Date: 2015-11-02
Type of information: Grant
Company: SEPCELL consortium [Tigenix (Belgium) CHU de Limoges (France) Cliniques Universitaires Saint-Luc (Belgium) Hospital Clínico San Carlos of the Servicio Madrileño de Salud in Madrid (Spain) Academic Medical Center of the University of Amsterdam (The Netherlands)]
Investors: European Commission’s Horizon 2020 programme
Amount: €5.4 million
Funding type: grant
Planned used: Severe sepsis is a sepsis complicated by acute organ dysfunction. Lung infections, in particular community-acquire pneumonia (CAP), are the leading cause of severe sepsis. The pathophysiologic mechanism of CAP-mediated severe sepsis is the complete dysregulation of the patient´s immune system. In an initial phase, the systemic hyperactivation of the host immune response against infection leads to high levels of inflammatory mediators, systemic vasodilatation, micro-vascular thrombosis and organ failure. In a second phase, the exaggerated activation of the immune response leads to a state of ‘immunoparalysis’, which is characterized by the occurrence of secondary, opportunistic infections. The current standard of care (infection removal and control, functional support) does not improve the high mortality and, thus, CAP-mediated severe sepsis represents a major unmet medical need with a huge social burden. Therefore, treatments with the potential to modulate both the initial exacerbated immunoactivation and the subsequent immunosuppression are needed. Mesenchymal stem cells (MSCs), including adipose mesenchymal stem cells (ASCs), are known for their broad range of immunomodulatory properties, targeting multiple pro- and anti-inflammatory pathways, and possess antimicrobial capacities (releasing bactericidal peptides and promoting the phagocytosis by immune cells). Indeed, therapeutic benefit of MSC treatment in in vivo experimental models of sepsis has been extensively reported. The SEPCELL consortium believes that cell therapy with allogeneic ASCs may be an innovative therapeutic approach in order to re-establish the normal immune homeostasis of CAP-mediated SS patients, reducing organ injury and restoring organ functionality. A Phase Ib/IIa randomised, double-blind, parallel group, placebo-controlled, multicentre study will be performed to evaluate the safety and efficacy of Cx611 for the treatment of adult patients with severe sepsis secondary to sCAP and admitted to the intensive care unit. Cx611 is an intravenously-administered suspension of allogeneic expanded adipose-derived stem cells (eASCs). In May 2015, TiGenix completed a Phase I sepsis challenge trial demonstrating the favourable 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) (the SEPCELL project). The trial is expected to enroll a total of 180 patients across Europe.
Others: * On November 2, 2015, TiGenix, an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platforms, announced that the SEPCELL project has been awarded a €5.4 million grant from the European Commission under Horizon 2020, the European Union\'s framework programme for research and innovation, to conduct a clinical Phase Ib/IIa trial of Cx611 in patients with severe sepsis secondary to severe community-acquired pneumonia (sCAP). TiGenix, as project coordinator, will lead the project, receiving €1.3 million of non-dilutive funds, and will be responsible for managing the remaining €4.1 million to fund the activities of the consortium\'s clinical and research partners.
Therapeutic area: Infectious diseases
