Cx601 is a local administration of expanded adipose-derived stem cells (eASCs) for the treatment of complex perianal fistulas in Crohn’s disease patients. The treatment is administered as a single dose and has been proven to have long-term efficacy in the healing of complex perianal fistulas in Crohn’s disease patients (ADMIRE-CD study completed in 2015 with positive 2 year follow-up data). The 24-week results of this trial were published in The Lancet in July 2016.
Cx601 has been designated as an orphan drug by the EMA and SwissMedic, in Switzerland.
On 4th July 2016, Takeda Pharmaceuticals acquired an exclusive right to develop and commercialize Cx601 for complex perianal fistulas in Crohn’s disease patients outside of the U.S. Takeda is a leading pharmaceutical company in the gastroenterology space. TiGenix retains full rights to the product in the US as well as to the development of Cx601 in other indications.
Crohn’s disease is a chronic inflammatory disease of the intestine. A complication of the disease is the development of complex perianal fistulas. A perianal fistula is an abnormal connection between the perianal space and the outside skin surface which causes a significant negative impact on quality of life. A fistula is considered to be complex when its treatment involves a high risk of causing anal incontinence, the fistulous tract crosses more than 30% of the external sphincter, several tracts are found, it is recurrent, or when the patient has incontinence, local irritation, or Crohn’s disease.
Complex perianal fistulas in patients suffering from Crohn’s disease tend to occur in individuals between the ages of 20 and 40, though 10-15% of patients are diagnosed before adulthood.
Current treatment options for complex fistulas in patients with Crohn’s disease include the use of antibiotics, immunosuppressants, anti TNFs and surgery. However, these treatment options are marked by poor long term efficacy and considerable safety issues: treatment with anti TNFs is associated with low remission and high relapse as well as with safety concerns when they are used long term. In the case of surgery, the treatment is associated with a high risk of recurrence and of complications which can include incontinence, non-healing wounds and abscesses.
TiGenix is on track to gain EU approval for Cx601 in 2017 based on the pivotal phase III ADMIRE-CD results published partly in the Lancet.
We are preparing for the start of a global Phase III trial intended to support a future U.S. Biologic License Application (BLA) in the United States.