Hi there,

poppin' in every now and then, harldy have time as my employer wants to
go all the way to undo all previous agreements about me working from
home. I have been working from home for 12 hours a week and 8 hours in
the office. That way I can handle the fatigue and still make sure I have
a much needed income.
Anyway, surfing for more news on dna-jpa I came across the site of the
manufacturer ( www.androcolus.com )
and found the following which some of you might find interesting.
I posted on this topic before (last year I think), and then it was all
about RA, apparently they now think it might work for MS and such as well.

Take care

Nikki

San Diego and Milan, Italy – May 14, 2004

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

 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 autoimmune
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 proinflammatory 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 autoimmune 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.

 Androclus Therapeutics inquiries:
 Dr. Igor Bilinsky, COO +1-858-909-0020
 info@androclus.com

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 autoimmunity, 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.

 * 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.

ALSO, SAME SITE:

 AT-001 peptide for the treatment of RA was developed in Prof. Albani’s
laboratory at UCSD and has successfully completed a Phase I/IIa
open-label clinical trial, demonstrating biological efficacy and
evidence of clinical efficacy, with no significant side effects.  Phase
I/IIa results were published in the Proceedings of the National Academy
of Sciences in March 2004.  AT-001 is currently the subject of a
multi-center Phase II clinical trial at UCSD, Stanford, Mayo Clinic,
Johns Hopkins and other centers, to be completed in Q3 2005.  Androclus
has strategically partnered AT-001 with a large biotechnology company.

 Androclus Therapeutics is building on the AT-001 experience to develop
therapeutics for the treatment of MS and IBD.  Pre-IND discussions with
the FDA have been completed regarding the MS compound.  INDs for both MS
and IBD compounds are planned within 1 year.

Product

Stage of development

Indication

Description

AT-001

Phase II

Rheumatoid Arthritis

Oral peptide therapeutic.  Strategically partnered with a large
biotechnology company for RA and psoriatic arthritis indications.  Phase
I/IIa results published in PNAS in March 2004.  Phase II will be
completed in Q3 2005.