Trial will evaluate local administration of adipose tissue-derived mesenchymal stem cells against complex anal fistulas in Crohn disease patients.

TiGenix’ recently acquired subsidiary, Cellerix, has secured a €4.95 million soft loan from the nonprofit Madrid Network, to support Phase III development of lead expanded allogeneic adult stem cell product. Cellerix’ lead product Cx601 is based on the firm’s expanded adipose tissue-derived mesenchymal stem cell (eASC) platform. The cells suspension is in development for local administration to treat complex anal fistulas in patients with Crohn disease. Madrid-based Cellerix claims the treatment acts by controlling inflammation to promote natural closure of the lesion.

Cx601 has been granted organ drug designation in the EU, and a Phase III study is projected to start in 2012. The firm says the EMA’s Committee for Medicinal Products for Human Use has indicated that the proposed single Phase III study may be sufficient to support a marketing approval authorization. Positive data from a Phase II study in 22 patients were reported in February.

“This financing will cover a significant part of the development costs of Cx601,” comments Eduardo Bravo, TiGenix CEO. “Importantly, it allows us to finance the Phase III independently and retain much more of its value in potential partnering agreements.”

The firm’s clinical pipeline includes Cx501, a cell therapy for treating the hereditary skin condition epidermylysis bullosa (EB). Cx501 combines both healthy fibroblasts from donors, and the patient’s own keratinocytes, to generate a chimeric skin equivalent comprising dermal and epidermal layers. The product has been granted orphan drug designation in Europe and has been evaluated in a Phase II study.

Cellerix is separately developing locally administered eASC products for the treatment of intestinal bowel disease (Cx602), and for the treatment of osteoarthritis (Cx603). Both programs are at the preclinical stage, although the firm projects that the IBD program may move into the clinic in the short-mid-term, and a potentially development partner is being sought.

The eASC platform has in addition led to the development of two products for systemic delivery: Cx611, for the treatment of rheumatoid arthritis, and Cx621, for the treating inflammatory and autoimmune diseases. A Phase I/IIa trial with Cx611 has been given regulatory go-ahead, and a short-term Phase I/IIa study with Cx621 is also in the planning.

Cellerix claims ASCS can inhibit immune cell activation, proliferation and function through the selective induction of regulatory T cells. The firm is thus developing an immunotherapy platform to enable the large-scale production of regulatory T cells in the presence of ASCs. Lead program, Cx911, is in preclinical development.

TiGenix and Cellerix announced their share-based merger in February, in a deal that valued the Spanish firm at some €58 million.

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