Its lead program, AlloCSC-01, is an allogeneic cardiac stem cell product currently in a phase II trial in acute myocardial infarction (AMI), with interim data expected in the second half of 2016. The product also is in preclinical development for another cardiac disease. This acquisition expands TiGenix pipeline into cardiology indications and is expected to be closed July 31, 2015, subject to certain conditions precedent.
TiGenix acquires Coretherapix for an upfront payment of about $1.32 million in cash and roughly $6 million in new TiGenix shares. Additionally, Genetrix may receive up to $16.5 million in new TiGenix shares depending on the results of the ongoing clinical trial of Coretherapix. Based on and subject to future sales milestones, Genetrix may also receive up to $269 million plus certain percentages of the direct net sales of the first product, or certain percentages of any third party royalties and sales milestones for the first product.
Genetrix will receive a $27.4 million milestone payment per additional product reaching the market. The new shares to be issued on closing of the transaction will be subject to lock-up undertakings for up to 12 months, part of which will be gradually released from the lock-up over the 12-month period.
“The acquisition of this technology of allogeneic cardiac stem cells enhances our existing platform and builds on our extensive knowledge and experience in cell therapy development,” said Eduardo Bravo, chief operating officer of TiGenix. “Tactically, it broadens our current pipeline with another phase II program, which targets a very significant commercial opportunity. Strategically, it allows us to enter completely new markets with a platform of cardiac stem cells which could be developed in several attractive cardiology indications.
“We have Cx601 delivering phase III results in the treatment of perianal fistulas in Crohn’s disease patients, later this quarter and preparing for a second phase III in the U.S., and we have Cx611 ready to enter into phase II in severe sepsis and early rheumatoid arthritis around the end of the year.”
The ongoing, randomized, placebo-controlled, multicenter, phase II study in AMI is being conducted in nine hospitals in Belgium and Spain. After a successful open-label dose escalation phase of six patients, the clinical trial is aiming at recruiting 49 additional patients who will be randomized 2:1 to receive either AlloCSC-01 or placebo by intracoronary injection five to eight days after the myocardial infarction.
The primary endpoint is all-cause mortality and MACE (Major Adverse Cardiac Events) at 30 days. Secondary endpoints include efficacy MRI parameters (evolution of infarct size and evolution of biomechanical parameters), clinical parameters (including the six minute walking test and the New York Heart Association scale) and all-cause mortality and MACE, all measured at six and 12 months. More than 60% of patients already have been recruited and the final results are expected in the first half of 2017. A six-month interim analysis is expected to provide data in the second half of 2016.
AMI remains a significant unmet medical need with an estimated incidence of 1.9 million new patients each year in the U.S. and E.U. An effective management of AMI patients is considered to be crucial in reducing the continually increasing number of patients suffering from heart failure, currently around 26 million people worldwide. In the U.S. alone, the economic burden from HF disease is expected to increase sharply from $39 billion to $70 billion in 2030.