Cardiotrophin I to Start Phase I Clinical Studies

By Digna Biotech, PRNE
Tuesday, March 15, 2011

MADRID and OEIRAS, Portugal, March 16, 2011 - 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 ClĂ­nica 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

The Consortium entered into an Exclusive Option and Licensing agreement
with Genentech, Inc (a fully owned subsidiary of the Roche group) in
September 2009.

About Cardiotrophin-I

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

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.

About Biotecnol

Biotecnol is a developing biotechnology company with a special focus on
novel antibody-based therapeutics to treat life-threatening diseases such as
cancer. It has a proprietary antibody format called Tribodies(TM).

Further information can be found at; and

Digna Biotech Contact: Beatriz Gil-Alberdi, +34(0)913593154, healthco at; Biotecnol Contact: press at

will not be displayed