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Cx601 stem cell therapy maintains remission of complex perianal fistulas through 1 year in Crohn's
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Patients with Crohn’s disease achieved sustained remission of treatment-refractory complex perianal fistulas through 52 weeks after treatment with Cx601 stem cell therapy, according to results from the ADMIRE-CD trial presented at the 12th Congress of the European Crohn’s and Colitis Organization.
Cx601 (TiGenix/Takeda) is a suspension of expanded allogeneic adipose-derived mesenchymal stem cells (eASC) delivered locally by intra-lesional injection, which is in development for the treatment of complex perianal fistulas in Crohn’s disease patients.
“These data highlight that the efficacy and safety of a single administration of Cx601 were maintained during 1 year of follow up,” Marie Paule Richard, MD, chief medical officer at TiGenix, said in a press release. “It is important to also note that the definition of combined remission used in the ADMIRE-CD study, which includes both clinical and radiological assessment by MRI, is more stringent than the criteria commonly used in previous large scale, randomized clinical trials evaluating perianal fistulas in Crohn’s disease, based only on clinical assessment.”
In this phase 3, double blind, randomized controlled trial, Julián Panés, MD, of the Hospital Clinic Barcelona in Spain, and colleagues randomly assigned 212 patients with inactive or mildly active luminal Crohn’s disease and treatment-refractory complex perianal fistulas to receive a single Cx601 injection or placebo, both with standard of care treatment. The surgeon who administered the treatment was unmasked, while the gastroenterologist who evaluated the therapeutic effect was masked to treatment.
Julián Panés
Panés and colleagues previously reported interim week 24 data from this trial at last year’s ECCO congress.
At week 24, a greater proportion of patients treated with Cx601 achieved clinical and radiological combined remission (51.5% vs. 35.6% for controls; P = .021), and these benefits were maintained through week 52 (56.3% vs. 38.6%; P = .01) in the modified intention-to-treat population. A greater proportion also maintained clinical remission at week 52 (59.2% vs. 41.6%; P = .013).
In addition, among patients who achieved clinical and radiological combined remission at week 24, more of the Cx601-treated patients avoided relapse at week 52 compared with controls (75% vs. 55.9%).
The number of patients with treatment-related adverse events (non-serious and serious) and those who discontinued due to adverse events were comparable between treatment and control groups.
“Perianal fistulizing Crohn’s disease is difficult to treat with currently available therapies and often leads to pain, swelling, infection and incontinence,” Asit Parikh, MD, head of Takeda’s gastroenterology therapeutic area unit, said in the press release. “Existing therapies are limited and associated with complications and a high failure rate. Cx601 may offer patients an alternative treatment option.”
The European Commission issued orphan drug designation to the investigational compound in 2009 for the treatment of anal fistulas, and TiGenix announced it submitted a marketing authorization application to the European Medicines Agency in March 2016, with a decision expected this year. The Swiss Agency for Therapeutic Products also issued orphan drug status to the compound in September 2016, and TiGenix plans to begin a global pivotal phase 3 trial for U.S. registration and apply for fast track status in the U.S. this year, according to the press release. – by Adam Leitenberger
Reference:
Panes J, et al. Abstract OP009. Presented at: ECCO Congress; February 15-18, 2017; Barcelona.
Disclosures: Panés and some of his colleagues report financial relationships with Takeda and TiGenix. Please see the ECCO disclosure database for a full list of all other researchers’ relevant financial disclosures. Parikh is employed by Takeda and Richard is employed by TiGenix.