A new stem cell-based treatment for Crohn’s Disease, a serious chronic inflammatory disease of the gastrointestinal tract, has had successful results in Phase III trials, the makers of the drug announced.
The drug, designated Cx601, was developed by Takeda Pharmaceutical and cell therapy company TiGenix.
In a 24-week trial, according to test results published in the medical journal The Lancet, the drug was given to a group of patients suffering from perianal fistula, a painful, debilitating condition in which a hole develops between a gland located just inside the anus and the outer skin. “A significantly greater proportion of patients in the treatment group versus the placebo group achieved combined remission at week 24,” the study concluded.
More significantly, TiGenix also said that full-year clinical test data “indicated the potential for efficacy and safety of a single treatment of Cx601 are maintained during a year of follow up.”
The companies explained that Cx601 is meant to treat patients with Crohn’s Disease, which affects about five million people worldwide, who had not responded to at least one other conventional drug or biologic therapy. Because of the serious nature of the disease and the lack of other treatment options, in 2009 Cx601 was given “orphan” designation by the European Commission, which exempts the drug from several requirements related to anti-competition regulations.
The next step in the drug’s testing is another Phase III trial for the treatment of complex perianal fistulas to be carried out in the US beginning next year.