Digna in press

May 15, 2009 | media: Press Release

Cardiotrophin-1 showed to improve survival in a rabbit model of fulminant hepatic failure (FHF) of viral origin.

Biotecnol and Digna Biotech have announced today that therapy with cardiotrophin I (CT1) showed to improve survival rates in a model of fulminant viral hepatitis in rabbits. Such results are highly encouraging for the consortium as it suggests the possibility for expanding its on-going CT1 programme to other applications in the field of liver diseases, such as human fulminant hepatic failure (FHF) of viral origin. This condition constitutes a formidable medical challenge since it lacks effective therapy other than organ transplantation.

Researchers from the University of Navarra (CIMA) and University of Leon (CIBERehd, Institute of Biomedicine and Department of Animal Health) presented recently their results at the Congress of the European Association for the Study of Liver (EASL 2009, Copenhagen). Nine week-old rabbits (n=24) were injected intramuscularly with 2x104 hemagglutination units of RHDV isolate Ast/89. Animals were divided into three groups: a) one group received CT-1 (400 microg/kg body weight) at 12h and 18h post-infection (pi); b) one group received the same dose of CT-1 at 12h, 18h and 24h pi, and c) a control group received saline. At 36h post infection survival of control rabbits was reduced to 55%, while all CT-1 treated animals remained alive. At 60h post-infection survival rates were 18% in control animals and 80% in CT-1 treated ones. Seven days following RHDV administration, all control animal had died, while 33% of those treated with two doses of CT-1 and 80% of those treated with three doses of CT-1 survived. During the first 48h after infection serum transaminases were lower in animals that received CT-1 than in controls. They could conclud that therapy with CT-1was efficient in increasing survival in a model of fulminant viral hepatitis in rabbits.

“The mechanisms underlying this beneficial effect are under investigation. It seems likely that combination of the cytoprotective properties of CT-1 together with stimulation of liver regeneration might explain the favorable resolution of the disease in most CT-1 treated animals” said Professor Jesus Prieto from CIMA, who directed the study.

“CT1 is soon due to enter clinical studies aiming at improving hepatic function and decrease liver damage after major liver resection and in a second trial aiming at improving hepatic function and decrease postoperative complications after liver transplantation. We are studying other potential applications for such a promising drug, which we hope we will be a first-in-class product to address the treatment of various liver and metabolic diseases”.

“If such new application is successful, it would be a great opportunity for building further value into the consortium, in addition to our achievements so far” said Pedro de Noronha Pissarra, Chief Executive Officer of Biotecnol. “The consortium will continue working in order to bring the product to Phase II clinical trials. Digna Biotech and Biotecnol, together with these academic centre of excellence have successfully managed to set-up a first class example of cutting edge translational research, with a clear aim of taking valuable products right from the bench to the clinic, he added”.

About Cardiotrophin-1 and the Consortium

Cardiotrophin-1 (CT-1) is a member of the interleukin (IL-6) family of cytokines, which includes other cytokines such as IL-6, leukaemia inhibitory factor (LIF), ciliary neurotrophic factor (CNTF), oncostatin M, IL-11, IL-27, cardiotrophin-like-cytokine (CLC) and neuropoietin. All cytokines in this family signal through receptor complexes that includes the receptor subunit glycoprotein-130 (gp-130). Previous studies have indicated that this protein is able to stimulate hepatic regeneration and to protect liver parenchyma in diverse animal models of hepatic damage including ConA hepatitis and ischemia/repersfusion liver injury during transplants. Biotecnol and Digna Biotech (Spain ) have established a co-development agreement for developing recombinant human CT-1 as a first in class drug to treat liver diseases including the reduction of ischemic and/or reperfusion injury in the liver or kidney transplantations, and liver regeneration following hepatectomy/resection. CT-1 has already been granted Orphan Drug Status by the FDA (June 2008), and by the EMEA (Orphan Designation Number EU/3/06/396) for prevention of ischemia/reperfusion injury associated with solid organ transplantation.

About Biotecnol

Biotecnol is a biotechnology company developing biopharmaceutical products, and has a special focus on the development of novel antibody-based therapeutics to treat life-threatening diseases such as cancer. Biotecnol has a proprietary antibody format, which allows to develop multi-specific antibodies against various cancer targets. These formats are called Tribodies™. Biotecnol is committed in building value by developing a diverse pipeline of antibody products to address unmet healthcare needs. Biotecnol has a presence in the USA and carries its product development activities via its fully owned subsidiary Biotecnol Pharmaceuticals Inc.

Through its facilities in Portugal, Biotecnol leverages its business income by establishing in-house partner-led or collaborative programmes, which provide Biotecnol a strong client-based activity and an established track record. Biotecnol uses its proprietary expression technology, cell line development capabilities, upstream and downstream processing, analytics and QC experience for delivering therapeutic recombinant protein product and processes to support all stages of product development through early research and preclinical activities to GMP/GLP compliant processes for biomanufacturing of clinical and ultimately commercial products.

About Digna Biotech

Digna Biotech is a biotechnology company located in Navarra, Spain, emerging from a collaboration agreement between the University of Navarra and a group of investors representing some of the most important companies in Spain. Digna Biotech’s mission is the development of the intellectual property generated by CIMA at the preclinical, clinical and commercial level. CIMA, with more than 370 investigators and technicians, performs research in gene therapy and hepatology, oncology, neurology and cardiovascular areas, taking advantage of the collaborations with the University Clinic of Navarra and the Schools of Medicine, Pharmacy and Biological Sciences from the University of Navarra. The goal of CIMA is to obtain results that can be applied to patients.

<< Back