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Acologix, Inc. Presents Preclinical Data on Cartilage Regeneration by AC-100 at the 30th ASBMR Annual Meeting


9/12/2008 7:57:59 AM

HAYWARD, Calif., Sept. 12 /PRNewswire/ -- Acologix, Inc., a privately held biopharmaceutical company, today announced the results of two preclinical studies demonstrating that AC-100, its therapeutic product candidate derived from an endogenous human protein produced by bone and dental cells, promotes cartilage regeneration in large animal models. The data will be presented by Dr. Catherine A. Middleton-Hardie on September 13, 2008 at the 30th ASBMR (American Society for Bone and Mineral Research) Annual Meeting in Montreal, Canada.

The effects of AC-100 on cartilage regeneration were evaluated in goats with standardized medial femoral condylar (knee cartilage) defects. In one study, deep defects in knee cartilage and underlying bone were treated with a collagen sponge containing AC-100 or placebo followed by three weekly intra-articular injections of the test articles into the operated knee joint. Cartilage regeneration was evaluated after three and six months. In another study, a more superficial knee cartilage defect that did not reach the bone was treated with four weekly intra-articular injections of AC-100 or placebo. In half of the goats in each group, microfracture surgery, used clinically to promote healing, was performed. Cartilage was evaluated after 6 weeks to investigate early regeneration.

In both studies, AC-100 dose dependently promoted cartilage repair compared to placebo. AC-100 treatment increased cartilage regeneration both with and without microfracture. AC-100 demonstrated a favorable safety profile in the study, with no inflammatory response.

These results suggest that repair of both severe and non-severe knee cartilage defects may be improved with intra-articular AC-100, with or without concomitant microfracture procedures.

"Results thus far for cartilage regeneration in experimental injury models, as well as the excellent safety profile of AC-100, provide strong support for initiating clinical development of AC-100 in osteoarthritis and traumatic cartilage injury," said Dr. Dawn McGuire, Chief Medical Officer of Acologix. "AC-100 is unique as a medical treatment potentially promoting regeneration of injured cartilage and underlying bone, as well as providing meaningful symptomatic relief."

Acologix, Inc.

Acologix, Inc. a privately held biopharmaceutical company, is developing and commercializing novel biopharmaceuticals targeting osteo-renal indications, including the complications with chronic kidney disease and dialysis, bone and cartilage repair and regeneration, and general dental and oral care. The company's most advanced program, AC-820 (TRK-820) is in Phase 3 and registration stages in the U.S. and Japan, respectively for the treatment of uremic pruritus in dialysis patients. The second program, AC-100, a new class of hard tissue growth promoting molecule, has been studied in two Phase II clinical studies and demonstrated high safety profile and selective hard tissue formation activities in dental restoration procedures. Further studies have revealed more evidences that AC-100 selectively promotes bone and cartilage repair and regeneration. Acologix is also developing AC-200 (Phosphatonin) to treat hyperphosphatemia and renal osteodystrophy. For more information, go to http://www.acologix.com.

Abstract Number 193 "AC-100 Promotes Cartilage Repair and Sub-Chondral Bone Healing in Surgically Induced Cartilage Defects." by Catherine Middleton-Hardie, Ph.D., David Rosen, Ph.D., Birthe Schnegelsberg, Ph.D., Robert Spiro, Ph.D. of Acologix, Harold Aberman, D.V.M., Tim Simon, Ph.D. of Applied Biological Concepts. Presented as Poster #SA111 by Dr. Middleton-Hardie on Saturday, September 13, 2008, at the 30th ASBMR Annual Meeting in Montreal, Canada.

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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