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On 14 Jan 2001, at 9:58, Edie Luther. wrote:

> Does anyone know if this is the first human study?         Edie

Hi Edie,
While Madden in Ohio, CNI in Colorado, BUMC in Boston, and Bethsada, Maryland
are now recruiting,  I believe this is not the first human study... M. Paul Bedard has
been studying this drug in Quebec since 1998.

In fact it appears the research in this area extends back to 1929....
For a detailed and very technical article see...

Purinergic Mechanisms in Nervous System Function and Disease States
Michael F. Jarvis and Michael Williams
Introduction The role of the purine nucleoside, adenosine and its nucleotides,
AMP, ADP and ATP, in intercellular signaling processes originated with the
report of Drury and Szent-Gyorgi in 1929  <SNIP>
http://www.acnp.org/G4/GN401000063/CH.HTML

There are ongoing Phase II Clinical Studies in the U.S.;the U.K.; & Japan...

I believe the terms Phase II Clinical Study indicate a Phase I study involving animals
has already taken place... Would someone please set me right if this is an incorrect
assumption?

I got the following info off a Japanese web site...

July 11, 2000
KW-6002
Phase II clinical study in depression was started in the U.S.

Kyowa Hakko Kogyo Co., Ltd. (President: Dr. Tadashi Hirata) started in June 2000
phase II clinical study in depression for KW-6002 in the U.S.

KW-6002 is now under development as a therapeutic agent for Parkinson's disease.
This product also demonstrated excellent efficacy on several depression models, and
the company decided to carry out exploratory phase II study to investigate the
potential of the product for novel treatment of depression.  Kyowa Pharmaceutical,
Inc., a subsidiary in the U.S., is advancing the clinical development in the U.S.

Most antidepressant drugs are based on the assumption that depression results from
a shortage of neurotransmitters, serotonine or norepinephrine, in the brain.    Thus
tricyclic antidepresssants and selective serotonine reuptake inhibitors (SSRI) which
now dominate the market have been used to treat depression.  KW-6002 is a selective
antagonist of adenosine A2A receptor and can provide a potentially new mechanism
of antidepressant different from that of the conventional drugs.

We live in an age full of depression, anxiety and insomnia, and the patients who suffer
from depression and depressive state are drastically increasing.  The patients with
depression are estimated at more than 20,000,000 in the U.S.  KW-6002 is expected to
make a new contribution to medical care as a novel antidepressant.

http://www.kyowa.co.jp/netext/er000711.htm

*************

This is from R&D Focus Drug News...

KW 6002 Kyowa Hakko phase change II, Japan, UK.
Issue: August 30, 1999
Kyowa Hakko is developing KW 6002 in phase II trials in the USA, Japan and the UK.
This product has potential in the treatment of Parkinson's disease.
KW 6002, N4A, Antiparkinson Drugs, Kyowa Hakko, phase-II, Japan, UK

COPYRIGHT 1999 IMS World Publications Ltd.
COPYRIGHT 2000 Gale Group

http://www.findarticles.com/cf_0/m0FQN/1999_August_30/55584240/p1/article.jhtml

*****************

R&D Focus Drug News
KW 6002 Kyowa Hakko phase change II, USA (depression).
Issue: July 31, 2000
A phase II study of Kyowa Hyakko's KW 6002, evaluating the agent's potential as an
antidepressant, is under way in the USA. The company decided to proceed with
clinical trials after KW 6002 demonstrated efficacy in several animal models of
depression.

This compound is an adenosine A2 antagonist developed as a treatment for
Parkinson's disease. The product is undergoing phase II studies in the USA, UK and
Japan for this indication.

KW 6002, N4A, Antiparkinson Drugs, N6A, Psychoanaleptics,
Antidepressants, Kyowa Hakko, phase-II, USA

COPYRIGHT 2000 IMS World Publications Ltd.
COPYRIGHT 2000 Gale Group

http://www.findarticles.com/m0FQN/2000_July_31/63741410/p1/article.jhtml

I hope this answers your question.

All the best .. murray
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