(This article first appeared on tfscro.com)
TiGenix has selected TFS International (TFS) for the first clinical trial (SEPCELL) to use stem cell therapy in the treatment of severe sepsis secondary to severe community acquired pneumonia (sCAP).
The SEPCELL project is a randomized, double-blind, placebo-controlled, Phase Ib/IIa study in severe sepsis secondary to severe CAP (sCAP). Subjects in the trial must have sCAP requiring mechanical ventilation and/or vasopressors. The trial is expected to enroll 180 patients, and will be conducted at approximately 50 centers throughout Europe. Subjects will be randomized 1:1 to receive active investigational product or placebo on days 1 and 3. All patients will also be treated with the standard of care, which generally includes antibiotics and anti-inflammatory drugs. The primary endpoint is the number, frequency and type of adverse events during a 90 day period. Secondary endpoints include the reduction in the duration of mechanical ventilation and/or vasopressors, overall survival, clinical cure of sCAP, and other infection-related endpoints.
This study will assess the safety and efficacy of expanded allogeneic adipose-derived stem cells (eASCs) delivered intravenously. TFS medical and operational expertise in sepsis studies and strong experience with hospital-based trials were decisive factors for TiGenix selecting TFS.
“TFS is proud to have been selected by TiGenix as their clinical development partner in this study. Our medical and operational expertise in sepsis studies and strong experience with hospital-based trials were decisive factors in our favor”, states Patricia A. Mosher, EVP Clinical Development, at TFS. “TFS is very well positioned to work with small- to midsized biopharma and can provide valuable support from the early planning stages throughout the entire clinical development process.”
“TFS is exactly the mid-size global full services provider with the dynamism, expertise and track record of quality trials needed for our study. Our daily collaboration demonstrates that we selected the right partner for this study in severe sepsis, which was awarded a grant from the European Commission under Horizon 2020, the European Union’s framework programme for research and innovation,” said Dr Marie Paule Richard, Chief Medical Officer at TiGenix.
For further information please contact:
Montserrat Barceló Riera
Chief Operating Officer, COO
Phone: +46 (0)46 280 18 00
Information about TFS
TFS International is the leading, mid-size clinical Contract Research Organization (CRO) providing global clinical development solutions. Founded in 1996 in Sweden, TFS currently operates in over 25 countries throughout Europe and North America and employs more than 750 professionals. TFS core therapeutic areas of expertise are Oncology, Immunology, Dermatology, Ophthalmology, CNS, Cardiology and Endocrinology. Through two business areas, TFS Develop™ and TFS People™, TFS provides services worldwide as end-to-end solutions or tactical functional services. Detailed information about TFS, its business offerings, global locations and recent press releases can be obtained through www.tfscro.com
Information about TiGenix
About Severe Sepsis
Sepsis is a systemic inflammatory response to infection, which includes activation of leukocytes, the release of cytokines and chemokines, the activation of the coagulation system and activation of endothelial cells. An international consensus panel proposed the term ‘severe sepsis’ to describe instances in which sepsis is complicated by acute organ dysfunctions, while the term ‘septic shock’ was defined as sepsis complicated by either hypotension that is refractory to fluid resuscitation or by hyperlactatemia. Severe sepsis and septic shock have a significant and increasing impact on public health, and are among the leading causes of mortality in intensive care units. The epidemiology of sepsis, severe sepsis and septic shock shows an incidence of 3 cases per 1,000 population and is increasing due to the ageing of the population, an increase in drug-resistant bacteria and the weakening of the immune system caused by several factors.
About Cx611 in Severe Sepsis
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 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) which is expected to enroll 180 patients across Europe (the SEPCELL project). SEPCELL has been awarded a €5.4M grant by the European Union under the Horizon 2020 Research and Innovation Programme under Grant Agreement 681031.
TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Two products from the adipose-derived stem cell technology platform are currently in clinical development. Cx601 is in Phase III for the treatment of complex perianal fistulas in Crohn’s disease patients. Cx611 has completed a Phase I sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product, AlloCSC-01, is currently in a Phase II clinical trial in acute myocardial infarction (AMI). In addition, the second product candidate from the cardiac stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being developed in a chronic indication. TiGenix also developed ChondroCelect, an autologous cell therapy product for cartilage repair of the knee, which was the first Advanced Therapy Medicinal Product (ATMP) to be approved by the European Medicines Agency (EMA). From June 2014, the marketing and distribution rights of ChondroCelect were exclusively licensed to Sobi for the European Union (except for Finland, where it is distributed by the Finnish Red Cross Blood Service), Norway, Russia, Switzerland and Turkey, and the countries of the Middle East and North Africa. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain).
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