Efficacy of a novel compound in a humanized mouse model of psoriasis

Psoriasis is a highly prevalent disease with great impact on the quality of
life of the patients. Current treatments are far from ideal. The development of
new compounds requires validation in an animal model, however, many differences
exist between the skin of most animals and humans. TNO Life Sciences has
acquired expertise in the past year in transplanting human psoriasis skin onto
a mouse. Thereby, we are able to perform preclinical testing of compounds for
psoriasis. Non-laesional skin is transplanted onto a mouse and after
engraftment injection with autologous T-cells synchronizes the psoriatic
process. Scientific background information can be read in Appendix 3. Since the
study involves pre-clinical testing, patients will not experience a direct
benefìt from participation.

ln this study the effect of 1 novel compound on the development of psoriasis in
the humanized mouse model is
investigated.

A pharmaceutical company has asked TNO to test a potential new therapy for
psoriasis in our humanized mouse
model of psoriasis. Besides animal welfare approval, we also need medical
ethical clearance for obtaining skin
biopsies and blood from psoriasis patients. The skin will be transplanted onto
mice after which autologous T-cells
(isolated from the blood of patients) will be injected into the graft to
synchronize development of psoriasis. As indicated
in the study protocol (Appendix 1), 4 skin punch biopsies will be obtained from
non-lesional skin as well as 6 vials of
blood (ca. 8 ml each).

TNO has arranged insurance for the patients participating in this study.
However, medical risks are very low. A week
after obtaining skin and blood samples, the stitches will be removed at the
research center (PT&R) and a check will
take place. With the consent of the patient, the medical practitioner of each
patient will be notified about the
participation.