CollaGenex Pharmaceuticals Initiates Phase 2 Dose-Finding Study of Becocalcidiol for the Treatment of Psoriasis

CollaGenex Pharmaceuticals, Inc. 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 for the treatment of psoriasis



NEWTOWN, PA, USA | January 14, 2008 |
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(TM) 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.

SOURCE: CollaGenex Pharmaceuticals, Inc.

 

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