Date: 2011-12-20
Type of information:
phase: 1
Announcement: authorisation
Company: Tigenix (Belgium)
Product: Cx621
Action mechanism: Cx621 is an allogeneic expanded adipose stem cells product candidate for the treatment of autoimmune diseases via a proprietary technique of intra-lymphatic or intra-nodal administration. The intra-lymphatic route is expected to offer significant benefits, as the systemic effect of the cells has been shown to be mediated at the level of the secondary lymphoid organs, the draining lymph nodes and spleen. Recent preclinical and clinical experience with vaccines and antitumor agents indicate that the lymph nodes may provide a feasible and safe route of administration. Indeed, the subcutaneous lymph nodes are readily visible by ultrasound and injection of a superficial lymph node in the groin area can be performed quickly and without prior training. Patients rated intra-lymphatic injection less painful than venous puncture (Senti et al., 2008).
Disease: Autoimmune diseases
Therapeutic area: Autoimmune diseases
Country:
Trial details:
Latest
news: TiGenix announced that it has obtained all the required approvals to start the company\'s Phase I clinical trial to assess the safety of intra-lymphatic administration of its expanded adipose stem cells product (Cx621). The Phase I will enroll 10 healthy volunteers and the company expects the last volunteer to be dosed in April, with final results reported by June 2012. Cx621 aims to capitalize on the benefits of TiGenix\'s proprietary approach of intra-lymphatic administration to treat autoimmune disorders.
