| Acologix Announces
Results of
AC-100 Initial Feasibility Study for Treatment of Periodontal Disease
Hayward, Calif., July 24, 2006 – Acologix, Inc., a privately
held biopharmaceutical company, announced today that it has completed
a Phase II feasibility study of AC-100 for the treatment of periodontal
defects. AC-100 is a novel synthetic peptide derived from an endogenous
human protein produced by bone and dental cells.
AC-100 demonstrated a favorable safety profile but did not significantly
regenerate more periodontal bone versus placebo because the dose
evaluated in this study exceeded what researchers believe may be
the optimal dose to effectively treat periodontal disease.
“We learned a lot from this initial Phase II study and believe
additional Phase II studies will determine appropriate dosing of
AC-100 in the periodontal setting,” said David M. Rosen,
Ph.D., Senior Vice President, Research and Development at Acologix. “This
novel approach clearly warrants further study in this and related
conditions. Periodontal disease affects millions of people worldwide
and causes chronic loss of bone and periodontal ligaments that
support teeth, ultimately resulting in tooth loss.”
The study enrolled 40 patients in need of periodontal surgery
to correct existing periodontal defects. Defects were treated with
a single dose of AC-100 or placebo (saline) delivered in a collagen
sponge, and patients were followed for six months. The trial assessed
the safety of AC-100 and its effect on periodontal bone and other
soft tissue regeneration. The use of a novel and highly sensitive
dental computed tomography (CT) instrument for measuring bone regeneration
parameters also was evaluated and compared with traditional clinical
measurement techniques, which include follow-up periodontal surgery.
“There was a high correlation between the bone regeneration
parameters measured by CT and follow-up surgery suggesting that
we may be able to greatly simplify and expedite future trials by
eliminating the need for a second surgical procedure to assess
bone regeneration,” added Dr. Rosen.
Earlier this year, clinical results of a separate Phase II study
of AC-100 as a biological approach to treating tooth defects (prepared
cavities) were presented at the annual meeting of the International
Association for Dental Research (IADR) in Brisbane, Australia.
That trial met its primary goal of stimulating 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.
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 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
3 pivotal clinical trial, and a Phase III trial is planned in the
United States. AC-100 (Dentonin®), a novel small peptide with
dental, periodontal and orthopedic applications, has been studied
in two recently concluded Phase II clinical studies, one in dental
restoration procedures and another for the repair of periodontal
defects, and further studies are currently planned. 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.
Acologix Contact
Yoshi Kumagai
President and CEO
Phone: 510-512-7200
Fax: 510-786-1116
ir-usa@acologix.com
|