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Acologix Presents
Preclinical Data on AC-100’S Novel Mechanism of Action –
Researcher Awarded Young Investigator's Award
HAYWARD, Calif., May 11, 2006 – 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 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 (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 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 AC-820 (or
TRK-820) for the treatment of uremic pruritus in dialysis patients.
AC-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
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 towww.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.
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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