Digna Biotech and Biotecnol (The Consortium) announced today that the Spanish Regulatory Medicine Agency has authorized the start of a Phase I Clinical Trial in healthy volunteers for Cardiotrophin-I (CT-I). The study will be conducted in Hospital Universitario Puerta de Hierro de Majadahonda in Madrid and Clinica Universidad de Navarra in Pamplona, and will include 33 healthy volunteers.
Researchers from the Center for Applied Medical Research (CIMA) discovered that CT-I is able to stimulate hepatic regeneration after partial hepatectomy, as well as to defend the liver against warm ischemia reperfusion injury. It also protects hepatocytes from death during an acute liver failure situation. Based on these data, CIMA obtained the intellectual property of CT-I for its use in hepatic diseases. The pre-clinical development of CT-I has been possible thanks to the financial support of ClaveSuan, the Center for the Industrial and Technological Development (CDTI) and the Government of Navarra.
The Consortium entered into an Exclusive Option and Licensing agreement with Genentech, Inc (a fully owned subsidiary of the Roche group) inSeptember 2009.
CT-I is a member of the interleukin (IL) 6 family of cytokines. Our studies have demonstrated that the administration of recombinant CT-I produces a clear hepatoprotective effect in several animal models of liver failure and induces liver regeneration in partial hepatectomy models.
CT-I has been already granted Orphan Drug Status (EU/3/06/396) by the European Medicines Agency (EMA) and the US Food & Drug Administration (FDA) for the prevention of ischemia/reperfusion injury associated with solid organ transplantation. It has also obtained FDA Orphan Status for liver transplantation.
About CIMA and Digna Biotech
CIMA (University of Navarra) brings pure research closer to its clinical application, carrying out high-quality scientific work in the service of humankind, combating diseases that cause great suffering and for which no cure has yet been discovered.
Digna Biotech is a biotechnological company focused on the development of products originated from CIMA. Currently, Digna’s portfolio includes another two products under clinical development such as P144 and Interferon alpha-5.
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.
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.
More informations: BIOTECNOL