Published on March 7, 2013 at 11:39 PM
ADMA Biologics, Inc. (ADMA), a specialty immune globulin company that develops, manufactures and intends to market plasma-based biologics for the treatment and prevention of certain infectious diseases, announced that the first patient enrolled in the pivotal Phase III clinical study of its RI-002 has been dosed. This study is designed to evaluate the efficacy and safety of RI-002 as a novel immune globulin for the treatment of patients who suffer from Primary Immune Deficiency Diseases (PIDD).
The trial is being conducted in accordance with the U.S. Food and Drug Administration (FDA) published guidance for the industry (June 2008) and intends to evaluate RI-002 in an aggregate of between 60 and 70 patients diagnosed with PIDD, for a 12-month treatment period followed by up to 90 days of safety monitoring and follow-up. ADMA anticipates enrolling patients at investigative centers across the United States.
"We are excited to be working with leaders in the PIDD community to evaluate the safety and efficacy of RI-002," said Adam S. Grossman, President and Chief Executive Officer of ADMA. "RI-002 will offer PIDD patients additional treatment options, while providing clinicians who see all types of immune deficient patients with greater flexibility."
"It is encouraging to see a company like ADMA Biologics championing a specialty immune globulin product for the PIDD patient community. Having access to a specialty, high titer immune globulin product such as RI-002, indicated for use in the PIDD population would be a welcome addition to currently available therapies," said Dr. Richard L. Wasserman, Clinical Professor of Pediatrics, University of Texas Southwestern Medical School and Lead Principal Investigator of ADMA's Phase III trial.
Source: ADMA Biologics, Inc.