Nabi Biopharmaceuticals has initiated its phase II "proof-of-concept" clinical trial for Civacir. Civacir, the company's plasma-derived, polyclonal antibody product candidate, when approved, would be the first therapy for the prevention of the recurrence of hepatitis C-related liver disease in hepatitis C virus (HCV) positive liver transplant recipients, or in patients who received an HCV-positive liver.
Currently, there are no marketed therapies specifically indicated for prevention of re-infection post-liver transplant in HCV-positive patients. The trial marked another critical milestone being met by the company.
Nabi Biopharmaceuticals is co-developing Civacir with Kedrion S.p.A.. Kedrion is fully funding the costs of the clinical trials and is also funding some of the costs of manufacturing Civacir for use in the trial. The two companies will pursue a common strategy to develop and commercialise Civacir in Europe and the US, with Kedrion being Nabi Biopharmaceuticals' exclusive licensee to commercialise Civacir in Europe. In addition to assuming the majority of the funding for the clinical trials and clinical materials in Europe and the US, Kedrion will pay milestone and royalty payments to Nabi Biopharmaceuticals.
Thomas H McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, "Civacir is uniquely positioned to fill a critical gap in the care of liver transplant patients by preventing re-infection with hepatitis C during a period after surgery when other therapies cannot be used. If we are successful, this product will become a very important part of our global transplant franchise and product portfolio. Certainly, initiating this phase II 'proof-of-concept' trial is an important milestone for our partner, Kedrion and us. But this trial also represents an important milestone for advancing clinical knowledge in an area of significant, unmet medical need.
We are pleased to be partnering with Kedrion, who is contributing important knowledge and resources to this programme. Through our strategic partnership, we expect to conduct this and future clinical trials for Civacir in a way that is faster and at the same time much less costly for Nabi Biopharmaceuticals."