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Acologix’s AC-100 (Dentonin®) Phase II Data on Dentin Formation in Humans Presented at the Annual Meeting of the International Association for Dental Research
HAYWARD, Calif., June 29, 2006 – Acologix, Inc., a privately-held
biopharmaceutical company, announced today that the Company presented
Phase II clinical study data of AC-100, its novel synthetic peptide
derived from an endogenous human protein produced by bone and dental
cells. The data demonstrated that AC-100 stimulated the formation
of new dentin (the hard tissue of teeth that protects the tooth
pulp and supports the outer enamel) when applied to tooth defects.
The data was presented as an oral presentation at the Annual Meeting
of the International Association for Dental Research (IADR) in
Brisbane, Australia. This was a more complete presentation of the
study results following a short presentation on the study made
at the Late Breaking session of the American Association for Dental
Research Annual Meeting in March 2006.
Each year, more than 160 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.
Phase II 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 µg 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.
In addition, preclinical data on dentin and bone regeneration
was presented as a poster presentation at the IADR. In this study,
an indirect pulp capping and a tooth extraction model in animals
were used to evaluate the effects of AC-100 on new dentin and bone
formation, tissue healing and bone quality, respectively.
In the indirect pulp capping portion of this study AC-100 induced
new dentin growth comparable to and better than Dycal in a dose
and application method dependent manner. Importantly, AC-100 achieved
its activity in a tissue protective manner, stimulating the existing
pulp cells to produce dentin while completely abolishing pulp inflammation
and decreasing the number of apoptotic cells in the pulp. This
reduction in pulp irritation responses gives an indication of possible
favorable effects of AC-100 on short-term postoperative tooth sensitivity
due to pulp irritation.
In the bone regeneration portion of the study following extraction,
tooth sockets were filled with a collagen sponge containing AC-100
at two different doses or a collagen sponge soaked in saline (control
group). New bone formation and bone quality were evaluated 28 days
later. Application of AC-100 resulted in a significant and dose-dependent
improvement in the quality of new bone formed. The groups treated
with AC-100 at the two different doses had bone quality scores
approximately two and three times higher than controls, respectively.
Giving an indication of a favorable safety profile, the degree
of inflammation was lower in the AC-100-treated groups than in
the control group, although not statistically significant.
Acologix is studying AC-100 for a variety of hard tissue applications
including periodontal, oral bone, dental implant and orthopedic
applications.
About Acologix, Inc.
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 TRK-820 for
the treatment of uremic pruritus in dialysis patients. TRK-820
is being studied in a European Phase III pivotal clinical trial,
with a Phase III trial planned to launch in the United States. AC-100
(Dentonin®), a novel small peptide with dental, periodontal
and orthopedic applications, is currently being studied in two
Phase II 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.
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.
Abstract # 0545: “AC-100, Novel Biological
Approach to Promoting Dentin Formations in Humans,” by Mirella
Lazarov, D.D.S., Ph.D., Jere D. Fellmann, Ph.D., and David M. Rosen,
Ph.D. of Acologix; Pamela DenBesten, D.D.S., M.S., of 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 June 29,
2006 at the Annual Meeting of the International Association for
Dental Research in Brisbane, Australia
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Abstract #0268: “AC-100, A Novel Biological Agent for Dentin
and Bone Regeneration,” by Mirella Lazarov, D.D.S., Ph.D.,
David M. Rosen, Ph.D. of Acologix; Mei-Shu Shih, Ph.D., A. Negron
of SkeleTech; and Veronica Kiklevich, D.V.M., Michael Powers, D.V.M.,
of the Department of Veterinary Clinical Sciences, Washington State
University. Poster presented on June 28, 2006 at the Annual Meeting
of the International Association for Dental Research Brisbane,
Australia.
Acologix Contact
Yoshi Kumagai
President and CEO
Phone: 510-512-7200
Fax: 510-786-1116
ir-usa@acologix.com
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