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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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