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Acologix Completes Phase I Clinical Trial of Lead
Compound Dentonin®
Emeryville, CA-April 30, 2003 Acologix, Inc. ("Acologix"),
a biopharmaceutical company with six therapeutic product candidates,
successfully completed the first- in- human Phase I clinical study
assessing the safety of its lead compound Dentonin® (AC-100) to support
indications in osteoporosis and local bone treatment.
In this placebo-controlled, single-dose study, 29 total subjects
were exposed to Dentonin® dosages of either 50, 100, 200, 400, or
800 mg, given by subcutaneous injection. Each dose was shown to
be safe before subjects were administered the next higher dose.
The subjects were split evenly between men and postmenopausal women.
No drug-related safety issues were observed and all side effects
were minor. Dentonin® was well-absorbed into circulation and blood
levels were linearly proportional to the administered dose. There
were no gender differences observed in the study.
Yoshi Kumagai, President and CEO of Acologix said "we are
pleased with the very positive data from the Phase I clinical trial
which evaluated the safety of Dentonin® and supports its use either
systemically or locally. These data supports multiple indications
which will be developed by Acologix and its licensing partners.
Based on the encouraging safety results from this trial, Acologix
plans to start a 2-week Phase I(b)/Phase II(a) trial shortly in
healthy postmenopausal women with low bone mass to study multiple
dosing and to provide an initial indication of clinical proof of
concept in humans for the treatment of osteoporosis."
Dentonin® is a newly identified, human-derived small peptide that
has demonstrated potent anabolic bone and dental tissue formation
activities during in vitro laboratory tests and animal studies.
Chemically synthesized Dentonin® promotes key bone formation events
including osteoblast differentiation, proliferation, production
of bone matrix, as well as mineralization.
About Acologix, Inc.
Acologix, Inc. is a biopharmaceutical company focused on developing
and commercializing novel therapeutics primarily for the treatment
of metabolic disorders. Acologix's research approach is centered
on the biological functions of minerals and extracellular matrix
molecules in the body, which has led to six unique therapeutic product
candidates.
Company Contact
Yoshi Kumagai
President & CEO
Phone: 510.379.1073 ext 10
Fax: 510.379.1074
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