Belgium is a real pioneer in developing stem cell therapies. TiGenix pushes this precursor position even further by presenting good results from a Phase III of its stem cell therapy (Cx601) treating Crohn’s disease.

UPDATE (article originally published on 24/8/2015): TiGenix’s Phase III results were now published in The Lancet.

Julián Panés, the global coordinator of the study, commented: ““The Lancet is one of the most highly regarded and well known medical journals in the world; we are very delighted to have the Cx601 data selected by this prestigious publication.”

See the end of the article for more details of the candidate’s development.

Founded in 2000, Leuven-based TiGenix develops stem cell therapies for autoimmune and inflammatory diseases. These are based on expanded stem cells extracted from the patient’s adipose tissue. The company has five products in development and one on the market, as shown below.


TiGenix’ pipeline. © TiGenix

Since its €46m IPO in 2007 at a price of €5.56, the company’s stock decreased dramatically, even though it launched the first cell-based product on the European market in 2009. In 2013, the stock price went almost negative by reaching 22 cents.

However, TiGenix’s lead candidate has the potential to change course, as it completed Phase III. Cx601 is designed to treat complex perianal fistulas in Crohn’s disease patients, for which there is currently no effective treatment. In week 24, 49.5% of the patients that were treated with Cx601 experienced a remission, compared to 34.3% in the placebo arm (this placebo is quite effective too …).

TiGenix wants to submit approval request in Europe in the first quarter of 2016 and starts its Phase III in the US. With both market authorizations, Cx601 could improve the life of more than 100.000 patients every year.


The Tigenix building in Leuven.

The positive results represent a crucial milestone for TiGenix, which is reflected by an increase of 22% of its stock price. This leads to a market cap of €116M. Considering its late-stage pipeline and its product on the market, this value seems really low. An analyst from SeekingAlpha even claims that it is ‘deeply undervaluated‘.

This successful Phase III adds TiGenix to the pioneering companies in Belgium developing cell-based therapies. Nasdaq-listed Celyad is in Phase III with its treatment for ischemic heart failure, Promethera‘s drug for urea cycle disorders is in Phase IIb and Bone Therapeutics has even two treatments in Phase IIb/III. All together, they could place Belgium and Europe as the world leader in cell therapies.


TiGenix has also disclosed additional results of a 52-week follow-up study, where the effect of Cx601 was maintained during a year.

According to its plan, TiGenix submitted a marketing authorization application to the EMA in the first quarter of 2016. A decision could be expected in 2017. Last month, the rights for the candidate’s development and commercialization were licensed to Takeda (Japan).

 TiGenix is now focusing on US development, with plans for a Phase III trial (expected to start in 2017) and for an FDA’s Fast Track Designation.

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