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Last €1.18 EUR
Change Today -0.055 / -4.47%
Volume 4.1M
TIG On Other Exchanges
EN Brussels
As of 11:35 AM 09/4/15 All times are local (Market data is delayed by at least 15 minutes).

tigenix nv (TIG) Snapshot

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09/1/15 - €1.31
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10/16/14 - €0.48
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tigenix nv (TIG) Details

TiGenix NV, a biopharmaceutical company, develops and commercializes cell therapy products. Its pipeline is based on a validated platform of allogeneic expanded adipose-derived stem cells (eASC) targeting autoimmune and inflammatory diseases. The company is developing Cx601, which is in Phase III clinical trials for the treatment of complex perianal fistulas in patients suffering from Crohn’s disease; Cx611, an allogeneic eASC that has completed Phase IIb clinical trial for the treatment of rheumatoid arthritis and Phase Ib trail for severe sepsis; and Cx621, which has completed a Phase I trial for the treatment of intra lymphatic administration of allogeneic eASCs. It has operations in Belgium, the Netherlands, Spain, and internationally. TiGenix NV was founded in 2000 and is headquartered in Leuven, Belgium.

49 Employees
Last Reported Date: 03/27/15
Founded in 2000

tigenix nv (TIG) Top Compensated Officers

Chief Executive Officer, Managing Director an...
Total Annual Compensation: €476.6K
Compensation as of Fiscal Year 2014.

tigenix nv (TIG) Key Developments

TiGenix N.V. - Special Call

To discuss the top-line results of the trial, explain the next steps for Cx601 and the company

TiGenix N.V. Announces Cx601 Meets Primary Endpoint in Pivotal Phase III Trial

TiGenix N.V. announced that its lead compound Cx601 met the primary endpoint in the Phase III ADMIRE-CD trial in Crohn's disease patients with complex perianal fistulas. Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) injected intra- lesionally. A single injection of Cx601 was statistically superior to placebo in achieving combined remission at week 24, in patients with inadequate response to previous therapies, including anti-TNFs. The study results confirm the favourable safety and tolerability profile of Cx601.

TiGenix N.V. Obtains FDA's Endorsement Through Special Protocol Assessment for its Cx601 Phase III Registration Trial in the US

TiGenix NV announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for its Phase III registration trial of Cx601 in the U.S. for the treatment of complex perianal fistulas in Crohn's disease patients. The agreed pivotal trial is a randomised, double-blind, parallel group, placebo-controlled and multicentre study in complex perianal fistulas in Crohn's disease patients. The study will enroll approximately 224 patients to assess the efficacy and safety of Cx601 24 and 52 weeks after a single dose administration of the product. The SPA describes the primary endpoint as combined remission, defined as clinical assessment by week 24 of closure of all treated external openings draining at baseline despite gentle compression, and absence of collections > 2cm confirmed by MRI. This primary endpoint is in line with the one for the European Phase III trial, which results are expected later this quarter. The company expects to complete the process of manufacturing technology transfer to its U.S.-based CMO, Lonza, and thereafter will start its Phase III trial of Cx601 in the U.S. in the second half of 2016.


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