ELSTREE, England & DURHAM, N.C.--(BUSINESS WIRE)--Bio Products Laboratory, Limited (BPL), a leading manufacturer of plasma-derived protein therapies, today announced that the first subject has enrolled in SCIG03, a clinical trial evaluating the safety and pharmacokinetics of Subgam®VF, 16% liquid immunoglobulin for the treatment of primary immunodeficiency. The 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), will take place in the U.S. and will form the basis of a biologics license application for U.S. marketing authorization.
The trial will enroll 35 patients with primary immunodeficiency and treat them for up to 26 weeks. The pharmacokinetics of Subgam®VF will be assessed and will be compared to previous studies. Subgam-VF is a 16% immunoglobulin product made from human plasma specifically for subcutaneous use. The product is undergoing testing in the U.S. and has not been evaluated by the U.S. Food and Drug Administration.
“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.”
About Bio Products Laboratory, Ltd.
Bio Products laboratory, Limited (BPL) is a leading manufacturer of plasma-derived protein therapies with global headquarters in Elstree, England, US headquarters in Durham, NC, and a presence in more than 45 countries worldwide. The company has over 60 years of experience developing and manufacturing plasma-derived therapies since being established as part of the Lister Institute in 1950, and currently markets Gammaplex in the US and a wide range of products outside the US, including coagulation factors, human immunoglobulins, and albumin. BPL is committed to continued investment in research and development to maintain its key position as a reliable supplier of high quality products to patients and healthcare providers worldwide.