CollaGenex Pharmaceuticals Announces Results of Phase 2 Dose-Finding Study of Incyclinide for the Treatment of Rosacea.Company to Host Conference Call and Webcast Today at 9:00 a.m. Eastern Time NEWTOWN, Pa. -- CollaGenex Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CGPI CGPI Corporate Goods Price Index (Japan) CGPI Capital Goods Price Index (New Zealand) ) today announced results of a Phase 2 dose-finding study designed to evaluate the safety and determine the therapeutic range of incyclinide for the treatment of rosacea Rosacea Definition Rosacea is a skin disease typically appearing in people during their 30s and 40s. It is marked by redness (erythema) of the face, flushing of the skin, and the presence of hard pimples (papules) or pus-filled pimples (pustules), and . The Company will host a conference call and webcast today at 9:00 a.m. Eastern Time to discuss these results. Additional details about the call are provided below. The primary clinical endpoint In a research trial, a clinical endpoint refers to a disease, symptom, or sign that constitutes one of the target outcomes of the trial. The results of a clinical trial generally indicate the number of people enrolled who reached the pre-determined clinical endpoint during the of the study was a reduction in inflammatory lesions in patients with rosacea. The study demonstrated that incyclinide was well-tolerated, with most adverse events being mild or moderate. However, the patients who were administered incyclinide did not demonstrate a greater reduction in inflammatory lesions than the patients on placebo at any time point during the study. The double-blind, placebo-controlled trial enrolled a total of 197 moderate-to-severe rosacea patients at 19 centers. The patients were divided among four groups and administered either a placebo capsule or a 5 mg, 10 mg or 20 mg incyclinide capsule once a day for 12 weeks. All patients were evaluated by their physicians at weeks 3, 6, 9, 12 and 16. Klaus Theobald, M.D., Ph.D., chief medical officer of CollaGenex, said, "We are surprised and disappointed that the results of this large, well-controlled Phase 2 study did not support the findings of an earlier, much smaller pilot study in rosacea patients. On the basis of these results, we will not be pursuing further clinical development of incyclinide in rosacea patients. However, based on its apparent efficacy in acne patients and its favorable side effect profile in doses up to 20 mg per day, we are planning to conduct additional development work in an acne indication for incyclinide." Colin Stewart The following people are named Colin Stewart
Conference Call Information CollaGenex will hold a conference call today, September 26, 2007, at 9:00 a.m. Eastern Time to discuss the results announced in this release. Investors and other interested parties may access the conference call by dialing 888-868-9079 in the U.S. or 973-935-8510 internationally, or via a live webcast on the company's website at www.collagenex.com. For those who cannot listen to the live webcast, a replay will be available shortly after the call at www.collagenex.com for 90 days. Additionally, a recording of the call will be available by telephone until 11:59 p.m. on October 3, 2007 by dialing 877-519-4471 in the U.S. or 973-341-3080 internationally, and entering access code: 9276919. About CollaGenex CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company currently focused on developing and marketing innovative proprietary 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 also recently completed Phase 2 clinical trials phase 2 clinical trial Phase 2 study. See Phase study. to evaluate COL-118, a topical compound based on the SansRosa(TM) technology, for the treatment of erythema associated with rosacea. CollaGenex's professional dermatology sales force also markets Pandel(R), a prescription topical corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and licensed from Altana, Inc., Alcortin(TM) (1% iodoquinol and 2% hydrocortisone hydrocortisone (hī'drəkôr`tĭzōn'), another name for the steroid hormone cortisol, more especially used to refer to preparations of this hormone used medicinally. ), a prescription topical antifungal steroid combination, and Novacort(TM) (2% hydrocortisone acetate hydrocortisone acetate Cortifoam, Dricort, Micort-HC, Orabase HCA Pharmacologic class: Short-acting corticosteroid Therapeutic class: Anti-inflammatory (steroidal) Pregnancy risk category C 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. Research has shown that new compounds can be created by chemically modifying certain tetracyclines Tetracyclines Definition Tetracyclines are medicines that kill certain infection-causing microorganisms. Purpose Tetracyclines are called "broad-spectrum" antibiotics, because they can be used to treat a wide variety of 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 of these compounds (so called "IMPACS IMPACS Institute for Media, Policy and Civil Society IMPACS Integrated Manufacturing Planning and Control System IMPACS International Message and Packet Switching Service (TM)" compounds because they are Inhibitors of Multiple Proteases And CytokineS Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. ) 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(TM) technology, which consists of a class of compounds that have shown promise in reducing the erythema associated with rosacea, and the Restoraderm(R) technology, a unique, proprietary dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. drug delivery system. In May, 2007 CollaGenex acquired a license from QuatRx Pharmaceutical Company to develop and commercialize becocalcidiol, a patented Vitamin D vitamin D Any of a group of fat-soluble alcohols important in calcium metabolism in animals to form strong bones and teeth and prevent rickets and osteoporosis. It is formed by ultraviolet radiation (sunlight) of sterols (see steroid) present in the skin. analogue currently in Phase II Clinical trials for the topical treatment of mild to moderate psoriasis. 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 relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the clinical results and commercial potential of incyclinide, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 Form 10-Q See 10-Q. for the quarter ended June 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. Oracea (R) and Restoraderm(R) are registered trademarks and IMPACS(TM) and SansRosa(TM) are trademarks of CollaGenex Pharmaceuticals, Inc. Novacort(TM) and Alcortin(TM) are trademarks of Primus Pharmaceuticals, Inc. Pandel(R) is a registered trademark of Taisho Pharmaceuticals. 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. |
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