Date: 2011-10-03
Type of information: Subvention
Company: Tigenix (Belgium)
Investors: Madrid Network
Amount: €4.95 million
Funding type: loan
Planned used: This loan will be used to finance the company\'s phase III study for complex perianal fistulas in Crohn\'s disease patients. 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 program is currently ongoing and recruitment is expected to start in the first half of 2012.
Others: TiGenix has announced that its wholly-owned subsidiary Cellerix SA is to receive a €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 loan will be made available in three tranches, of which the first 40% 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.
Therapeutic area: Allergic diseases - Immunological diseases
