Cx611 / Takeda - LARVOL DELTA

Effect of mesenchymal stem cells on the host response in severe community-acquired pneumonia. (PubMed, Thorax) - "Cx611 treatment enhanced several endothelial cell and procoagulant response plasma biomarkers, and led to increased expression of pathways related to innate immunity, haemostasis and apoptosis. Cx611 infusion in sepsis due to CABP is associated with broad host response alterations."

Journal • Critical care • Infectious Disease • Pneumonia • Respiratory Diseases • Septic Shock

The safety and efficacy of stem cells for the treatment of severe community-acquired bacterial pneumonia: A randomized clinical trial. (PubMed, J Crit Care) - P1/2 | "Cx611 was well tolerated in severe CABP. These data provide insights for future stem cell clinical study designs, endpoints and sample size calculation."

Clinical • Journal • Cardiovascular • Critical care • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases • Septic Shock

A phase Ib/IIa, randomised, double-blind, multicentre trial to assess the safety and efficacy of expanded Cx611 allogeneic adipose-derived stem cells (eASCs) for the treatment of patients with community-acquired bacterial pneumonia admitted to the intensive care unit. (PubMed, BMC Pulm Med) - P1/2 | "SEPCELL is the first trial to assess the effects of eASCs in sCABP. The data generated will advance understanding of the mode of action of Cx611 and will provide evidence on the safety, tolerability and efficacy of Cx611 in patients with sCABP. These data will be critical for the design of future confirmatory clinical investigations and will assist in defining endpoints, key biomarkers of interest and sample size determination."

Clinical • Journal • P1/2 data • Critical care • Infectious Disease • Pneumonia • Respiratory Diseases • Septic Shock

Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CDX 6114 in PKU Patients (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Nestlé; N=36 ➔ 0; Trial completion date: Aug 2021 ➔ Dec 2021; Initiation date: Apr 2020 ➔ Dec 2020; Not yet recruiting ➔ Withdrawn; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Trial withdrawal • Metabolic Disorders • Phenylketonuria • Rare Diseases

Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU) (clinicaltrials.gov) - P1; N=18; Completed; Sponsor: Nestlé; Recruiting ➔ Completed

Clinical • Trial completion • Metabolic Disorders • Phenylketonuria • Rare Diseases

Cx611-0204 SEPCELL Study (clinicaltrials.gov) - P1/2; N=84; Active, not recruiting; Sponsor: Tigenix S.A.U.; Trial completion date: Jul 2020 ➔ Dec 2021; Trial primary completion date: Mar 2020 ➔ Jul 2020

Clinical • Trial completion date • Trial primary completion date • Critical care • Infectious Disease • Pneumonia • Respiratory Diseases

Cx611-0204 SEPCELL Study (clinicaltrials.gov) - P1/2; N=84; Active, not recruiting; Sponsor: Tigenix S.A.U.; Trial completion date: Dec 2021 ➔ Jul 2020

Clinical • Trial completion date • Infectious Disease • Pneumonia • Respiratory Diseases

Cx611-0204 SEPCELL Study (clinicaltrials.gov) - P1/2; N=84; Active, not recruiting; Sponsor: Tigenix S.A.U.; N=180 ➔ 84; Trial completion date: Apr 2022 ➔ Dec 2021

Clinical • Enrollment change • Trial completion date • Infectious Disease • Pneumonia • Respiratory Diseases

TiGenix : Full year 2013 financial results (GlobeNewswire) - "TiGenix expects to finalise and announce the next steps of the development plan in the coming weeks....Cx611: development plan for new indications to be presented."

Anticipated new indication • Pipeline update • Rheumatoid Arthritis

TiGenix: Corporate Presentation (TiGenix) - “Favorable safety profile of all three doses of Cx611”; “Only on patient experienced a serious adverse event leading to discontinuation of the treatment, All other side effects were mild and transient: most common related adverse events in the Cx611+DMARD group: fever (15%), headache (9%), asthenia (6%)”; “Encouraging therapeutic activity”

P1/2 data • Rheumatoid Arthritis

Cx611-0204 SEPCELL Study (clinicaltrials.gov) - P1/2; N=180; Active, not recruiting; Sponsor: Tigenix S.A.U.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CDX 6114 in PKU Patients (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Nestlé

Clinical • New P1 trial

Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU) (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Nestlé; Trial completion date: Dec 2019 ➔ Aug 2020; Trial primary completion date: Dec 2019 ➔ Jun 2020

Trial completion date • Trial primary completion date

Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU) (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Nestlé

Clinical • New P1 trial

A Study of the Safety and Tolerability of CDX-6114 in Healthy Volunteers (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Codexis Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Cx611-0204 SEPCELL Study (clinicaltrials.gov) - P1/2; N=180; Recruiting; Sponsor: TiGenix S.A.U.; Trial completion date: Oct 2020 ➔ Apr 2022; Trial primary completion date: Mar 2019 ➔ Jul 2020

Clinical • Trial completion date • Trial primary completion date