• 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 » Enlivex Therapeutics’ positive results from phase I/II bone marrow transplant trial

Enlivex Therapeutics’ positive results from phase I/II bone marrow transplant trial

November 5, 2013
CenterWatch Staff

Enlivex Therapeutics has published a scientific paper in the American Society for Blood and Marrow Transplantation titled “Biology of Blood and Marrow Transplantation.”

The peer-reviewed paper provides additional validation to the phase I/II results and emphasizes the significance of its findings. The findings were based on a 13 patient trial conducted in three clinical centers in Israel.

The patients were given four escalating doses of ApoCell, Enlivex's lead product, shortly before a bone marrow transplant from a foreign donor. No safety concerns were observed in any of the doses and GvHD morbidity levels were significantly reduced.

One of the main concerns in receiving bone marrow transplants from a donor is Graft-versus-Host Disease (GvHD). GvHD is an auto-immune type disease in which the immune system, including the new transplant, attacks organs of the patient, primarily the liver, intestines and skin. The disease can cause significant morbidity and is usually fatal if a patient reaches high grades.

To date, no effective treatment has been found for this disease and up to 70% of transplant recipients suffer from this illness.

ApoCell is based on a cellular treatment developed in Hadassah Ein Kerem by Prof. Dror Mevorach, who has experience in diseases of the immune system. The treatment is based on normal biological activity and initiates a state of “immune tolerance” allowing the implant to fight the patients' cancer while significantly reducing the GvHD severity.

Enlivex Therapeutics recently was awarded Orphan Drug status by the FDA for its ApoCell treatment. The Orphan Drug designation provides for seven years of exclusivity, guaranteeing no competition irrespective of patents and significant regulatory relief, which will likely shorten the marketing approval of the drug in the U.S. and reduce costs.

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