NEWTOWN, Pa., Jan. 12 /PRNewswire/ -- CollaGenex Pharmaceuticals, Inc.
announced today the results of a new clinical trial designed to evaluate the
efficacy of its lead product, Periostat(R), as an adjunct to scaling and root
planing (SRP), the most prevalent therapy for moderate to severe periodontal
disease and the "gold standard" in currently available treatments for this
disease.
The company also noted that the U.S. Food and Drug Administration, as part
of its ongoing review of the Company's new drug application for Periostat, has
requested a report of the results of these clinical trials to support the
possible use of Periostat as an adjunctive treatment to SRP.
Previous pivotal clinical studies carried out by the Company evaluated the
efficacy of Periostat in conjunction with a typical dental scaling and
prophylaxis. The latest study is the first to establish that Periostat can
significantly enhance the efficacy of SRP. In this study, 190 adult patients
with periodontal disease were administered SRP at the outset of a nine-month,
double-blind placebo-controlled clinical trial at five university dental
centers in the United States. Patients were then randomly assigned to take
either Periostat or a placebo. Measurements of probing pocket depth (PPD) and
clinical attachment level (cALv) were made every three months using a
periodontal probe. Results were compared with measurements taken immediately
prior to the course of SRP.
In the group receiving Periostat, statistically significant improvements
in PPD and cALv (compared with placebo) were seen in all diseased sites as
early as three months following SRP and at all time points thereafter. As
in previous clinical studies conducted by the Company, the more severely
diseased sites improved the most, with PPD and cALv improvements of
approximately 1.7 millimeters and 1.6 millimeters, respectively, at nine
months following SRP in sites with an initial PPD of seven millimeters or
greater.
"These data confirm earlier findings and clearly demonstrate the
incremental clinical value of Periostat as an adjunct to the most commonly
used non-surgical periodontal procedure," noted Brian M. Gallagher, Ph.D.,
President and Chief Executive Officer of CollaGenex. "We are pleased that the
FDA has decided to review these findings now, as this may lead to the drug
being granted this clinically important indication. We believe that this
indication would significantly enhance market adoption of the product
following approval."
CollaGenex Pharmaceuticals is an emerging pharmaceutical company which is
developing and commercializing innovative proprietary medical therapies for
the treatment of periodontal disease and other pathologies. The Company's
core technology involves inhibiting the activity of certain enzymes that
destroy the connective tissues of the body. In addition to periodontal
disease, the Company and its collaborators are researching and developing
other potential applications of the core technology, including cancer
metastasis, wound healing, osteoarthritis, osteoporosis, rheumatoid arthritis
and diabetic nephropathy. Founded in 1992, the company completed an initial
public offering of two million shares of common stock in June 1996.
To receive additional information on CollaGenex, via fax, at no charge,
dial 1-800-PRO-INFO and enter code CGPI.
This news release contains forward-looking statements and therefore it
necessarily involves risks and uncertainties. Factors that could cause actual
events to differ from these forward-looking statements are set forth under the
caption "Risk Factors" in the company's prospectus dated June 20, 1996, which
is part of its registration statement on file with the Securities and Exchange
Commission. There can be no assurance that the company will receive
regulatory approval to market any product or, if such approval is received,
that the product will be commercially successful.
SOURCE CollaGenex Pharmaceuticals, Inc.
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CONTACT: Brian M. Gallagher, Ph.D., President & CEO of CollaGenex, 215-579-7388; or General: Jerry Meyer, Analyst: Brian Gill, or Media: Gil Faggen, of The Financial Relations Board, 212-661-8030
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