Leuven (BELGIUM) - 19th November 2015 - TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, announced today that it has completed enrolment of its Phase II study in acute myocardial Infarction (CAREMI study).
CAREMI is a two phase study consisting of an open-label dose-escalation phase I completed in June 2015, and a randomised, double-blind, placebo-controlled phase II, aiming at evaluating the safety and efficacy of intracoronary infusion of AlloCSC-01, a suspension of allogeneic human cardiac stem cells (CSCs), in patients that have suffered an acute myocardial infarction (AMI). Enrolment of this second phase has been completed with the treatment of the last of the planned 49 patients. The trial has now entered in its 12 month follow-up period.
“We are very satisfied with the timely completion of the enrolment of the randomised phase of the trial. We see this as evidence of the close collaboration maintained with our clinical partners in the cardiology space”, said Dr. Marie Paule Richard, Chief Medical Officer at TiGenix, “This achievement will enable us to perform a 6-month interim blinded exploratory analysis and obtain preliminary efficacy data early in the second half of 2016, with final results in the first half of 2017.”
We believe AlloCSC-01 may become a new approach to prevent cardiac remodelling and the onset of Chronic Heart Failure (CHF) after AMI. In the United States and Europe, approximately 1.5 million AMIs are treated annually. Current AMI management therapeutic options including Percutaneous Transluminal Coronary Angioplasty (PTCA), combined with stent implantation, are in most cases successful in re-establishing the perfusion of the ischemic myocardium and have helped to reduce the immediate mortality after infarct. However, these treatments are not able to recover the injured tissue. In fact all currently approved therapeutic approaches are palliative and designed to preserve the function of the surviving myocardium.
The CAREMI trial will help to establish AlloCSC-01 as a potential means to reduce the damage caused by the infarct and improve the prognosis of AMI patients in this very large indication. Eight clinical centers of reference in cardiology have participated in the CAREMI trial led by Prof. Fernández-Avilés of Hospital Gregorio Marañón in Madrid, Spain, and Prof. Stefan Janssens of KU Leuven, Belgium, as principal investigators. The CAREMI trial has been supported by the Seventh Framework Programme of the European Commission, a transnational research funding initiative, as part of the CARE-MI project (Grant Number 242038).
