USPTO issues key US patent to TiGenix

USPTO issues key US patent to TiGenix for the use of adipose-derived stromal cells in the treatment of fistulas

TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platform of allogeneic expanded adipose-derived stem cells in inflammatory and autoimmune diseases, announced that the United States Patent and Trademark Office (USPTO) has issued US Patent 8,999,709 relating to the use of an adipose-derived stromal cell population in the treatment of fistula. The patent, entitled "Use of adipose tissue-derived stromal stem cells in treating fistula", expires in 2030 and provides coverage for the company's lead development product, Cx601, in the key US market.

 "The issuance by the USPTO of this patent is a key achievement in our strategy for the development and commercialisation of Cx601 in the American market", said Wilfried Dalemans, Chief Technical Officer of TiGenix. "It further builds our intellectual property position in the use of eASCs in the indication we are pursuing. As such, it is an essential component of the business case for making the product available to patients in the US."

The issuance of this patent further strengthens TiGenix's intellectual property portfolio of 24 patent families which now includes 15 granted patents related specifically to its eASC platform. The pending and granted patents in TiGenix's intellectual property portfolio include patent families that are directed to its eASC platform; more specifically, to eASC compositions and therapeutic applications as well as to cell therapy delivery mechanisms and other eASC technology improvements.

Cx601 is a solution of expanded adipose-derived stem cells (eASCs) for local injection currently in Phase III of clinical development for the treatment of complex perianal fistulas in patients with Crohn's disease. Clinical results from the on-going European Phase III trial are expected in the third quarter of 2015. Following the positive feedback received at a meeting with the Center for Biologics Evaluation and Research within the Food and Drug Administration (FDA), TiGenix is moving ahead with the development of Cx601 for the United States market. The Company has submitted to the FDA the required documentation for a Special Protocol Assessment (SPA) of its pivotal Phase III trial design for Cx601 in the treatment of complex perianal fistulas in patients with Crohn's disease in the United States. Agreement with the FDA on the SPA will ensure that the trial design is aligned with the FDA's requirements for the future approval of Cx601. The Phase III trial in the US, if successful, together with positive data from the European Phase III trial, would enable the Company to file a biologics license application (BLA) with the FDA. The Company expects to complete the process of manufacturing technology transfer to its US-based contract manufacturing organisation (CMO), Lonza, in the first half of 2016, after which the Phase III trial of Cx601 in the US can begin.