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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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