A bit old, but I'm behind on my reading. Emphasis mine.
Jason
Monday December 4, 6:35 pm Eastern Time
Press Release
SOURCE: Atrix Laboratories, Inc.
Atrix Completes Study on First of Three Prostate
Cancer Products - Begins Preparation of NDA Submission to FDA
FORT COLLINS, Colo., Dec. 4 /PRNewswire/ -- Atrix Laboratories, Inc. (Nasdaq: ATRX - news) announced today
results from their Phase III study of Leuprogel(TM) 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. |
