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Acologix Initiates Clinical Trial of Its Lead Compound
for Osteoporosis
Emeryville, CA-December 20, 2002 Acologix, Inc. ("Acologix"),
an emerging biopharmaceutical company with six therapeutic product
candidates, initiates the Phase I clinical study of its lead compound
Dentonin® (AC-100) to support its primary indication, osteoporosis.
Dentonin® demonstrated significant bone formation activities in
several models and a favorable safety profile in pre-clinical toxicology
studies. The IND was filed in late October leading to the administration
to the first human subjects in December. This first study will address
safety and pharmacokinetics in healthy volunteers. A follow on study
is expected to begin in 2003 where biological activity will be assessed
by monitoring biochemical markers of bone metabolism. Publications
regarding the biological activities of Dentonin® are also expected
from a number of bone and dental research groups in 2003.
"We are very pleased with the development of Dentonin® to date
and the compound's entry into clinical trials is a major step for
Acologix. For patients with osteoporosis, Dentonin® is a revolutionary
new compound that promotes rapid new bone formation, and may be
a major advancement in the treatment of the disease" said Yoshi
Kumagai, President and CEO of Acologix. Mr. Kumagai went on to say
"we have achieved our first IND without any delay from the
original schedule set over a year ago and Dentonin® will enter the
clinic on schedule. Acologix's product development team has proven
itself by carrying forward the development of a compound that represents
a new class of molecules into the clinic. Since Acologix has more
novel compounds in our pipeline, the IND submission of Dentonin®
is a strong vote of confidence about our development capability
and the future of our Company."
Dentonin® is a newly identified, human-derived small peptide that
has demonstrated potent bone and dental tissue formation activities.
Chemically synthesized Dentonin® promotes key bone formation events
including osteoblast differentiation, proliferation, production
of bone matrix, as well as mineralization. The potency of Dentonin®'s
bone formation activities were similar or superior to those of other
well-known bone growth factors including BMP (bone morphogenetic
protein), IGF-1 (insulin-like growth factor-1), and FGF (fibroblast
growth factor). Additionally, Dentonin® has shown significant dental
tissue regeneration activities that have not been demonstrated by
other molecules that stimulate growth of hard tissue.
About Acologix, Inc.
Acologix, Inc. is a biopharmaceutical company focused on developing
and commercializing innovative therapeutics to improve the lives
of patients. Acologix's research approach is focused on the biological
functions of minerals and extracellular matrix molecules in the
body, which will lead to further unique therapeutic product candidates.
Company Contact
Yoshi Kumagai
President & CEO
Phone: 510.379.1073 ext 10
Fax: 510.379.1074
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