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Breaking News, Trials & Filings

ADMA Bio Completes Ph III Enrollment

Expects PIDD trial data in 4Q14

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

ADMA Biologics has completed 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 4Q14.

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 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.

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