Cx611 is an intravenous injection of allogeneic expanded adipose-derived stem cells (eASC’s) in development.

Severe sepsis

Sepsis is a potentially life-threatening complication of infection. Sepsis occurs when inflammatory molecules released into the bloodstream to fight the infection trigger systemic inflammation. This inflammation can trigger a cascade of detrimental changes that damage multiple organ systems, causing them to fail. If sepsis progresses to septic shock, blood pressure drops dramatically, which may lead to death. Patients with severe sepsis require close monitoring and treatment in a hospital intensive care unit. Drug therapy is likely to include broad-spectrum antibiotics, corticosteroids, vasopressor drugs to increase blood pressure, as well as oxygen and large amounts of intravenous fluids. Supportive therapy may be needed to stabilise breathing and heart function and to replace kidney function. Patients with severe sepsis have a low survival rate so there is a critical need to improve the effectiveness of current therapy. Only a small number of new molecular entities are currently in development for severe sepsis.

In animal models, eASCs have been shown both to decrease pro-inflammatory mediators and to increase anti-inflammatory mediators, and to have anti-microbial effects. As a result of this mechanism of action, Cx611 has demonstrated efficacy in significantly reducing mortality in two animal models of sepsis. TiGenix therefore believes that Cx611 has a potentially important role when combined with current standards of care in patients with severe sepsis.

The company has produced a development plan for Cx611 in this indication with an Advisory Board of Professor Pierre-François Laterre (Professor of Medicine and Head of Intensive Care, Saint Luc University Hospital, Brussels, Belgium), Dr. Bruno François (Service de Réanimation Polyvalente, Centre Hospitalier Universitaire, Limoges, France), Professor Sébastien Gibot (Service de Réanimation Médicale, Centre Hospitalier Universitaire, Nancy, France) and Professor Tom van der Poll (Department of Internal Medicine, Academic Medical Center, University of Amsterdam, The Netherlands).

Cx611 is an intravenously-administered product of allogeneic expanded adipose-derived stem cells (eASCs). In May 2015, TiGenix completed a Phase I sepsis challenge trial demonstrating the favorable safety and tolerability profile of Cx611. Based on the results of this study, TiGenix has designed a Phase Ib/IIa trial in severe sepsis secondary to severe community-acquired pneumonia (sCAP) which is expected to enrol 180 patients across Europe (the SEPCELL project). The SEPCELL Phase Ib/IIa study in severe sepsis is expected to start in the second half of 2016. SEPCELL has been awarded a EUR 5.4M grant by the European Union under the Horizon 2020 Research and Innovation Programme under Grant Agreement 681031.

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