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Related Experiment Videos

Transgenic antithrombin III (Genzyme).

P K Yeung1

  • 1Dalhousie University, Pharmacokinetics and Metabolism Laboratory, School of Pharmacy, Burbridge Building, Halifax, NS B3H-3J5, Canada. Pollen.Yeung@Dal.Ca

Idrugs : the Investigational Drugs Journal
|August 13, 2005
PubMed
Summary
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Transgenic recombinant human antithrombin III (rhAT-III) shows promise as an anticoagulant for cardiac surgery patients. Phase III trials indicate rhAT-III effectively reduces fresh frozen plasma use and maintains normal antithrombin III levels.

Area of Science:

  • Biotechnology
  • Pharmacology
  • Cardiovascular Medicine

Background:

  • Development of transgenic recombinant human antithrombin III (rhAT-III) by ATIII LLC, a Genzyme joint venture.
  • rhAT-III is investigated for thrombosis disorders and as an anticoagulant in cardiac surgery patients undergoing cardiopulmonary bypass (CPB).
  • Licensing agreements and funding milestones shape the development and distribution of rhAT-III.

Purpose of the Study:

  • Evaluate the safety and efficacy of rhAT-III in patients undergoing elective cardiac surgery requiring CPB.
  • Compare rhAT-III to placebo in restoring heparin sensitivity in heparin-resistant patients.
  • Determine if rhAT-III is equivalent to plasma-derived AT-III in restoring heparin sensitivity.

Main Methods:

  • Phase III clinical trials conducted in the US and Europe.

Related Experiment Videos

  • Trials involve patients undergoing elective cardiac surgery requiring CPB.
  • Comparison groups include placebo and plasma-derived AT-III.

    • Main Results:

    • European Phase III trial met primary endpoint: reduction in fresh frozen plasma use.
    • Significant results in secondary endpoints: maintenance of normal AT-III levels and changes in D-dimer and fibrin monomer.
    • Enrollment for US trials completed, aiming for filing by end of 2000.

    Conclusions:

    • rhAT-III demonstrates efficacy as an anticoagulant in specific patient populations.
    • Further trials aim to establish rhAT-III as a viable alternative to plasma-derived AT-III.
    • Successful completion of Phase III trials supports potential regulatory submission.