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Acologix Presents Findings From the UREMIC PRURITIS National Registry Study at the 41st Annual Meeting of the American Society of Nephrology

HAYWARD, Calif., Nov. 6 /PRNewswire/ -- Acologix, Inc., a privately held biopharmaceutical company, and principal investigators presented key findings from the first ground breaking uremic pruritis ("Itch") registry study of patients on hemodialysis. A total of four abstracts were accepted by the American Society of Nephrology describing key study outcomes with poster presentations by Drs. Michael Germain and James Tumlin. The Itch National Registry Study, the first-ever longitudinal study of uremic pruritus (UP), was designed to better understand the natural history and negative effects of UP, a severe unrelenting itching that complicates end-stage renal failure. According to large international cross-sectional studies, up to 45% of patients undergoing hemodialysis have moderate to severe UP and the condition is associated with increased mortality. The Itch National Registry Study evaluated itching severity with a visual analogue scale and several health-related quality of life measures. One-hundred three (103) hemodialysis patients from 13 U.S. dialysis units were studied over a 3.5 month period. Aspects of quality of life including emotional distress, social function, and sleep were strikingly and negatively affected by UP. Even relatively small incremental increases in pruritus intensity correlated with decrements in quality of life. The data will be presented on November 06, 2008, 2008 at the 41st ASN (American Society of Nephrology) Annual Meeting in Philadelphia, Pennsylvania.

It has been thought that UP is a consequence of inadequate dialysis or metabolic and hematologic abnormalities associated with end-stage renal failure. This study, however, found that in spite of excellent dialysis adequacy and appropriate management of their metabolic and hematologic abnormalities, 72% of study patients had severe pruritus and it often affected large parts of their body. Itching occurred daily or nearly daily in the majority and was unrelieved for more than one year in most patients despite the fact that many were taking antihistamines and/or using moisturizers and other dermatologic treatments for itching.

"The Itch National Registry Study demonstrates the significant affliction UP represents among hemodialysis patients. The need for a safe and effective treatment is clear," commented Dr. Dawn McGuire, Chief Medical Officer of Acologix. "Data from this study is informing our North American development program for AC-820, an oral, kappa-selective opioid agonist with potent anti-pruritic effects. Among UP patients, Japanese clinical trials have shown significant reduction in itching for up to 52 weeks. In over 1100 patients on hemodialysis, AC-820 has demonstrated a consistently good safety profile. We are enthusiastic about developing AC-820 as a first-in-indication treatment, and have commitment to reducing the daily suffering of dialysis patients."

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



Presented by Michael Germain, M.D. and James Tumlin, M.D.

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,

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Posted: November 2008

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