Stem Cell Therapy for Sepsis in Pneumonia advances to Phase II

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TiGenix has treated the first patient in a new early-stage clinical trial to test its candidate Cx611 as a treatment for sepsis in patients with pneumonia.

TiGenix, based in Belgium, develops stem cell therapies derived from donors. This morning, the first patient was treated in a Phase Ib/IIa clinical trial for its candidate therapy Cx611 in the treatment of severe sepsis. Sepsis occurs when the immune system’s response to infection injures tissues and organs in the body, and it affects over 26 million people worldwide, causing up to 50% of hospital deaths and costing €22B ($24B) annually.

TiGenix is testing the immunomodulatory properties of Cx611 as a method to restore normal levels of immune response in patients with severe sepsis in community-acquired pneumonia. The trial will recruit 180 patients in five European centers, who will receive either placebo or two doses of the experimental treatment in addition to the standard care with antibiotics and anti-inflammatory drugs. In a Phase I trial completed in 2015, Cx611 proved to be safe in healthy volunteers. The treatment consists of donor-derived adipose stem cells delivered intravenously.

Researchers at TiGenix
Researchers at TiGenix

TiGenix’ unique technology seems promising, but its financial situation has been tight for the past years. In addition to a €5.4M grant from the EU’s Horizon 2020, a deal with Takeda and its recent Nasdaq IPO have injected some cash that the company will use to advance its pipeline. Its leading candidate, Cx601, a treatment for perianal fistulas in Crohn’s disease is awaiting approval and will be commercialized by Takeda.

TiGenix has claimed fame by producing the first cell therapy in the European market, ChondroCelect, for the repair of defects in the knee’s cartilage. However, the company recently withdrew it for commercial reasons, mostly the lack of reimbursement in key European countries. By targeting a bigger indication with unmet clinical needs, Cx611 might perform better than TiGenix’ first product and bring the company the revenues it needs to keep developing more cell therapies for a wide range of diseases, from myocardial infarction to rheumatoid arthritis.

Images from Sergei Drozd/Shutterstock, TiGenix

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