CollaGenex Pharmaceuticals Announces Completion of Patient Enrollment for Phase III Clinical Studies of Oracea for the Treatment of Rosacea.NEWTOWN, Pa. -- Company is On Track to Complete Study in the Second Quarter of 2005 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 that it has completed patient screening and enrollment of 528 patients for its two multi-center, double-blinded, placebo-controlled Phase III clinical studies to evaluate the efficacy of Oracea(TM) 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 . CollaGenex anticipates the study to be completed in the second quarter of 2005. The study design provides for sixteen weeks of dosing with either Oracea or placebo and will evaluate the clinical indices of rosacea, including reductions in inflammatory lesions, erythema erythema (ĕr'əthē`mə), more or less diffuse redness of the skin due to concentration of an abnormally large amount of blood within the small vessels of the skin (hyperemia), as in burns. and the Clinician's Global Severity Assessment Score (CGSAS). The two Phase III studies are being conducted at a total of 28 investigational centers across the United States. Colin W. Stewart, president and chief executive officer of CollaGenex, commented, "We are very pleased that we were able to complete enrollment for these two Phase III clinical trials for Oracea ahead of schedule and are on track to complete the study in the second quarter of 2005. Based on the other clinical studies we've done with the same active ingredient in rosacea patients, we anticipate achieving favorable results from these trials in the second quarter of 2005 and remain on track to file an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any for Oracea in the middle of 2005. The completion of patient screening and enrollment is an essential milestone in our plan to become a leading dermatology company." Oracea: An IMPACs Compound Oracea is a once daily, modified-release formulation of doxycycline doxycycline /doxy·cy·cline/ (dok?se-si´klen) a semisynthetic broad-spectrum tetracycline antibiotic, active against a wide range of gram-positive and gram-negative organisms; used also as d. calcium and d. hyclate. , 40 mg, for the treatment of rosacea. Oracea is part of the IMPACS (Inhibitors of Multiple Proteases And CytokineS) family of compounds developed by CollaGenex. These compounds have the potential for multiple therapeutic uses, primarily in the treatment of diseases that cause inflammation and destruction of the connective tissues. The Rosacea Market Rosacea is an increasingly common diagnosis affecting more than 14 million people in the United States. The disease is characterized by inflammatory lesions and the appearance of erythema, a persistent redness of the skin, which usually affects the nose, cheeks and forehead. As rosacea becomes more severe, it is characterized by stinging, burning and/or telangiectasia telangiectasia /tel·an·gi·ec·ta·sia/ (tel-an?je-ek-ta´zhah) permanent dilation of preexisting small blood vessels, creating focal red lesions. , which are tiny spider veins on the nose and cheeks. 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(R), which is indicated as an adjunct to scaling and root planing The objective of scaling and root planing, otherwise known as conventional periodontal therapy, is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,[1] for the treatment of adult periodontitis periodontitis Inflammation of soft tissues around the teeth (see tooth). Poor dental hygiene leads to deposition of bacterial plaque on the teeth below the gum line, irritating and eroding nearby tissues. . 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(R), Atrisorb FreeFlow(R) and Atrisorb-D FreeFlow(R), Atrix Laboratories, Inc.'s products for the treatment of adult periodontitis, to the dental market. The Company's professional dermatology sales force 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. Research has shown that certain unique properties of the 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 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(R) compounds, including Oracea(TM), 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, and Col-3 is in clinical trials to evaluate its potential effectiveness in treating acne and Kaposi's sarcoma, an HIV-related skin condition. In addition, CollaGenex has licensed 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 order 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. Statements in this press release, including statements relating to the litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. with IVAX IVAX Industrial Vax (Dec Computer) and CorePharma, 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' 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 CollaGenex' most recent Annual Report on Form 10-K for the year ended December 31, 2003 and the most recent Form 10-Q for the Quarter ended June 30, 2004 under the sections "Additional Factors That May Affect Future Results" and "Additional Risks That May Affect Results" 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' expectations, beliefs, intentions or strategies 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. Periostat(R) and IMPACS(R) are registered trademarks and Oracea(TM) is a trademark of CollaGenex 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. Pandel(R) is a trademark of Taisho Pharmaceuticals. Atridox(R), Atrisorb(R) and Atrisorb-D(R) are registered trademarks of Atrix Laboratories, Inc. |
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