HAYWARD, Calif., March 6 /PRNewswire/ -- Acologix, Inc., a privately held biopharmaceutical company, today announced the results of its latest preclinical study demonstrating that AC-100, its therapeutic product candidate derived from an endogenous human protein, promotes cartilage regeneration in a large animal model. The data will be presented by Dr. David M. Rosen on March 6, 2010 at the 56th annual meeting of the ORS (Orthopaedic Research Society) in New Orleans, LA.
The effects of AC-100 on cartilage regeneration were evaluated in goats with standardized defects in knee cartilage. Four weekly intra-articular injections of AC-100 or placebo were administered. Quantity and quality of cartilage regeneration were evaluated after six months.
AC-100 dose dependently promoted cartilage repair compared to placebo. Furthermore, the new cartilage formed in response to AC-100 was mature, normal hyaline cartilage as assessed by several histological staining methods. Similar to previous studies, AC-100 exhibited a favorable safety profile in this study, with no inflammatory response.
"These results showing normal cartilage regeneration with AC-100 strongly support our excitement for this program, and we are looking forward to initiating clinical trials in osteoarthritis and traumatic cartilage injury," said Dr. Dawn McGuire, Chief Medical Officer of Acologix. "The previously demonstrated ability of AC-100 to promote regeneration of underlying damaged bone makes the use of AC-100 a unique approach for repair and regeneration of hard tissue in OA, RA, and traumatic injury."
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 is at the Phase 3 stage in the U.S. and was approved for sale in Japan in January of 2009 for the treatment of uremic pruritus in dialysis patients. The second program, AC-100, a 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 that AC-100 also selectively promotes bone and cartilage repair and regeneration. Acologix is also developing AC-200 (Phosphatonin) to treat bone loss associated with chronic kidney disease. For more information, go to www.acologix.com.
Abstract Number 974 "AC-100 Promotes Cartilage Defect Repair in Vivo and Chondrocyte Differentiation and Function in Vitro" by Catherine Middleton-Hardie, Ph.D. and David Rosen, Ph.D. of Acologix, Harold Aberman, D.V.M., Tim Simon, Ph.D. of Applied Biological Concepts, and Tamara Alliston, Ph.D. and Ashton Mortazavi, Ph.D. from the Department of Orthopedic Surgery, University of California, San Francisco. Presented as Poster #974 by Dr. David Rosen on Saturday, March 6, 2010, at the 56th Annual Meeting of the Orthopedic Research Society in New Orleans, LA.
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.
SOURCE Acologix, Inc.
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The effects of AC-100 on cartilage regeneration were evaluated in goats with standardized defects in knee cartilage. Four weekly intra-articular injections of AC-100 or placebo were administered. Quantity and quality of cartilage regeneration were evaluated after six months.
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AC-100 dose dependently promoted cartilage repair compared to placebo. Furthermore, the new cartilage formed in response to AC-100 was mature, normal hyaline cartilage as assessed by several histological staining methods. Similar to previous studies, AC-100 exhibited a favorable safety profile in this study, with no inflammatory response.
"These results showing normal cartilage regeneration with AC-100 strongly support our excitement for this program, and we are looking forward to initiating clinical trials in osteoarthritis and traumatic cartilage injury," said Dr. Dawn McGuire, Chief Medical Officer of Acologix. "The previously demonstrated ability of AC-100 to promote regeneration of underlying damaged bone makes the use of AC-100 a unique approach for repair and regeneration of hard tissue in OA, RA, and traumatic injury."
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 is at the Phase 3 stage in the U.S. and was approved for sale in Japan in January of 2009 for the treatment of uremic pruritus in dialysis patients. The second program, AC-100, a 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 that AC-100 also selectively promotes bone and cartilage repair and regeneration. Acologix is also developing AC-200 (Phosphatonin) to treat bone loss associated with chronic kidney disease. For more information, go to www.acologix.com.
Abstract Number 974 "AC-100 Promotes Cartilage Defect Repair in Vivo and Chondrocyte Differentiation and Function in Vitro" by Catherine Middleton-Hardie, Ph.D. and David Rosen, Ph.D. of Acologix, Harold Aberman, D.V.M., Tim Simon, Ph.D. of Applied Biological Concepts, and Tamara Alliston, Ph.D. and Ashton Mortazavi, Ph.D. from the Department of Orthopedic Surgery, University of California, San Francisco. Presented as Poster #974 by Dr. David Rosen on Saturday, March 6, 2010, at the 56th Annual Meeting of the Orthopedic Research Society in New Orleans, LA.
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.
SOURCE Acologix, Inc.
