Optro recombinant hemoglobin data
Two early Phase II trials with Optro recombinant hemoglobin in surgical patients showed no clinically significant adverse effects during or after treatment. Based on the results, partner Eli Lilly plans to begin an expanded multicenter late Phase II trial in the near future for the treatment of intraoperative blood loss.
The first trial focused on intraoperative use of Optro to restore blood volume and oxygen delivery during surgery. Of 23 patients undergoing elective surgery, 16 received 25-100 g of Optro to replace up to four units of blood, and 7 patients received standard transfusion therapy. Some patients in the treatment group experienced elevated levels of amylase and lipase beginning 12-24 hours post-infusion, which returned to normal in most cases 48 hours after dosing. No clinical signs of pancreatitis were observed. ...