Biopharmaceutical company TiGenix NV announced the enrollment of the first participant in their phase 1 study designed to assess Cx611 for treatment of severe sepsis. The trial will help advance the company’s development and commercialization of medication using their proprietary allogeneic platform, and expand adipose-derived stem cells (eASC’s) for use in treating inflammatory and autoimmune diseases. The drug has already shown promise in curtailing inflammation in Crohn’s disease.
The company is evaluating Cx611, which is an intravenously-administered product derived from allogeneic eASC’s, in a placebo-controlled dose-ranging study that will enroll 32 healthy male participants. The volunteers will be randomly administrated with either Cx611 or placebo in a 3:1 ratio.
The study was designed by TiGenix NV as a proof of principle investigation to assess the efficacy of Cx611 in healthy patients who are challenged by bacterial endotoxin (lipopolysaccharide), a condition that elicits an inflammatory response inducing sepsis-like clinical symptoms.
“The mortality rate for patients with severe sepsis is over 50 percent”, explained the Chief Medical Officer of TiGenix, Marie Paule Richard. “We believe that by adding Cx611 to the current standard of care, TiGenix can reduce this grave loss of life. TiGenix expects to complete the trial by the third quarter of 2015, and then to follow up with a Phase II trial of Cx611 as an add-on therapy to the standard of care in patients with severe sepsis.”
The study is the beginning of the TiGenix NV efforts in developing a therapeutic for severe sepsis. The company believes that primary endpoints will be crucial to identify vital signs and symptoms, laboratory measures and functional assays of innate immunity. In addition, they also announced that the company is planning to move a study for early rheumatoid arthritis into its phase II of clinical development during 2015.
The European company has recently completed successfully the patient enrollment for their phase III clinical trial of Cx601, which their leading candidate medication for complex perianal fistulas for the treatment of patients who suffer from Crohn’s disease. The main purpose of the research is to achieve remission of fistulous disease in patients with Crohn’s disease, which is complete healing of the perianal tracts.