HAYWARD, Calif., May 11 /PRNewswire/ -- Acologix, Inc., a privately-held biopharmaceutical company, announced today that a preclinical study describing the mechanism of action of its novel synthetic peptide, AC-100 was presented at the 33rd annual meeting of the European Calcified Tissue Society (ECTS) in Prague, Czech Republic. AC-100 is a synthetic peptide derived from an endogenous human protein produced primarily by bone and dental cells and has previously been shown to specifically promote new dentin formation in teeth and bone formation at fracture and healing sites with no ectopic calcification. The data were presented by Dr. Catherine Middleton-Hardie of Acologix who was given a Young Investigator’s Award for the submitted abstract.
In part of the study, AC-100 was investigated in a murine (mouse) calvarial organ culture system used to assess effects on bone formation and/or resorption. The results demonstrated that AC-100 dose dependently increased prostaglandin E2 (PGE2) production by up to 5-fold. Doses of AC-100 effective in inducing PGE2 levels correlate with doses that result in optimal bone formation in the same assay system.
In other in vitro and in vivo studies, AC-100 was found to synergize with the bone anabolic factor BMP-2 in promoting osteoblast differentiation in vitro and new bone formation in vivo. Both PGE2 and BMP2 are normally induced at sites of bone injury and the inhibition or lack of cyclooxygenase 2 (COX2), which is required for synthesis of PGE2 is known to dramatically impair fracture healing. Thus, the induction of PGE2 production and the amplification of the osteogenic activity of BMP2 by AC-100 demonstrate an important enhancement of endogenous mechanisms of local repair at sites of bone healing.
These results follow a recently reported Phase 2 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). AC-100 also demonstrated a favorable safety profile in that study.
“We’re very pleased to have the opportunity to present our data on AC-100 at the ECTS meeting, and in particular, having a Young Investigator Award being given to one of our scientists,” said David M. Rosen, Ph.D., Senior Vice President, Research and Development at Acologix. “These data advance our understanding of AC-100 and its use in the regeneration of hard tissues.”
Acologix is studying AC-100 for periodontal, oral bone, dental implant and orthopedic applications. Phase 2 study results of AC-100 used in periodontal surgery are expected later this year.
About Acologix
Acologix, 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 partnering with Toray Industries, Inc. of Japan on the development and commercialization of AC-820 (or TRK-820) for the treatment of uremic pruritus in dialysis patients. AC-820 is being studied in a European Phase 3 pivotal clinical trial, with a Phase 3 trial planned to launch in the United States. AC-100 (Dentonin(R)), a novel small peptide with dental, periodontal and orthopedic applications, is currently being studied in two Phase 2 clinical studies, one in dental restoration procedures and another for the repair of periodontal defects. Acologix is also developing AC-200 (Phosphatonin) to treat hyperphosphatemia and subsequent clinical problems associated with chronic kidney disease. For more information go to www.acologix.com.
Abstract # OC014: “AC-100, A Fragment of MEPE Has a Novel Mechanism of Action, Enhancing Local Production of PGE2 and the Activity of Endogenous Bone Anabolic Agents, Such as BMP2,” by Catherine Middleton-Hardie, Ph.D., David M. Rosen, Ph.D., Mirella Lazarov, D.D.S., Ph.D., of Acologix, Yuuki Imai, M.D., Ph.D., Kunio Takaoka, M.D., Ph.D., of the Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine. Presented by Dr. Middleton-Hardie on Thursday, May 11, 2006, at the 33rd European Symposium on Calcified Tissues in Prague, Czech Republic.
Acologix, Inc.
CONTACT: Keith Lenden, Senior Director of Business Development ofAcologix, Inc., +1-510-512-7214, or keith.lenden@acologix.com
Web site: http://www.acologix.com//
