Cx601 – USA

We have started a global Phase III trial intended to support a future Biologic License Application (BLA) in the United States.

The protocol for this trial, which is very similar to the European ADMIRE-CD study, has been agreed with the FDA.

We have selected Lonza as manufacturing partner for this study.
TiGenix holds full rights to Cx601 in the USA, estimated to represent roughly 50% of the global market.


GLOBAL SCIENTIFIC ADVISORY BOARD FOR ADMIRE-CD II TRIAL

Chairman: Pr. William J. Sandborn, MD Professor of Medicine and Adjunct Professor of Surgery Chief, Division of Gastroenterology Vice Chair for Clinical Operations, Department of Medicine Director, UCSD IBD Center University of California San Diego and UC San Diego Health System, La Jolla, USA.

Pr. Jean Frederic Colombel, MD Department of Gastroenterology Icahn School of Medicine at Mount Sinai, New York,USA

Pr. Brian Feagan, MD Professor of Medicine. Western University Robarts Clinical Trials, London, Ontario, Canada.

Pr. Damian García Olmo, MD Chief of Department of Surgery “Fundación Jimenez Diaz” University Hospital Universidad Autonoma de Madrid, Spain.

Pr. Stephen B. Hanauer, MD Professor of Medicine Northwestern University Feinberg School of Medicine Medical Director, Digestive Health Center Northwestern MedicineChicago, Illinois, USA.

Pr. Julián Panés, MD Head of Gastroenterology Department Hospital Clinic, Barcelona, Spain. Head of Inflammatory Bowel Disease IDIBAPS research team President of the European Crohn’s and Colitis Organization.

Pr. Bruce Sands, MD Chief of the Dr. Henry D. Janowitz Division of Gastroenterology Dr. Burrill B. Crohn Professor of Medicine Professor of Medicine Icahn School of Medicine Feinstein Clinical IBD Center at Mount Sinai, New York, USA.

Pr. David A. Schwartz, MD Director, Inflammatory Bowel Disease Center Professor of Medicine Vanderbilt University Medical Center, Nashville, Tennessee, .

Steven D Wexner, MD, PhD Director, Digestive Disease Center Chair, Department of Colorectal Surgery Cleveland Clinic Florida Affiliate Professor Florida Atlantic University College of Medicine Clinical Professor Florida International University College of Medicine Weston, Florida, USA.