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, or eASC's, in inflammatory and autoimmune diseases, issued an update on business and financial progress in the first half of this year today.
eASC technology platform
Patient recruitment for the European Phase III study of Cx601 in complex perianal fistulas in Crohn's disease is 95% complete and is expected to finish ahead of schedule. Final results from the study should now be available earlier than previously expected in Q3 2015, and European filing for marketing authorisation is planned for H1 2016
TiGenix confirmed its strategy for developing Cx601 for the US market
The clinical development plans for Cx611 in early rheumatoid arthritis and severe sepsis were completed and implementation has begun
The licensing of marketing and distribution rights and the sale of the Dutch manufacturing facility was completed
Marketing authorisation for ChondroCelect was renewed by the European Medicines Agency (EMA)
Sales for ChondroCelect increased by 16% compared with the same period last year
Loss for the period from continuing operations decreased by 2% compared with the same period last year
Liquidity position of Euro 19.2 million at 30 June 2014
"We made significant progress in the first half of 2014," said Eduardo Bravo, CEO of TiGenix. "We have transformed the operations of TiGenix to enable the company to fully focus on realising the value in its development pipeline. Our Phase III trial of Cx601 is on track to deliver results earlier than anticipated, and our intravenously administered stem cell product, Cx611, has been endorsed by international clinical experts to move forward in two areas of high unmet medical need and significant commercial potential, early rheumatoid arthritis and severe sepsis."