CollaGenex Pharmaceuticals Reports Positive Outcome of Phase 2 Clinical Study Evaluating COL-3 as a Treatment for Rosacea
NEWTOWN, Pa.--(BUSINESS WIRE)--April 15, 2005--CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI - News) today announced the results of a double-blinded, placebo-controlled Phase 2 clinical study designed to evaluate the safety and efficacy of COL-3 for the treatment of rosacea. Col-3 is a second-generation IMPACs(TM) compound that has demonstrated a range of potent anti-inflammatory activities.
This multi-center study was conducted by Guy Webster, M.D., Thomas Jefferson University, Philadelphia, PA; Robert Skidmore, M.D., Gainesville, FL;, and Anna Duarte, M.D., Children's Skin Center, Miami, FL.
This was a small, Phase 2, proof-of-principle study that enrolled 13 patients who received either COL-3 or placebo for 28 days. Patients were evaluated at baseline and at Days 14, 28 and 42. Inflammatory lesion counts and assessments of erythema (redness) and overall clinical disease severity were obtained at each of these time points. At all time points during the course of the study, patients receiving COL-3 had significantly fewer inflammatory lesions than those on placebo. At Day 42, patients treated with COL-3 experienced a 69% reduction in lesion counts compared to an increase of 12% in the placebo group (p<0.01). A treatment benefit was also apparent in the overall clinical severity score and less pronounced in the assessment of erythema, which trended towards improvement. There were no serious adverse events reported.
"These results are remarkably strong for a preliminary study and I am excited about the drug's potential," remarked Dr. Webster.
"While this was a relatively small study, the magnitude of the drug effect is extraordinary and achieved statistical significance in the most important endpoint, reduction in inflammatory lesions. Compared to other therapies, there was a rapid onset of the treatment benefit, which is very encouraging for patients seeking to quickly resolve the unattractive manifestations of this disease," said Klaus Theobald, M.D., Ph.D., senior vice president and chief medical officer of CollaGenex.
"This is the first placebo-controlled study demonstrating COL-3's efficacy in treating a dermatologic condition," said Colin Stewart, president and chief executive officer of CollaGenex. "Shortly we will initiate a proof-of-principle, Phase 2 clinical study in patients with acne, where current treatment of severe cases is accompanied by a notable side effect risk. If our development of this product continues to be successful, COL-3 will expand our product portfolio beyond our lead product candidate, Oracea, and significantly strengthen CollaGenex' position in the acne and rosacea markets."
About Rosacea
Rosacea is an increasingly common diagnosis affecting nearly 14 million people in the United States. The disease is characterized by inflammatory lesions and the appearance of erythema (a characteristic pattern of persistent redness) that usually affect the nose, cheeks and forehead, and is often combined with small spider veins called telangiectasia near the surface of the skin of the cheeks and nose. As rosacea becomes more severe, itching and pain can occur. It is estimated that patients suffering from rosacea spend in excess of $500 million on prescription medications every year in the United States.
About CollaGenex
CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on providing innovative medical therapies to the dental and dermatology markets. Currently, the Company's professional dental pharmaceutical sales force markets Periostat, which is indicated as an adjunct to scaling and root planing for the treatment of adult periodontitis. Periostat is the first and only pharmaceutical to treat periodontal disease by inhibiting the enzymes that destroy periodontal support tissues and by enhancing bone protein synthesis. The dental sales force also promotes Atridox®, Atrisorb FreeFlow® and Atrisorb-D FreeFlow®, which are products of QTL, Inc., the successor to Atrix Laboratories, Inc., for the treatment of adult periodontitis. The Company's professional dermatology sales force markets Pandel®, a prescription topical corticosteroid licensed from Altana, Inc.
Research has shown that certain unique properties of the tetracyclines discovered during the development of Periostat may be applicable to other diseases involving inflammation and/or destruction of the body's connective tissues. CollaGenex is further evaluating Periostat and other IMPACS compounds, including Oracea and COL-3, to assess whether they are safe and effective in these other applications. Oracea is currently in Phase III clinical trials to evaluate its effectiveness in treating rosacea, a dermatological condition. In addition, CollaGenex has acquired the Restoraderm® technology, a unique, proprietary dermal drug delivery system, and plans to develop a range of topical dermatological products with enhanced pharmacologic and cosmetic properties.
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