and lead Principal Investigator of ADMA’s Phase III trial. “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.”
“We are very pleased to announce that recruitment for our Phase III clinical study has been completed,” stated, Adam Grossman, President and Chief Executive Officer of ADMA. “This is a significant milestone for our lead product candidate and puts the company in a good position to report preliminary Phase III data during the fourth quarter of 2014. We are sincerely appreciative of our participating investigators who are leaders in the PIDD community for their enthusiasm and efforts as they continue to move our study forward.”
About ADMA’s lead product candidate RI-002
ADMA’s lead product candidate, RI-002 is a specialty plasma-derived, polyclonal, Intravenous Immune Globulin, or IGIV, derived from human plasma containing naturally occurring polyclonal antibodies (eg. streptococcus pneumoniae, H. influenza type B, CMV, measles, tetanus etc.) as well as high levels of antibodies targeted to respiratory syncytial virus, or RSV. ADMA is pursuing an indication for the use of this specialty IGIV product for treatment of patients diagnosed with primary immune deficiency diseases, or PIDD. Polyclonal antibodies are the primary component of IGIV products. Polyclonal antibodies are proteins produced by B-cells that are used by the body’s immune system to neutralize microbes such as bacteria and viruses. The polyclonal antibodies that are present in RI-002 are expected to prevent infections in immune-compromised patients. The product is currently being evaluated in a Phase III trial in the United States.
About Primary Immune Deficiency Disease (PIDD)
PIDD is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a failure of these antibodies to function properly. PIDD patients are more vulnerable to infections and more likely to suffer complications from these infections. According to the World Health Organization, there are over 150 different presentations of PIDD. As patients suffering from PIDD lack a properly functioning immune system, they typically receive monthly, outpatient infusions of IGIV therapy. Without this exogenous antibody immune support, these patients would be susceptible to a wide variety of infectious diseases. PIDD has an estimated prevalence of 1:1,200 in the United States, or approximately 250,000 people.
About ADMA Biologics, Inc.
ADMA is a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases. ADMA’s mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases. The target patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disease or who may be immune-compromised for medical reasons. ADMA also operates ADMA Bio Centers, an FDA-licensed and GHA-certified source plasma collection facility located in Norcross, Georgia, which provides ADMA with a portion of its blood plasma for the manufacture of RI-002. For more information please visit the Company’s website at www.admabiologics.com.
Cautionary Statement Regarding Forward-Looking Information
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