Bio Products Laboratory (BPL) Enrolls First Subject in a Phase III Clinical Trial to Evaluate a New Subcutaneous Immunoglobulin Product for Patients with Primary Immunodeficiency
Date: September 1, 2015
Bio Products Laboratory, Limited (BPL) today announced enrollment of the first subject in the SCIG03 trial titled “A Phase III, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subgam ®VF in Primary Immunodeficiency Diseases” (clinicaltrials.gov identifier, NCT01884311.)” The clinical trial will enroll and treat 35 patients with primary immunodeficiency for up to 26 weeks in the U.S., forming the basis of a biologics license application for U.S. market authorization. The evaluation of the safety and pharmacokinetics of Subgam®VF (16% liquid immunoglobulin for the treatment of primary immunodeficiency) will be compared to previous studies during this clinical trial.
“Enrolling the first subject is an important step in our ongoing effort to bring high quality products into the U.S. market”, said Ken McNish, PhD, President of BPL US. “Patients with primary immunodeficiency need options for immunoglobulin replacement therapy, and we’re excited to investigate an additional option.”