CollaGenex Pharmaceuticals Initiates 40 mg Cohort in the Phase II Dose-Finding Study of Incyclinide for the Treatment of Acne.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 that it has initiated enrollment in a 40 mg cohort in its Phase II double-blinded, placebo-controlled, dose-finding clinical trial to determine the appropriate dose for Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA testing of incyclinide in the treatment of acne. The 40 mg cohort will enroll 100 patients with moderate-to-severe acne at 13 investigational centers across the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . The placebo-controlled study will evaluate a daily 40 mg dose of incyclinide over a 12 week period. Klaus Theobald, M.D., Ph.D., chief medical officer of CollaGenex, said, "We are extremely encouraged that the analysis of the 5, 10, and 20 mg cohorts demonstrated a dose-response relationship for incyclinide in the treatment of acne. We established a minimum effective dose at 10 mg per day and saw greater efficacy at the 20 mg daily dose. Incyclinide appears to be safe and effective at a 20 mg daily dose with a side effect profile similar to placebo. Since we do not believe that we have yet seen peak efficacy, we are continuing the study with a 40 mg cohort." Colin Stewart, president and chief executive officer of CollaGenex, stated, "Our ability to initiate the 40 mg cohort quickly should allow us to complete our Phase II dose-ranging study later this year and initiate Phase III clinical trials of incyclinide in acne patients in the first quarter of 2008. We continue to be very excited about the potential of incyclinide to be the first new compound approved to treat acne in over 20 years." 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(TM), the first FDA-approved systemic product 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 is also conducting Phase I clinical trials to evaluate COL-118, a topical compound based on the SansRosa(TM) technology, for the treatment of redness associated with rosacea and other skin disorders. 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 several 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 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, and plans 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 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-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the quarter ended December 31, 2006 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) is a registered trademark and IMPACS(TM), SansRosa(TM) and Oracea(TM) are trademarks of CollaGenex Pharmaceuticals, Inc. MetroGel(R) is a registered trademark of Galderma Laboratories, 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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