понедельник, 18 апреля 2011 г.

Acologix Presents Preclinical Data On Cartilage Regeneration By AC-100 At The OARSI 2007 World Congress On Osteoarthritis

Acologix, Inc., a privately
held biopharmaceutical company, announced preclinical study results
demonstrating that AC-100, its novel synthetic peptide derived from an
endogenous human protein produced by bone and dental cells, promoted
cartilage regeneration in an animal model. The data was presented by Dr.
Catherine Middleton-Hardie at the Osteoarthritis Research Society
International (OARSI) 2007 World Congress on Osteoarthritis in Fort
Lauderdale, Florida during the poster sessions.


In this study, goats with an osteochondral femoral condylar (knee
cartilage) defect were used to evaluate the effects of AC-100 on cartilage
regeneration. Cylindrical defects were created in the knee cartilage and
were filled with a collagen sponge containing AC-100 at two different doses
or a collagen sponge soaked in saline (control group). Post-operative
treatments included intra-articular injections of the test articles into
the operated knee joint at weeks one, two and three post surgery. Cartilage
regeneration was evaluated in one group after 84 days and 168 days in
another group.



The results demonstrated that the application of AC-100 dose
dependently promoted cartilage defect repair. The groups treated with the
higher dosage of AC-100 had greater healing outcome scores than the saline
control groups. As there was no evidence of an inflammatory response,
AC-100 demonstrated a favorable safety profile in the study.



These results follow a 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).



"We are very pleased to see this type of response to AC-100 in such a
challenging model. This is the first demonstration of AC-100 to promote
cartilage repair. These findings are consistent with previous studies where
AC-100 has been demonstrated to promote repair of other hard tissues
including bone and dentin," said Dr. David M. Rosen, Ph.D., Senior Vice
President of Research and Development. Additional studies are in progress
to more fully characterize the response and the optimal way to deliver
AC-100 for cartilage repair.



Acologix, Inc.



Acologix, Inc. 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 partnered with Toray Industries, Inc.
of Japan on the development and commercialization of AC-820 (TRK-820) for
the treatment of uremic pruritus in dialysis patients. Acologix is
preparing for a Phase III study with this compound for uremic pruritus in
the United States for 2008. AC-100 (Dentonin(R)), a novel small peptide
with dental, periodontal and orthopedic applications, has been studied in
two Phase II clinical studies; one in dental restoration procedures and
another for the repair of periodontal defects. Further studies to support
development in orthopedic indications are ongoing. Acologix is also
developing AC-200 (Phosphatonin) to treat hyperphosphatemia and subsequent
clinical problems associated with chronic kidney disease. For more
information, go to acologix.



Poster #416: "AC-100 Promotes Articular Surface Restoration and
Subchondral Bone Healing in Osteochondral Defect Study in Goats." by
Catherine Middleton-Hardie, Ph.D., David Rosen, Ph.D., Birthe
Schnegelsberg, Ph.D., Mirella Lazarov, D.D.S, Ph.D., Robert Spiro, Ph.D. of
Acologix, Harold Aberman, D.V.M., Tim Simon, Ph.D. of Applied Biological
Concepts. Presented by Dr. Middleton-Hardie on Friday, December 7 and
Saturday, December 8, 2007, at the Osteoarthritis Research Society
International 2007 World Congress on Osteoarthritis in Fort Lauderdale,
Florida.



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.


Acologix, Inc.

acologix

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