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Acologix, Inc. AC-200 Demonstrates Positive Effect on Bone in Preclinical Model of Chronic Kidney Disease Data Presented at the 41st Annual Meeting of the American Society of Nephrology



11/7/2008 9:21:34 AM

HAYWARD, Calif., Nov. 7 /PRNewswire-FirstCall/ -- Acologix, Inc., a privately held biopharmaceutical company, will present data indicating that its therapeutic product candidate AC-200 improved bone architecture in a rat model of chronic kidney disease. AC-200, an endogenous human protein produced by bone cells, was evaluated in a well accepted rodent model of chronic kidney disease (CKD) in which bone loss is rapid and substantial. The data will be presented by David Rosen, Ph.D on November 8, 2008 at the 41st ASN (American Society of Nephrology) Annual Meeting in Philadelphia, PA.

The effects of AC-200 on bone and mineral metabolism were evaluated in partially nephrectomized rats (5/6 Nx). These rats have reduced renal function which leads to elevated levels of serum phosphate and parathyroid hormone (PTH). Bone loss is an important feature of the model, similar to renal osteodystrophy seen in CKD patients. Recombinant AC-200 (MEPE: Matrix Extracellular Phosphoglycoprotein) or vehicle control were administered for 14 days by intravenous injections to 5/6 Nx rats. Serum and urine biochemistry assays were performed to determine the effects on renal function and mineral metabolism. Femurs were analyzed by X-ray and histology to determine effects on both cortical and trabecular bone.

AC-200 administration resulted in marked reductions in serum phosphorus and PTH levels compared to those in vehicle treated controls. The vehicle treated 5/6Nx group showed the expected changes in bone architecture due to the loss of kidney function, such as thinner trabecular bone in the metaphysis, increased cortical bone resorption and increased fibrosis in the marrow space. In contrast, in rats administered AC-200, bone architecture resembled that of sham operated controls. These data suggest that AC-200 offers a unique dual benefit in CKD, potentially correcting not only mineral abnormalities but also reducing bone pathology associated with complications such as hip fracture in CKD patients.

"Results of AC-200 administration in this standardized CKD rodent model provide strong support for clinical development of AC-200" said Dr. Dawn McGuire, Chief Medical Officer of Acologix. "AC-200 offers a unique opportunity to address both hyperphosphatemia and pathologic bone loss, major complications of CKD, with a single agent."

Acologix, Inc.

Acologix, Inc. a privately held biopharmaceutical company, is developing and commercializing novel biopharmaceuticals targeting osteo-renal indications, including the complications of 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 evidence 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 www.acologix.com.

Poster Number SA-PO2781: "mAtrix extracellular Phosphoglycoprotein (MEPE) inhibits renal phosphate reabsorption and decreases bone porosity in a 5/6 nephrectomy rat model" by Birthe Schnegelsberg, Ph.D., Shakun P. Aswani, Marybeth George, Catherine Middleton-Hardie, Ph.D., David Rosen, Ph.D., of Acologix, Inc. Data presented by David Rosen, Ph.D on Saturday, November 8, 2008, at the 41st Annual Meeting of the American Society of Nephrology (Renal Week 2008) in Philadelphia, PA.

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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