GODDYN advises TiGenix on SEPCELL project

GODDYN advises TiGenix concerning TiGenix’s role as coordinator of the SEPCELL project. TiGenix (Euronext Brussels: TIG) is an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platforms.

TiGenix announced on 2 November 2015 that the SEPCELL project has been awarded a €5.4M 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).

The SEPCELL project is a Phase Ib/IIa randomised, double-blind, parallel group, placebo-controlled, multicentre study designed 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). The trial is expected to enroll a total of 180 patients across Europe.

Cx611 is an innovative approach to the treatment of severe sepsis, using the immunomodulatory properties of eASCs to target different pathways. Current standard of care is palliative and supportive, primarily aimed at controlling symptoms and treating the underlying infection through the use of anti-inflammatory drugs and antibiotics.

“The award of €5.4M grant to SEPCELL by the European Commission underscores the relevance and innovative character of our project and will allow TiGenix to significantly advance the development of a new therapy for severe sepsis secondary to severe CAP, a life-threatening condition with high mortality rates of around 28-50%” said Dr Marie Paule Richard, Chief Medical Officer of TiGenix.

The unique properties of Cx611 have made SEPCELL one of the few clinical projects to obtain the support of the European Commission under the Horizon 2020 programme. In addition to TiGenix, the SEPCELL consortium comprises the Centre Hospitalier Universitaire of Limoges, the Cliniques Universitaires Saint-Luc in Brussels, the Hospital Clínico San Carlos of the Servicio Madrileño de Salud in Madrid, and the Academic Medical Center of the University of Amsterdam. TiGenix, as project coordinator, will lead the project, receiving €1.3M of non-dilutive funds, and will be responsible for managing the remaining €4.1M to fund the activities of the consortium’s clinical and research partners.

Follow the link to download TiGenix’s press release from TiGenix’s website (external link).