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Androclus Therapeutics Announces Publication of Phase I/IIa Rheumatoid Arthritis Clinical Trial Results

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SAN DIEGO & MILAN, Italy–(BUSINESS WIRE)–May 14, 2004–

Androclus Therapeutics announced publication of Phase I/IIa clinical trial results of its AT-001 (dnaJP1) compound for treatment of rheumatoid arthritis (RA) in Proceedings of the National Academy of Sciences*. The product, developed at University of California, San Diego, demonstrated biological efficacy, with no significant side effects observed. The AT-001 (dnaJP1) compound is a short, engineered oral peptide with disease-specific immunomodulatory activity. It is a revolutionary biologic that is intended to induce tolerization of the auto immune process in patients with RA, thus inhibiting disease-related inflammation without affecting patient's immunity to infection or cancer.

During the clinical trial, patients with early RA were treated with AT-001 orally for 6 months. The peptide caused no side effects and induced a change from pro inflammatory to regulatory T cell function. Peptide-induced T cell production of IL-4 and IL-10 increased significantly as a result of the treatment, while peptide-induced T cell proliferation and production of IL-2, interferon-gamma and TNF-alpha decreased significantly. Responses to unrelated antigens did not change, confirming the antigen-specific nature of this treatment.

The trial design was open-label and a placebo control was not included. In this open-label context, both physician- and patient-generated clinical scores showed marked improvement from baseline. AT-001 is currently the subject of a multi-center Phase II clinical trial for RA, sponsored by NIH.

Immunomodulation therapy such as AT-001 may be particularly helpful in delaying or possibly abolishing the need for disease modifying antiarthritic drugs (DMARDs), which provide significant improvements in RA, but have potentially serious side effects. Compared to the current generation of anti-inflammatory biologics, AT-001 is intended to have specific and not broadly immunosuppressive action, is oral and has to-date demonstrated a very favorable side-effect profile.

This immunomodulation therapy was developed at University of California, San Diego by Salvatore Albani, M.D., Ph.D., Professor of Medicine and Pediatrics and coworkers. The discovery was supported by previous studies by Dr. Albani and Dr. Dennis Carson, UCSD Professor of Medicine. The University of California has licensed to Androclus Therapeutics exclusive rights to further develop such immunomodulation therapies for RA and other indications. Dr. Albani is the scientific founder of Androclus Therapeutics.

The immunomodulatory approach pioneered by AT-001 is applicable to the treatment of a broad range of auto-immune diseases. Androclus is currently developing therapeutics for the treatment of multiple sclerosis and inflammatory bowel disease, with Phase I/IIa clinical trials expected to start in early 2005.

About Androclus Therapeutics Androclus Therapeutics is a private biotechnology company with a mission to discover, develop and bring to commercial fruition novel products and technologies for treatment of diseases involving the immune system, such as auto-immunity, cancer and infectious diseases. Androclus' revolutionary technology platform enables up- or down-modulation of patients' immune responses, without the broad immunosuppression associated with currently marketed anti-inflammatory drugs. Androclus' R&D portfolio includes oral therapeutic peptides for the treatment of rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease.

For more information, visit Androclus' Web site at www.androclus.com. *Prakken, B.J., R. Samodal, F. Giannoni, G.L. Puga Yung, J.F. Scavulli, A. Amox, S. Roord, I. De Kleer, D. Bonnin, P. Lanza, C. Berry, M. Massa, R. Billetta, and S. Albani. 2004. Epitope-specific immunotherapy induces immune deviation of pro-inflammatory T cells in Rheumatoid Arthritis. Proceedings of the National Academy of Sciences, March 23, 2004, Vol. 101, No. 12, pages 4228-4233.

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