• 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 » FDA approves Bionomics’ phase I/II ovarian cancer trial

FDA approves Bionomics’ phase I/II ovarian cancer trial

March 26, 2012
CenterWatch Staff

Bionomics Limited, an international biotech based in Thebarton, Australia, has gained approval from the FDA to proceed with its clinical trial of BNC105 in women with ovarian cancer.

Bionomics anticipated the approval and has already prepared much of the trial, with expected initiation in the next quarter. The phase I/II trial will evaluate BNC105 in combination with carboplatin and gemcitabine in a multi-centre trial in Australia and the U.S.

BNC105 is a Vascular Disruption Agent (VDA) that rapidly shuts down existing and new tumor blood vessels with no effect on normal blood vessels. Preclinical data has indicated that all solid tumor types, including breast, prostate and lung cancers, are susceptible to the VDA effect of BNC105 and that the compound also potently inhibits the growth of a broad range of cancer cells in culture.

In addition, BNC105 is currently under evaluation in combination with the mTOR inhibitor Everolimus (Afinitor), in a U.S. multi-center phase II clinical trial in patients with metastatic renal cell carcinoma (kidney cancer). More than 21 U.S.-based trial sites have been activated to date and the combination of BNC105 and Afinitor has been shown to be safe and well tolerated. Enrollment in the trial is due for completion at the end of 2012.

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