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Acologix Presents Preclinical Data on Bone Formation and Maturation Stimulated by AC-100 at the European Orthopedic Research Society Meeting
HAYWARD, Calif., June 8, 2006 – Acologix, Inc., a privately-held
biopharmaceutical company, announced today that two preclinical
studies demonstrated that AC-100, its novel synthetic peptide derived
from an endogenous human protein produced by bone and dental cells,
promoted bone formation and maturation in animal models. The data
was presented as an oral presentation at the 16th Annual Meeting
of the European Orthopedic Research Society in Bologna, Italy.
In a canine tooth extraction model for bone regeneration, extraction
sockets were filled with either collagen sponge containing AC-100
at two different doses, or collagen sponge soaked in saline (control
group).
In a rodent calvarial critical defect model, bone defect sites
were filled with collagen sponge containing AC-100 or collagen sponge
soaked in saline (control group). The rats then received daily injections
of AC-100 at different doses or saline over the surgery site for
six days. In both studies, 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 the newly formed bone as assessed
histologically. In the canine study, the groups treated with both
doses of AC-100 had bone quality scores approximately two and three
times higher than controls, respectively. In the rodent study, AC-100
was evaluated over a broad dose range and exhibited a biphasic dose
response curve, with optimal daily doses in the range of 0.1 –
0.5 mg/day. Furthermore, the degree of inflammation was lower in
the AC-100-treated groups than in the control group, although not
statistically significant.
These results follow a recently reported Phase II 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. AC-100
also demonstrated a favorable safety profile in that study.
“Clinical and preclinical trial results to date have shown
that AC-100 stimulates hard tissue formation – specifically
the formation of new bone in bony defects and at fracture healing
sites, and new dentin in teeth. These data further expand our understanding
of AC-100’s activities,” said David M. Rosen, Ph.D.,
Vice President, Research and Development at Acologix. “This
ability to promote mature bone formation has now been confirmed
in several models”.
Acologix is studying AC-100 for periodontal, oral bone, dental
implant and orthopedic applications. Phase II study results of AC-100
used in periodontal surgery are expected later this year.
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
# # #
Abstract # 06: “AC-100, A Synthetic Fragment of MEPE,
Promotes Bone Formation and Maturation in Rodent and Canine Bone
Regeneration Model,” by David M. Rosen, Ph.D. Catherine Middleton-Hardie,
Ph.D., , Mirella Lazarov, D.D.S., Ph.D., Shakun Aswani of Acologix.
Presented by Dr. Rosen at 10:20AM on Thursday, June 8, 2006, at
the 16th Annual Meeting of the European Orthopedic Research Society
in Bologna, Italy.
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’s
business.
Acologix Contact
Yoshi Kumagai
President and CEO
Phone: 510-512-7200
Fax: 510-786-1116
ir-usa@acologix.com
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