Message #21 From:
NewsBot Date: January 17, 2007 05:35:00 AM
CGXP News Ceragenix Provides Update on Clinical Study
DENVER--(BUSINESS WIRE)--Ceragenix Pharmaceuticals, Inc. (OTCBB:CGXP), a biopharmaceutical
company focused on infectious disease and dermatology, today reported it
has enrolled the 90th patient for a clinical
study that compares the efficacy of the company’s
EpiCeram™ to Cutivate®
(a mid strength topical steroid) in patients with moderate to severe
atopic dermatitis (eczema).
The multi-center study consists of 90 children between the ages of 6
months and 18 years of age. Over a four-week period, half of the
subjects will receive treatment with EpiCeram, with the other half to
receive treatment with Cutivate. The objective of the study is to
determine if EpiCeram can be as effective as a mid-strength steroid in
treating the symptoms associated with eczema, like itching and
inflammation.
Steven Porter, Ceragenix’s chairman and CEO,
commented, “This marks a significant milestone
towards completing the study. If we can effectively demonstrate EpiCeram
to have comparable efficacy to Cutivate, we believe this new treatment
alternative will be well received by pediatricians and dermatologists.
It will also aid our ongoing efforts to partner with a pharmaceutical
company with experience in marketing dermatology products.”
The company will continue enrollment through the end of January 2007 to
allow for potential dropouts, and then complete patient visits by the
end of February 2007. The results of the study are expected to be
released by the end of March 2007.
About Atopic Dermatitis
According to the National Institute of Arthritis and Musculoskeletal and
Skin Diseases (NIAMS), more than 15 million people in the U.S. have
symptoms of atopic dermatitis. Children are more commonly affected than
adults, with 90 percent of acute dermatitis cases diagnosed by age five.
Roughly 60 percent of infants affected continue to have one or more
symptoms of atopic dermatitis into adulthood.
NIAMS researchers project that U.S. health insurance companies spend
approximately $1 billion per year on atopic dermatitis. It is estimated
that topical steroids account for approximately $345 million of the
atopic dermatitis market. Atopic dermatitis has also been found to
affect patient quality of life due to its uncomfortable symptoms and how
it alters physical appearance.
About Ceragenix
Ceragenix Pharmaceuticals, Inc. is a biopharmaceutical company that
discovers, develops and commercializes novel anti-infective drugs based
on its proprietary class of compounds, Ceragenins™
(or CSAs). Active against a broad range of gram positive and negative
bacteria, these agents are being developed as anti-infective medical
device coatings (Ceracides™) and as
therapeutics for antibiotic-resistant organisms. Ceragenix also owns
exclusive rights to Barrier Repair Technology for the treatment of
dermatological disorders including atopic dermatitis, neonatal skin
disorders and others. Ceragenix's patented Barrier Repair Technology,
invented by Dr. Peter Elias and licensed from the University of
California, is the platform for the development of two prescription
topical creams -- EpiCeram™ and NeoCeram™.
For additional information on Ceragenix, please visit www.ceragenix.com.
FORWARD-LOOKING STATEMENTS
This press release may contain forward-looking statements. The Private
Securities Litigation Reform Act of 1995 provides a safe harbor for
forward-looking statements. These forward-looking statements are subject
to risks and uncertainties that may cause actual results to differ
materially from those expressed or implied by such forward-looking
statements, including, but not limited to, the following: the ability of
the company to raise sufficient capital to finance its planned
activities; receiving the necessary marketing clearance approvals from
the United States Food and Drug Administration; successful clinical
trials of the company's planned products including; the ability to
enroll the studies in a timely manner, patient compliance with the study
protocol, a sufficient number of patients completing the studies; the
ability of the company to commercialize its planned products; the
ability of the company to consummate a favorable marketing agreement
with a partner to market EpiCeram™; market
acceptance of the company's planned products, the company's ability to
successfully develop its licensed compounds, alone or in cooperation
with others, into commercial products, the ability of the company to
successfully prosecute and protect its intellectual property, and the
company's ability to hire, manage and retain qualified personnel. The
aforementioned factors do not represent an all inclusive list. Actual
results, performance or achievements could differ materially from those
contemplated, expressed or implied by the forward-looking statements
contained in this press release. In particular, important factors that
could cause actual results to differ materially from the company's
forward-looking statements include general economic factors, business
strategies, the state of capital markets, regulatory conditions, and
other factors not currently known to the company, may be significant,
now or in the future, and these factors may affect the company to a
greater extent than indicated. All forward-looking statements
attributable to the company or persons acting on its behalf are
expressly qualified in their entirety by the cautionary statements set
forth in this press release and in other documents that the company
files from time to time with the Securities and Exchange Commission
including its Annual Report on Form 10-KSB, Quarterly Reports on Form
10-QSB and Current Reports on Form 8-KSB to be filed in 2007. Except as
required by law, the company does not undertake any obligation to update
any forward-looking statement, whether as a result of new information,
future events or otherwise.
