On July 4, 2016, TiGenix entered into a licensing agreement with Takeda, a large pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to commercialize Cx601 for complex perianal fistulas outside the United States. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain). About Cx601 Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) locally injected. Cx601 is an investigational agent being developed for the treatment of complex perianal fistulas in Crohn’s disease patients with inadequate response to at least one conventional or biologic therapy including antibiotics, immunosuppressants, or anti-TNF agents. Crohn’s disease is a chronic inflammatory disease of the intestine and patients can suffer from complex perianal fistulas for which there is currently no effective treatment. In 2009, the European Commission granted Cx601 orphan designation for the treatment of anal fistulas, recognizing the debilitating nature of the disease and the lack of treatment options. Cx601 has met the primary end-point in the Phase III ADMIRE-CD study in Crohn’s disease patients with complex perianal fistula, a randomized, double-blind, placebo-controlled trial run in Europe and Israel and designed to comply with the requirements laid down by the EMA. ‘Madrid Network’ issued a soft loan to help finance this Phase III study, which was funded by the Secretary of State for Research, Development and Innovation (Ministry of Economy and Competitiveness) within the framework of the INNTEGRA plan. The study’s primary endpoint was combined remission, defined as clinical assessment at week 24 of closure of all treated external openings draining at baseline despite gentle finger compression, and absence of collections >2cm confirmed by MRI. In the ITT population (n=212), Cx601 achieved statistically significant superiority (p=0.024) on the primary endpoint with 50% combined remission at week 24 compared to 34% in the placebo arm. Efficacy results were robust and consistent across all statistical populations.
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Thursday, December 22 2016 1:17 PM EST2016-12-22 18:17:35 GMT Updated: Thursday, December 22 2016 6:29 PM EST2016-12-22 23:29:57 GMT Ivanka Trump was flying out of JFK with her kids and other cousins when a passenger reportedly started screamed at her. (Source: AP/John Minchillo) An anti-Trump passenger spotted Ivanka Trump on a Jet Blue flight and started screaming at her. Thursday, December 22 2016 6:46 AM EST2016-12-22 11:46:05 GMT Updated: Thursday, December 22 2016 6:52 AM EST2016-12-22 11:52:50 GMT A man sustained minor burns on his thigh and hand after an e-cigarette exploded in his pocket while on the bus. Thursday, December 22 2016 3:14 AM EST2016-12-22 08:14:43 GMT Updated: Thursday, December 22 2016 3:20 AM EST2016-12-22 08:20:05 GMT Strangers helped a woman in need after they mistakenly connected on Facebook. TORONTO (AP) — A 10-year-old girl died has died after falling ill aboard a trans-Atlantic Air Canada flight. The airline says Toronto-to-London flight AC868 diverted to Shannon, Ireland, on Saturday after the child suffered a medical problem. Air Canada says a doctor and a nurse were on board the plane and helped the flight crew to assist the child. Emergency crews met the aircraft when it landed in Ireland, but Air Canada says local medical authorities pronounced the girl dead. The Boeing 787 with 230 passengers on board continued on to London.
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