BioWorld International Correspondent

Belgian regenerative medicine specialist TiGenix NV raised €12 million in its first funding round, money it will use to complete a Phase III trial of its ChondroCelect cartilage repair platform and to advance earlier-stage programs in drug discovery and tissue engineering.

ING Private Equity, part of ING Group NV, of Amsterdam, the Netherlands, led the round and now is the Louvain-based company's largest shareholder. Capricorn Venture Partners, also of Louvain, acted as co-lead, while the other participants were Auriga Partners S.A., of Paris, and Fagus N.V., of Brussels, Belgium. Gemma Frisius Fund, the seed capital fund of the University of Louvain, increased its stake in the company, while the University of Ghent became a shareholder through the conversion of a bridge loan they had jointly made available to TiGenix.

The company was formed in 2000 as a spin-off from the two universities. Its scientific founder is Frank Luyten, who chairs the department of rheumatology at Louvain. Co-founder and CEO Gil Beyen was previously a partner specializing in health care at the Brussels office of law firm Arthur D. Little.

ChondroCelect, Beyen told BioWorld International, entered a Phase III study in March 2002, even though it was not mandatory.

"We wanted to do this trial because we think it's key to really proving this product as a medicinal product, and in view of reimbursement," he said. Results of the trial, which will involve between 100 and 120 subjects in Belgium, the Netherlands, Germany and France, will be reported in late 2004 or early the following year. The aim is to demonstrate superior efficacy to microfracture, the standard therapy for treating cartilage damage occurring through conditions such as osteoarthritis. The therapy involves drilling tiny holes through the patients' cartilage and into the underlying bone marrow in order to enable stem cells to migrate to the damaged area and differentiate into cartilage cells. About 3,000 such procedures are performed in Belgium every year, Beyen said.

ChondroCelect represents an effort to provide a clinically validated quality control system for a newer, alternative procedure, autologous chondrocyte implantation (ACI). That involves harvesting healthy chondrocytes (cartilage-producing cells) from the patient's joint and cultivating them in vitro before reintroducing them to the damaged area.

"It's not difficult to cultivate cartilage cells, but to keep the viability and potency and phenotype of these cells is really a challenge," Beyen said.

TiGenix has identified some 210 cell-surface markers - 150 positive and 60 negative - that act as predictors of a cell's ability to stably produce the hyaline-type cartilage found in joints and in other parts of the body. It has deployed a subset of eight of these - six positive and two negative - in the ChondroCelect platform. The company has developed a GMP facility for cultivating populations of chondrocytes derived from patient biopsies. It does not need to use cell-sorting techniques for isolating the desired cell types, Beyen said, as it has developed cell culture enrichment techniques that impose the appropriate selection.

ChondroCelect already has been launched in Spain and Portugal, where it is being marketed by Industrias Quir rgicas de Levante s.l., of Valencia, Spain. Beyen said he expects sales to start by the end of the month. A second generation of the technology, which will involve the cultivation of stem cells that can be isolated from synovial fluid instead of solid cartilage, is in preclinical development.

The company is seeking a partner with which to offer a genetic diagnostic service that would use an expanded set of molecular markers. It has initiated drug discovery efforts, based around its knowledge of the signaling pathways associated with cartilage formation.

"We have selected some targets," Beyen said. It also will seek a partner for that activity. It has additional early stage programs in heart valve and skeletal muscle repair.

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