Green Cross Biotherapeutics Receives Health Canada Approval for Phase III Clinical Trials of IVIG 10%
MONTRÉAL (March 7, 2016) – Green Cross Biotherapeutics (GCBT), a Montréal-based biopharmaceutical company and member of the Green Cross family, is pleased to announce that Health Canada has approved its application to proceed with a multi-centre Phase III clinical trial for Immune Globulin Intravenous (Human) 10% GC5107 (IVIG 10%). 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,” a standard response stating that it has no objection to the proposed study. The Phase III trial will be conducted at leading clinical research sites in Canada and the United States. 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 Food and Drug Administration.
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.
About Primary Humoral Immunodeficiency (PID)
PID is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a failure of these antibodies to function properly. PID patients are more vulnerable to infections and more likely to suffer complications from these infections. According to the World Health Organization, there are over 150 different presentations of PID.
About Green Cross Biotherapeutics (GCBT)
Established in 2014, Green Cross Biotherapeutics (GCBT) is a Montréal-based biopharmaceutical company and member of the Green Cross family. GCBT is committed to producing high-quality, safe and effective products to save lives and improve the quality of life for people with rare and serious medical conditions.
As part of the $300 million expansion of its North American head office in Montréal, GCBT’s new state-of-the-art facility will produce plasma products such as IVIG and albumin, and serve as the cornerstone of the company’s global development strategy. With commercial production planned for 2019, GCBT will become Canada’s only IVIG manufacturer, marking a new chapter in the history of the Canadian biopharmaceutical industry.