NN104 - RHAPSODY

Patrick D. Lyden, MD, Chairman of the Department of Neurology at Cedars-Sinai Medical Center, is the Protocol Principal Investigator of the study "Safety evaluation of 3K3A-APC in ischemic stroke" (NN104). Kent E. Pryor, PhD, Chief Operating Officer of ZZ Biotech, is the Principal Investigator of the X01 NeuroNEXT Infrastructure Resource Access Award. Berislav V. Zlokovic, MD, PhD, Director of the Zilkha Neurogenetic Institute at Keck School of Medicine, University of Southern California, is the Co-Investigator.

Currently, the only approved treatment in the US for ischemic stroke is a drug called recombinant tissue plasminogen activator (rtPA or tPA), indicated for intravenous administration within three hours of onset of the stroke. The drug is designed to break down blood clots to restore blood flow to the brain and thereby prevent further damage. In some patients however, tPA can cause internal bleeding and other complications. 3K3A-APC’s cytoprotective properties may be useful in protecting ischemic brain tissue from further damage, while avoiding an increase in the chance of treatment-related bleeding.

This research study is being conducted to determine the safety, tolerability and activity of 3K3A-APC, following the use of tissue plasminogen activator (tPA) in subjects who have experienced moderately severe acute hemispheric ischemic stroke. The study intervention will be administered as a 15 minute infusion every 12 hours for up to 5 infusions. Four dose levels will be considered for this trial. Approximately 115 participants of age 18-90 years old will be enrolled and followed for 90 days.

The study will be conducted by the NINDS-funded Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) at fifteen sites around the United States:

  • Cedars Sinai, Los Angeles, CA
  • Columbia University, New York City, NY
  • Emory University, Atlanta, GA
  • Massachusetts General Hospital, Boston, MA
  • Northwestern University, Evanston, IL
  • Ohio State University, Columbus, OH
  • SUNY Buffalo, Buffalo, NY
  • University of Cincinnati, Cincinnati, OH
  • University of Kansas, Lawrence, KS
  • University of Pittsburgh, Pittsburgh, PA
  • University of Rochester, Rochester, NY
  • University of Utah, Salt Lake City, UT
  • University of Texas Southwestern, Dallas, TX
  • Univeristy of Virginia, Charlottesville, VA
  • Vanderbilt University, Nashville, TN
  • Washington University, St. Louis, IL

Contact information for all participating sites will be added as personnel are finalized.

Additional announcements:

ZZ Biotech press release

Cedars-Sinai Medical Center press release