• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » S*BIO to initiate phase III myelofibrosis trial

S*BIO to initiate phase III myelofibrosis trial

October 25, 2011
CenterWatch Staff

S*BIO plans to initiate a global phase III clinical program of its novel JAK2 inhibitor pacritinib (SB1518), in the first half of 2012 to further demonstrate its activity and tolerability for the treatment of myelofibrosis (MF). The company is actively exploring partnering opportunities for the advancement of its leading JAK2 program.

The primary objective of the double-blind, placebo-controlled phase III studies is to compare the efficacy of pacritinib versus placebo in achieving clinically significant reduction in spleen size in MF patients with splenomegaly. Secondary outcomes of both studies include patient-reported change in the most bothersome symptom identified at baseline, duration of response, as well as overall survival. The trials will enroll up to 500 MF patients.

In phase II studies, treatment with pacritinib resulted in sustained reduction in MF-associated splenomegaly with no evidence of myelosuppression and no exacerbation of cytopenias. Pacritinib is a small molecule JAK2-selective kinase inhibitor that demonstrated high potency in preclinical models against both the wild type JAK2 kinase and the JAK2 kinase with the V617F mutation. The V617F mutation is found in high frequency in myeloproliferative disorders such as MF. More than 50% of patients with MF possess the JAK2 mutation.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing