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Acologix, Inc. Launches First Phase II Clinical Study for AC-100 (Dentonin®) in Dentistry

Hayward, CA – May 4, 2005 — Acologix, Inc., a privately held biopharmaceutical company, announced today the initiation of the first Phase II study using AC-100 (Dentonin®) in dentistry. This study is being conducted under an Investigational New Drug Application (IND) in the United States. There are currently more than 150 million dental restoration procedures performed each year in the United States. Based on activities observed in preclinical studies, it is expected that AC-100 can be used as an adjunct to many common dental procedures.

“The exciting thing about AC-100 is that this drug introduces a natural, biological approach to solving dental problems so unlike the mechanical restorative approach that dominates dentistry today. AC-100 appears to work by stimulating the innate biological defenses of the tooth reducing both postoperative pain and the occurrence of complications after restorative dental procedures, resulting in less pain and more predictable dentistry,” said Dr. Cornelis Pameijer, Professor Emeritus of Prosthodontics at the University of Connecticut, School of Dental Medicine, Farmington, CT.

“This ground-breaking clinical research in a dental application is the first Phase II experience with AC-100. Given the drug’s unique and selective biological profile, we envision that future clinical development for AC-100 will target other major markets such as periodontal defect repair and orthopedics,” said Yoshi Kumagai, President and CEO of Acologix, Inc.

AC-100 is a synthetic peptide derived from an endogenous human protein produced by bone and dental cells. In several preclinical models, AC-100 has demonstrated potent and selective dental tissue and bone formation activity. Acologix completed a Phase I clinical study of AC-100 in healthy volunteers in 2003 — the drug was well tolerated. AC-100 is being developed for dental, periodontal and orthopedic applications.

About Acologix, Inc.

Acologix strives to improve patients’ lives by developing and commercializing innovative biopharmaceuticals targeting “osteo-renal” (bone and kidney) diseases. Acologix’s substantial expertise in the mineral metabolism sciences is the key to solving major osteo-renal health problems. Periodontal disease, general dentistry, oral care, orthopedics, chronic kidney failure, and renal osteodystrophy represent significant underserved medical needs. Acologix is unique in its focus on these rapidly growing health care problems.

This press release contains “forward-looking” statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. Acologix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Acologix’s business.

Company Contact

Yoshi Kumagai
President and CEO
Phone: 510.512.7200
Fax: 510.786.1116

     
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