Systemic administration
Product platform based on expanded adipose tissue-derived mesenchymal cells (eASCs) from allogeneic sources. Two development programs based on different systemic administration routes are currently ongoing:
|
Program |
Administration route |
Indication |
|---|---|---|
|
Cx611 |
Intravenous |
Rheumatoid arthritis |
|
Cx621 |
Intralymphatic |
To be confirmed |
Development of Cx611 and Cx621 is based on data from several animal models showing that eASCs are able to migrate from the implant to the inflammation site and to exert a systemic effect upon cytokine levels. eASCs suppress expression of pro-inflammatory cytokines and promote expression of anti-inflammatory cytokines.
Intravenous administration of eASCs for the treatment of rheumatoid arthritis
Cellerix has achieved positive results in murine models of rheumatoid arthritis showing a long-term therapeutic effect through inhibition of synoviocyte activation in patients with this disease.
Based on these results, Cellerix has prepared a protocol for a Phase I/IIa study of Cx611 for the treatment of rheumatoid arthritis in cooperation with the scientific advisory committee of the company. This study is planned to start in 2011.
Intralymphatic administration of eASCs
In in vivo models, Cellerix has shown that eASCs migrate to lymph nodes and from these to lymphatic organs, in which they increase the number of regulatory T cells, which mediate the therapeutic effect of eASCs. Assuming generation of these Tregs in lymph nodes, Cellerix hopes that direct injection of eASCs into the nodes will allow for a more potent therapeutic effect.
Preclinical studies of treatment of inflammatory and autoimmune diseases with this product under GLP conditions are ongoing. Cellerix plans to start a short-term Phase I/IIa study in an inflammatory/autoimmune indication to be confirmed.