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March 07,2006 |
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Kyowa
Releases Results to Phase III Clinical Studies of an Anti-Parkinson’s Disease Drug Istradefylline (KW-6002) Conducted Overseas |
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PRINCETON, NJ, March 7, 2006 -- Kyowa Hakko Kogyo Co., Ltd., located in
Chiyoda-ku, Tokyo, Japan (President: Dr. Yuzuru Matsuda) has completed three
Phase III clinical studies of KW-6002 (generic (INN) name: Istradefylline),
an agent developed in-house for the treatment of Parkinson’s Disease. Parkinson’s Disease is initiated
by a shortage of the neurotransmitter dopamine in the brain, which causes an
imbalance in the nervous system. This
disease is treated mainly by dopamine replacement with L-DOPA. Long-term
therapy with L-DOPA is associated with the development of a shortening
response to each dose. This is called “wearing-off phenomenon.” The
three Phase III clinical studies were conducted in Parkinson’s Disease
patients with “wearing off phenomenon” on treatment with L-DOPA alone or
L-DOPA administered concomitantly with other Parkinson’s Disease medications. Two studies were conducted in North
America and one study was conducted in 14 countries of the EU/and other
regions. In
all three studies, the efficacy and safety of Istradefylline (KW-6002) were
assessed. Istradefylline (KW-6002)
was administered for 12-16 weeks. The
primary endpoint was reduction in the percentage of awake time spent in the
“off” state, and it served as an indicator of the improvement in the “wearing
off phenomenon.” One of the North American studies
revealed a statistically significant reduction in the percentage of awake
time spent in the “off” state. The
other North American study and the trial conducted in the EU/other regions
did not demonstrate a significant reduction in percentage of awake time per
day spent in the “off” state compared with placebo patients, but showed a
significant improvement or a trend toward improvement in one of the secondary
endpoints, the motor function score, assessed using the Unified Parkinson’s
Disease Rating Scale (UPDRS) subscore III.
Istradefylline (KW-6002) showed a similar safety profile as previously
reported in Phase II studies. Based
on these results, together with the results of the Phase IIb program (also
demonstrating a statistically significant reduction in the percentage of
awake time per day spent in the off state), Kyowa Hakko intends to submit a
New Drug Application (NDA) to the United States Food and Drug Administration
(FDA) in the latter half of this year. Istradefylline (KW-6002) has a
specific antagonistic effect on the adenosine A2A receptor in the
brain. This compound is expected to be a novel anti-parkinson’s drug and to
contribute to relieving various symptoms in many patients with Parkinson’s
Disease. Kyowa Hakko Kogyo Co., Ltd. is a
leading life science company headquartered in Tokyo, Japan. Kyowa
Pharmaceutical, Inc. (KPI) is the US development company in Princeton, NJ.
KPI’s current focus is the development of unique agents in CNS, oncology and
urology. #
# # For More Information, Contact: Donna K. Ramer President, StrategCations, Inc. 212.777.5095 (o) 917.744.2669 (m) dramer@strategcations.com |
