About RHAPSODY

At the time of funding for this study, the only approved treatment in the US for ischemic stroke was 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 was 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 was administered as a 15 minute infusion every 12 hours for up to 5 infusions. Four dose levels were considered for this trial. Approximately 115 participants of age 18-90 years old were enrolled and followed for 90 days.