h
endometriosis, utilizing a scale proposed by the FDA. The first Phase II
trial will include our selected commercial formulation tablet in two doses,
(150 mg and 250 mg); this trial is actively enrolling approximately 150
patients. The Company expects topline results from the first three months
of treatment in early 2009. The second trial is a four arm comparator trial
of two doses of elagolix, placebo or Leuprolide Depot. This trial is being
conducted in Central and Eastern Europe. Topline data from this 3-month
double-blind trial of approximately 180 patients should be available in the
first half of 2009.
Neurocrine is also investigating the potential of certain GnRH
antagonists in treating other hormone-dependent diseases in Men's and
Women's Health.
Corticotropin Releasing Factor (CRF1) Receptor Antagonists for
Anxiety/Depression and IBS
The CRF collaboration between Neurocrine and GSK has identified
multiple unique high affinity and selective antagonists for the CRF1
receptor that are currently in clinical development for mood disorders and
irritable bowel syndrome (IBS). There are currently three distinct CRF
compounds in clinical development that have arisen out of the GSK
collaboration. The first lead compound (876008) is in a Phase II "proof of
concept" trial to evaluate its safety and efficacy in patients with IBS.
Approximately 130 patients meeting established diagnostic criteria for IBS
have been entered into this cross-over design trial. Standard assessments
of safety, tolerability and pharmacokinetics will be conducted. The
clinical endpoints reflect change in symptom frequency and severity via
validated scales for IBS and the data should be available in the second
half of 2008.
GSK is also advancing the second lead CRF1 receptor antagonist, 561679,
into a Phase II major depression disorder study in the middle of this year.
GSK has also moved a third CRF1 compound, 586529, into a Phase I single
dose escalating clinic
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SOURCE Neurocrine Biosciences, Inc. Copyright©2008 PR Newswire. All rights reserved | |
Page: 1 2 3 4 5 6 7 8 Related medicine technology :1.
Neurocrine Biosciences Reports Fourth Quarter and Year-End 2007 Results2.
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Monogram Biosciences Provides Progenics Pharmaceuticals with HIV Assays for Use in Clinical Trials5.
Sangamo BioSciences and Sigma-Aldrich Announce Publication of Study Demonstrating Zinc Finger Technology for Rapid Generation of Knock-Out Cell Lines6.
Novel PCT Method Unveiled by Pressure BioSciences, Inc. and Collaborators at the Harvard School of Public Health7.
Ardea Biosciences Reports Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating up to 2.0 Log Reduction in Plasma Viral Load8.
Ardea Biosciences Presents Preclinical Data Demonstrating Favorable Resistance Profiles for Non-Nucleoside Reverse Transcriptase Inhibitors for the Treatment of Human Immunodeficiency Virus9.
Sangamo BioSciences Reports 2007 Fourth Quarter and Year-End Financial Results10.
CeloNova BioSciences Introduces a New Class of Coronary Stent: The CATANIA(TM) Coronary Stent System with NanoThin Polyzene(R)-F11.
CeloNova BioSciences Announces Positive Results from European Study of Embozene(TM) Microspheres for Treatment of Uterine Fibroids