• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » DNAtrix's DNX-2401 granted E.U. Orphan designation for brain tumors

DNAtrix's DNX-2401 granted E.U. Orphan designation for brain tumors

February 10, 2016
CenterWatch Staff

DNAtrix, a clinical stage, biotechnology company developing virus-driven immunotherapies for cancer, has announced its lead product, DNX-2401, has been designated by the European Commission as an Orphan medicinal product for the treatment of glioma. Glioblastoma, the deadliest form of glioma, strikes approximately 25,000 people a year in the U.S. and E.U.

Sponsors who obtain Orphan designation benefit from a number of incentives, including protocol assistance, scientific advice specific for designated orphan medicines, and market exclusivity once the medicine is on the market.

"We are pleased that the European Commission has recognized the potential benefits of our immunotherapy product for the treatment of brain tumors," said Frank Tufaro, Ph.D., CEO of DNAtrix. "We plan to continue our aggressive development program in the E.U."

DNX-2401 is an oncolytic adenovirus uniquely engineered to be safe and effective for the treatment of gliomas and other cancers. DNX-2401 has been evaluated in over 100 subjects with high grade gliomas in four clinical studies in the U.S. and E.U., with promising results. 

The company recently completed enrollment in a phase Ib clinical study conducted in Spain for recurrent glioblastoma and plans to initiate a study for newly-diagnosed disease in Europe later this year. The company has previously been granted Orphan Drug designation for DNX-2401 in the U.S. for the treatment of glioma.

Upcoming Events

  • 12Apr

    The Patient Playbook Webinar Series, Part 3 — Rethinking the Development of Participant-Centric Clinical Trial Technology

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

  • 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

  • Five Ws

    Consider the Five ‘W’s to Understand Potential Participants

  • QandA-360x240.png

    Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

  • White House

    Trial Stakeholders Advise White House on Emergency Research Infrastructure

  • SurveywBlueBackground-360x240.png

    Stress Levels Continue to Climb in Healthcare Workforce, Survey Finds

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