To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Monthly Leuprogel (Leuprolide) Suppresses Serum Testosterone In Advanced Prostate Cancer URL: http://www.pslgroup.com/dg/1ECCB6.htm Doctor's Guide December 5, 2000
FORT COLLINS, CO -- December 5, 2000 -- Atrix Laboratories, Inc. announced results from their Phase III study of Leuprogel™ 1-month, 7.5 mg (leuprolide acetate for subcutaneous depot injection) for the treatment of advanced prostate cancer. In the study, the once-a-month Leuprogel treatment suppressed serum testosterone to therapeutically desired levels with no incidence of testosterone breakthrough during the course of study. Prostate specific antigen (PSA) levels, a common diagnostic measurement of prostate cancer, were also substantially reduced. Early next year, Atrix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) to seek marketing approval. "We are pleased to report that the clinical results of the Phase III study exceeded our expectations," said Dr. Richard Jackson, senior vice president of research and development. "Leuprogel 1-month may have attributes that could provide important additional clinical benefits, particularly the lack of observed testosterone breakthrough during the study period. We are diligently working to prepare and submit the NDA." The Leuprogel 1-month formulation, based on Atrix's proprietary Atrigel® drug delivery system, is injected into the body subcutaneously as a liquid, where it solidifies and releases a predetermined systemic dose of leuprolide continuously as it is bioabsorbed. The sustained levels of leuprolide, a leutinizing hormone-releasing hormone (LHRH) agonist, decrease testosterone levels, which in turn suppress tumor growth in patients with hormone- responsive prostate cancer. Mean testosterone levels for Leuprogel 1-month were below the National Comprehensive Cancer Network recommendations and the FDA's required level for chemical castration. Mean PSA levels were also decreased to low single-digit levels in the study. No serious treatment-related adverse events were recorded over the course of treatment with Leuprogel 1-month. "The results of our Phase III clinical study are exciting and we are moving forward rapidly to apply for FDA approval of Leuprogel 1-month," said David R. Bethune, Atrix's chairman and chief executive officer. "These Leuprogel products provide a significantly larger marketing opportunity than our dentistry products. Completion of this pivotal study of our once-a-month product adds to the attractiveness of our three prostate cancer products and strengthens the Atrix product portfolio." Atrix recently announced the early completion of enrollment for the Leuprogel 3-month 22.5 mg Phase III study. Enrollment for Atrix's Leuprogel 4-month 30mg product is expected to begin early next year. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.