Androclus Therapeutics Announces Publication in Lancet of Results of Tolerogenic Immune Responses to hsp60 Epitopes in Juvenile Idiopathic Arthritis.

SAN DIEGO & MILAN, Italy -- Androclus Therapeutics announced publication in Lancet(a) of immunoscreening results of heat-shock protein 60 (hsp60) derived peptides in patients with juvenile idiopathic arthritis (JIA). Researchers from University of Utrecht, University of California, San Diego, La Jolla Institute for Allergy and Immunology, and Androclus Therapeutics demonstrated that peptides derived from hsp60 could represent novel treatment options to specifically modulate the immune system of patients with JIA. The technology was developed in Professor Albani's laboratory at the University of California, San Diego and has been licensed to Androclus Therapeutics.

JIA (previously called junior rheumatoid arthritis, JRA) is a heterogeneous autoimmune disease characterized by chronic inflammation of one or more joints. It is the most common rheumatic disease of childhood and affects approximately 1 in 1000 children aged 16 and younger.

The findings suggest that JIA results from failure of the regulatory arm of the immune system. Researchers identified hsp60-derived peptides that yielded proliferative T-cell responses in peripheral-blood mononuclear cells (PBMC) of patients with JIA, but not in PBMC from healthy or disease controls. "These peptides could be further tested as a specific therapy for children with JIA and could potentially ameliorate the disease by stimulating regulatory function of the immune system," said Berent Prakken, M.D., Ph.D., Professor of Pediatrics and the leader of the Utrecht group.

"These results support the possibility of modulating autoimmune inflammation with an hsp-related mechanism that is independent of the trigger of autoimmunity. It is also exciting that the immunoscreening technology platform has enabled identification of another therapeutic candidate for the treatment of a naturally relapsing remitting disease, juvenile idiopathic arthritis," said Salvatore Albani, M.D., Ph.D., Professor of Medicine and Pediatrics at the University of California, San Diego.

About Androclus Therapeutics

Androclus Therapeutics is a private clinical stage biotechnology company developing a breakthrough technology platform and novel therapeutics for the treatment of autoimmune and inflammatory diseases.

Androclus' leading drug candidate is an orally administered peptide AT-001 (dnaJP1) for the treatment of rheumatoid arthritis. A Phase II clinical trial of AT-001 will be completed in Q3 2005. Based on the same technology platform, Androclus is developing orally administered therapeutic peptides for the treatment of multiple sclerosis and inflammatory bowel disease, with first clinical trials for both indications expected in 2006.

Compared to existing biologics for the treatment of autoimmune diseases, Androclus' drug candidates are expected to be more selective in targeting autoimmune inflammation, have a better safety profile, a more convenient oral route of administration, and offer a complementary therapeutic approach.

(a) Kamphuis S, Kuis W, de Jager W, et al. Tolerogenic immune responses to novel T-cell epitopes from heat-shock protein 60 in juvenile idiopathic arthritis. Lancet 2005; 366: 50-56.