TiGenix reports positive results of Cx621 Phase I
TiGenix announced that it has successfully completed the company's Phase I clinical trial to assess the safety of intra-lymphatic administration of its expanded adipose stem cells product (Cx621). Cx621 aims to capitalize on the benefits of TiGenix's proprietary approach of intra-lymphatic administration to treat autoimmune disorders.
The confirmation of the safety of intra-lymphatic administration of TiGenix's expanded adipose stem cells (eASCs) has potentially important clinical and commercial implications. It opens up the possibility of achieving efficacy at much lower dosage, which would further increase the safety profile of TiGenix's eASCs, while it would simultaneously significantly reduce the cost of goods (COGS) and improve margins. An additional benefit is that the subcutaneous lymph nodes are superficial and readily visible by ultrasound, and thus allow for a rapid and easy injection.
The Cx621 Phase I placebo-controlled trial evaluated two different cell doses in ten healthy volunteers, five males and five females. Physical, analytical and also morphological measures were included. The ten volunteers were randomly assigned to the two cohorts. After treatment of the first volunteer in each cohort and confirmation of tolerability, the remaining volunteers for each cohort were randomized 1:1 to receive Cx621 or placebo. The study treatment consisted of two administrations one week apart, two lymphatic injections each, one in the left and one in the right inguinal lymph node. Volunteers were followed-up during 21 days after treatment to establish safety and tolerability of the treatment.
The final report of the Cx621 Phase I clinical trial confirms that there were no severe adverse events. Reported adverse events were mild and transient, and not related to the study medication. All changes in vital signs and blood analysis tests were within the normal limits. Imaging ecographic data showed increased lymph node size after administrations, with no clinical or symptomatic effect. Visual Analogic Scale (VAS) for pain produced no significant changes in any volunteer. Some subjective, short-lived "sensations" around the injected inguinal zone occurred more frequently in the placebo arm.
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