Montreal, QC – Green Cross Biotherapeutics (GCBT), a Montréal-based biopharmaceutical company and subsidiary of Green Cross , reports that Health Canada has approved its application to proceed with a multi-centre Phase 3 clinical trial for its Immune Globulin Intravenous (Human) 10% GC5107 (IVIG 10%) product. IVIG is intended for the treatment of individuals with Primary Humoral Immunodeficiency (PID), a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system.
“GCBT is excited to take this next step towards its objective of becoming Canada’s only IVIG manufacturer,” said Young Ho Kim, CEO of Green Cross Biotherapeutics. “Green Cross has decades of experience bringing IVIG and other biopharmaceuticals to other countries, and our Montréal team is looking forward to starting work on the main study objectives of demonstrating safety and efficacy here in Canada.”
Health Canada reviewed GCBT’s Clinical Trial Application and approved it by issuing a No Objection Letter. The Phase 3 trial will be conducted at clinical research sites in Canada and the US. An Investigational New Drug submission to the US FDA will soon follow and regulatory submissions are planned for Q1 2018 to Health Canada and shortly after to the US FDA.
GCBT’s new, state-of-the art Montréal facility will also produce albumin, a blood-volumizing agent. In addition, the biopharmaceutical company is exploring opportunities to manufacture other plasma protein products for the Canadian and international markets.