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Acologix, Inc. Presents Preclinical Data on Cartilage Regeneration by AC-100 at the OARSI 2007 World Congress on Osteoarthritis


12/7/2007 7:12:03 AM

HAYWARD, Calif., Dec. 7 /PRNewswire/ -- Acologix, Inc., a privately held biopharmaceutical company, today announced preclinical study results demonstrating that AC-100, its novel synthetic peptide derived from an endogenous human protein produced by bone and dental cells, promoted cartilage regeneration in an animal model. The data was presented by Dr. Catherine Middleton-Hardie at the Osteoarthritis Research Society International (OARSI) 2007 World Congress on Osteoarthritis in Fort Lauderdale, Florida during the poster sessions.

In this study, goats with an osteochondral femoral condylar (knee cartilage) defect were used to evaluate the effects of AC-100 on cartilage regeneration. Cylindrical defects were created in the knee cartilage and were filled with a collagen sponge containing AC-100 at two different doses or a collagen sponge soaked in saline (control group). Post-operative treatments included intra-articular injections of the test articles into the operated knee joint at weeks one, two and three post surgery. Cartilage regeneration was evaluated in one group after 84 days and 168 days in another group.

The results demonstrated that the application of AC-100 dose dependently promoted cartilage defect repair. The groups treated with the higher dosage of AC-100 had greater healing outcome scores than the saline control groups. As there was no evidence of an inflammatory response, AC-100 demonstrated a favorable safety profile in the study.

These results follow a reported Phase II clinical trial that demonstrated AC-100 stimulates the formation of new dentin (the hard tissue of teeth that protects the tooth pulp and supports the outer enamel) when applied directly to tooth defects (prepared cavities).

"We are very pleased to see this type of response to AC-100 in such a challenging model. This is the first demonstration of AC-100 to promote cartilage repair. These findings are consistent with previous studies where AC-100 has been demonstrated to promote repair of other hard tissues including bone and dentin," said Dr. David M. Rosen, Ph.D., Senior Vice President of Research and Development. Additional studies are in progress to more fully characterize the response and the optimal way to deliver AC-100 for cartilage repair.

Acologix, Inc.

Acologix, Inc. a privately held biopharmaceutical company, is developing and commercializing innovative biopharmaceuticals targeting osteo-renal diseases, including chronic kidney disease, renal osteodystrophy, bone repair and regeneration, periodontal disease, general dentistry and oral care. Acologix is partnered with Toray Industries, Inc. of Japan on the development and commercialization of AC-820 (TRK-820) for the treatment of uremic pruritus in dialysis patients. Acologix is preparing for a Phase III study with this compound for uremic pruritus in the United States for 2008. AC-100 (Dentonin(R)), a novel small peptide with dental, periodontal and orthopedic applications, has been studied in two Phase II clinical studies; one in dental restoration procedures and another for the repair of periodontal defects. Further studies to support development in orthopedic indications are ongoing. Acologix is also developing AC-200 (Phosphatonin) to treat hyperphosphatemia and subsequent clinical problems associated with chronic kidney disease. For more information, go to http://www.acologix.com.

Poster #416: "AC-100 Promotes Articular Surface Restoration and Subchondral Bone Healing in Osteochondral Defect Study in Goats." by Catherine Middleton-Hardie, Ph.D., David Rosen, Ph.D., Birthe Schnegelsberg, Ph.D., Mirella Lazarov, D.D.S, Ph.D., Robert Spiro, Ph.D. of Acologix, Harold Aberman, D.V.M., Tim Simon, Ph.D. of Applied Biological Concepts. Presented by Dr. Middleton-Hardie on Friday, December 7 and Saturday, December 8, 2007, at the Osteoarthritis Research Society International 2007 World Congress on Osteoarthritis in Fort Lauderdale, Florida.

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' business.

CONTACT: Yoshi Kumagai, President and CEO of Acologix, Inc.,
+1-510-512-7200, fax, +1-510-786-1116, ir-usa@acologix.com

Web site: http://www.acologix.com/


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