TiGenix announces that its wholly-owned subsidiary Cellerix SA is to receive a EUR 4.95 million soft loan from the “Madrid Network” to finance the company’s phase III study for complex perianal fistulas in Crohn’s disease patients.

The EUR 4.95 million loan will be made available in three tranches, of which the first 40 per cent upon signing of the agreement. The loan will be repayable in 20 tranches over a period of 10 years starting June 2015 with at a very favourable annual interest rate.

“We are delighted by the support from the Madrid Network for our most advanced pipeline product. This financing facility will cover a significant part of the development costs of Cx601, our lead allogeneic stem cell candidate,” said Eduardo Bravo, CEO of TiGenix. “Importantly, it allows us to finance the phase III independently and retain much more of its value in potential partnering agreements.”

“The Madrid Network is very pleased to support the development of TiGenix’s lead development compound and the company’s forerunner role in the exciting field of cell therapy,” said Aurelio Garcia de Sola, president of the Madrid Network. “We are very committed to continue our support for high-tech innovations to further increase and position our region’s strong research and development capabilities in cutting edge industries.  We would also like to underline the support given to this innovative project by the Autonomous Region of Madrid through the Madrid Network, based on the funds made available by the Ministry of Science and Innovation within the framework of the INNTEGRA programme.”

TiGenix’s most advanced allogeneic stem cell candidate Cx601 is a suspension of expanded allogeneic adult stem cell product derived from human adipose (fat) tissue (expanded Adipose derived Stem Cells or ‘eASCs’) that is delivered locally in the fistula through intra-lesional injection. Cx601 has Orphan Drug designation in Europe. Based on the phase II clinical trial report, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) stated that it considered the presented preclinical data package sufficient for  an  MAA (Market Approval Application) submission. CHMP also indicated that the proposed single phase III study might be sufficient to support an MAA in terms of efficacy. Preparation of the phase III programme is currently ongoing and recruitment is expected to start in the first half of 2012.

TiGenix NV is a leading European cell therapy company with two marketed products, ChondroCelect and ChondroMimetic, and a strong pipeline with clinical stage adult stem cell programmes for the treatment of autoimmune and inflammatory diseases.