(Dentonin) Phase 2 Study Of AC-100 Meets Goal Of Stimulating New Dentin Formation With Favorable Safety Profile In Novel Dental Application
Each year, more than 200 million dental restoration procedures are performed in the United States. Drilling during these procedures irritates the dental pulp and reduces the dentin layer that protects the pulp, causing pain and sensitivity, and sometimes leading to complications, including tooth loss.
"This Phase 2 clinical study demonstrates that a novel biological approach to dentistry, by modulating normal cell functions to stimulate the innate biological defenses of the tooth, can be introduced as a supplement to routine dental care," said Cornelis H. Pameijer, D.M.D., D.Sc., Ph.D., study author and professor emeritus of prosthodontics at the University of Connecticut, School of Dental Medicine. "What is truly exciting are the many possible uses of AC-100 that could cover a broad range of applications in dentistry."
Phase 2 Study Design and Results
The randomized, double-blind, placebo-controlled trial enrolled 35 patients who were candidates for at least two third-molar (wisdom teeth) extractions. Patients served as their own controls, with one molar treated with 200 micrograms AC-100 (applied on days 0, 2 and 4 through the dentin tubules) and the other with a placebo. After two months, the teeth were extracted and evaluated for remaining dentin thickness (RDT), new dentin formation, inflammation and necrosis.
Administration of AC-100 resulted in a clear trend in the formation of new dentin compared to placebo. This effect was seen across a wide variety of cavity depths. Importantly, the efficacy of AC-100 was seen most dramatically in the deepest cavities (RDT < 0.5 mm), where the clinical utility of the approach is most needed. AC-100 was well tolerated in the study with no increase in inflammatory response, necrosis, pulpitis (inflammation of the pulp) or other complications observed in AC-100-treated teeth compared with placebo-treated teeth. No serious adverse events were reported.
"We learned a lot from this trial, and, based on these promising results, plan to meet with the FDA regarding future development as soon as possible," said David M. Rosen, Ph.D., Vice President, Research and Development, at Acologix. "Because of its unique hard tissue regenerating properties and pulp-protective effects, we believe that AC-100 could be a promising treatment for patients undergoing a wide range of dental restoration procedures and could change the way that dentistry is practiced in the future."
In addition to dental applications, Acologix is also 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 scheduled to launch in the United States in the second half of 2006. 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 http://www.acologix.com
Abstract #2225: "AC-100, Novel Biological Approach to Promoting Dentin Formation in Humans," by Mirella Lazarov, D.D.S., Ph.D., David M. Rosen, Ph.D., and Jere D. Fellmann, Ph.D., of Acologix; Pamela DenBesten, D.D.S., M.S., of the University of California, San Francisco, School of Dentistry; and Cornelis Pameijer, D.M.D., D.Sc., Ph.D., of the University of Connecticut, School of Dental Medicine. Presented by Dr. Lazarov on Friday, March 10, at the American Association for Dental Research Annual Meeting in Orlando.
Acologix, Inc.
http://www.acologix.com
(Dentonin) Faza 2 Studiul AC-100 Goal întâlneºte de stimulare a New Dentin Formarea Cu siguranþã favorabile Profil În Novel stomatologice Application - (Dentonin) Phase 2 Study Of AC-100 Meets Goal Of Stimulating New Dentin Formation With Favorable Safety Profile In Novel Dental Application - articole medicale engleza - startsanatate