Cx611 is a systemic injection of expanded Adipose-derived Stem Cells (eASCs). The product is currently being evaluated as a treatment for severe sepsis – a major cause of mortality in hospitals in the developed world – in the SEPCELL phase I/II trial which is currently enrolling patients. Further information on the trial can be found at www.sepcell.eu
MEDICAL NEED AND POTENTIAL MARKET
Sepsis is a potentially life-threatening complication of infection leading to systemic inflammation and organ failure. The incidence of sepsis is increasing due to an ageing population, an increase of drug-resistant bacteria and weakening of the immune system caused by e.g. HIV infection, cancer treatments or transplant drugs. In fact, it represents a higher incidence and mortality than HIV, Breast and Prostate Cancer combined. Between 15M to 19M sepsis cases occur worldwide each year (The Lancet Infectious Diseases; Volume 12; issue 2) with mortality reaching 50% for severe sepsis and up to 80% in septic shock (Martin GS Expert Rev Anti Infect Ther. 2012 June).
Severe sepsis has a significant and increasing impact on public health, and is one of the leading causes of mortality in the intensive care units in the developed world.
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 stabilize 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.
TiGenix believes that Cx611’s novel mechanism of action may offer an innovative alternative to the treatment of severe sepsis.
In May 2015, TiGenix completed a Phase I sepsis challenge trial (the CELLULA trial) demonstrating the favorable safety and tolerability profile of Cx611.
Based on the results of this study, TiGenix designed the SEPCELL Phase Ib/IIa study in severe sepsis secondary to severe community-acquired pneumonia (sCAP). This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 681031 and is being carried out through the SEPCELL consortium, which gathers six partners from four European countries. (see www.sepcell.eu for more information).
The SEPCELL study is a randomized double-blind placebo controlled multicenter study with two parallel arms. We aim to recruit 180 patients in at least 50 centers in at least four countries, with 90 patients in each group.
The primary endpoint of the study is safety as defined by any adverse event and potential immunological host responses against the administered cells.
Secondary endpoints include reduction in the duration of either or both of mechanical ventilation or vasopressors needed, improved survival, clinical cure of the community-acquired bacterial pneumonia and other infection related endpoints. Data is expected to be available in 2019.
The SEPCELL consortium gathers six partners from four European countries (Spain, France, Netherlands and Belgium), including TiGenix SAU and TiGenix NV. The consortium is made up of a combination of research institutes, medical entities and biotech oriented SMEs, thus bringing together the necessary competence and critical mass in terms of expertise and resources that will ensure the achievement of the project’s goals.