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news.ADMA Biologics has commenced a pivotal Phase III clinical study with the first patient being dosage with its RI-002, designed to treat patients with primary immune deficiency diseases (PIDD).
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RI-002, a specialty plasma-derived, polyclonal intravenous immune globulin, contains 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.
The study will recruit 60 and 70 patients from investigative US centers to demonstrate the safety and efficacy of RI-002 in patients for a 12-month treatment period, followed by up to 90 days of safety monitoring and follow-up.
ADMA Biologics president and chief executive officer Adam Grossman said RI-002 will offer PIDD patients additional treatment options and provide clinicians who see all types of immune deficient patients with greater flexibility.
"We are excited to be working with leaders in the PIDD community to evaluate the safety and efficacy of RI-002," Grossman added.
The company said the study is being conducted in accordance with the US Food and Drug Administration (FDA) published guidance for the industry (June 2008).