CollaGenex Pharmaceuticals Initiates Phase 2 Dose-Finding Study of Becocalcidiol for the Treatment of Psoriasis
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CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI) today announced that it
has initiated a Phase 2, double-blinded, placebo- and active-controlled,
dose-finding clinical trial to evaluate the safety and efficacy of its
novel compound, becocalcidiol, for the treatment of psoriasis.
The study will enroll 300 patients with mild to moderate psoriasis at 20
investigational centers across the United States. The placebo- and
active-controlled study will evaluate three concentrations of
becocalcidiol administered once daily versus a vehicle and active
control over a 12-week period.
Klaus Theobald, M.D., Ph.D., chief medical officer of CollaGenex, said, "We
are encouraged by the results from an earlier Phase 2 trial that
demonstrated a dose-response relationship for becocalcidiol in the
treatment of psoriasis. The current trial is designed to further explore
and optimize the treatment regimen.”
Colin Stewart, president and chief executive officer of CollaGenex,
stated, "Our ability to initiate this study
quickly should allow us to complete our Phase II dose-ranging study
later this year. As we continue to focus on advancing our pipeline of
therapeutic dermatology compounds, we are very excited about the
potential of becocalcidiol to be a new, steroid-free, long-term
treatment for psoriasis.”
CollaGenex licensed becocalcidiol, a patented Vitamin D analogue, from
QuatRx Pharmaceuticals in May 2007. Unlike all other Vitamin D-based
treatments for psoriasis, becocalcidiol does not appear to induce
hypercalcemia, a significant dose-limiting toxicity.
According to the National Institutes of Health, approximately 7.5
million Americans have psoriasis, a non-contagious, chronic skin disease
characterized by itching and red, scaly patches of skin. The market for
non-biological treatments of psoriasis is currently estimated at $600
million.
About CollaGenex
CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company
currently focused on developing and marketing proprietary, innovative
medical therapies to the dermatology market. In July 2006, CollaGenex
launched Oracea(R), the first FDA-approved
systemic product for the treatment of rosacea. CollaGenex's professional
dermatology sales force also markets Alcortin(R)
(1% iodoquinol and 2% hydrocortisone), a prescription topical antifungal
steroid combination, and Novacort(R) (2%
hydrocortisone acetate and 1% pramoxine HCl), a prescription topical
steroid and anesthetic. Alcortin and Novacort are marketed by the
Company under a Promotion and Cooperation agreement with Primus
Pharmaceuticals, Inc. CollaGenex recently completed a Phase II clinical
trial to evaluate COL-118, a topical compound based on the SansRosa(R)
technology, for the treatment of redness associated with rosacea and
other skin disorders. CollaGenex recently acquired the rights to develop
and commercialize becocalcidiol, a patented Vitamin D analogue developed
by QuatRx Pharmaceuticals Company that is currently in Phase II clinical
trials for the topical treatment of mild to moderate psoriasis.
Research has shown that compounds can be created by chemically modifying
certain tetracyclines and that these new compounds have properties that
may make them effective in treating diseases involving inflammation
and/or destruction of the body's connective tissues. CollaGenex is
evaluating various chemically modified tetracyclines (so called "IMPACS"(TM)
compounds because they are Inhibitors of Multiple Proteases And
CytokineS) to assess whether they are safe and effective in these
applications. The Company has a pipeline of innovative product
candidates with possible applications in dermatology and other disease
states. In addition, CollaGenex has acquired the SansRosa(R)
technology, which consists of a class of compounds that have shown
promise in reducing the redness associated with rosacea, and the
Restoraderm(R) technology, a unique,
proprietary dermal drug delivery system. CollaGenex plans to leverage
these platforms to develop a range of topical dermatological products
with enhanced pharmacologic and cosmetic properties.
To receive additional information on the Company, please visit our Web
site at www.collagenex.com,
which does not form part of this press release.
Forward Looking Statements
Statements in this press release regarding management’s
future expectations, beliefs, intentions, goals, strategies, plans or
prospects, including statements relating to the clinical results and
commercial potential of Oracea, may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. CollaGenex's actual results could differ materially
from those stated or implied in forward-looking statements due to a
number of factors, including those factors contained in the most recent
Form 10-Q for the quarter ended September 30, 2007 under the section
"Risk Factors" as well as other documents that may be filed by
CollaGenex from time to time with the Securities and Exchange
Commission. Forward-looking statements include statements regarding
CollaGenex's expectations, beliefs, intentions, goals, strategies, plans
or prospects regarding the future and can be identified by
forward-looking words such as "anticipate", "believe", "could",
"estimate", "expect", "intend", "may", "should", "will", and "would" or
similar words. CollaGenex assumes no obligations to update the
information included in this press release or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.
Restoraderm(R), SansRosa (R)
and Oracea(R) are registered trademarks
and IMPACS™ is a trademark of CollaGenex
Pharmaceuticals, Inc. Novacort(R) and Alcortin(R)
are trademarks of Primus Pharmaceuticals, Inc. All other trade names, trademarks or service marks are the property
of their respective owners and are not the property of CollaGenex
Pharmaceuticals, Inc. or any of our subsidiaries.