Dyax Corp. reported positive initial results from its Phase I/II clinical study to evaluate the use of the recombinant small protein DX-88 in patients undergoing cardiopulmonary bypass (CPB) in the course of coronary artery bypass graft (CABG) surgery. The double blind, placebo controlled, dose ranging study recruited 42 patients who were considered at low risk for peri- and post-operative complications. 31 patients were treated with DX-88 and 11 received placebo. The primary endpoints of the study, the pharmacokinetic (PK) profile of DX-88 and safety, were met. The study demonstrated consistent dose related PK and there were no drug related serious adverse events in any group.

DX-88 also demonstrated a biological effect when the secondary endpoint of blood transfusion requirements was examined. The patients treated with DX-88 had an approximate 50 per cent reduction in total blood transfusion needs, as compared to patients receiving placebo.

"We are pleased to have met our primary endpoints. We did not expect to see the level of biological effect of DX-88 on transfusion needs and are encouraged to observe these positive outcomes, particularly given the small sample size and the type of patients included in this Phase I/II trial. This data serves to support the importance of plasma kallikrein in the transfusion needs associated with CPB," commented Dr Tony Williams, senior vice president for Medical Affairs and Clinical Operations of Dyax Corp.

Dyax's Phase I/II study of DX-88 in CABG was conducted at three centres: Emory University Hospital, Atlanta VA Medical Center, and at Duke University Medical Center. DX-88 was administered in the study as an intravenous infusion, starting at induction of anesthesia and continuing until detachment from the CPB machine.

"Over 500,000 coronary artery bypass procedures are performed each year in the United States. One of the inherent risks is contact activation, where blood interfaces with the CPB unit and can activate the kallikrein system, leading to untoward systemic inflammatory responses. As a potent kallikrein inhibitor, DX-88 appears to be useful in mitigating these systemic responses by reducing transfusion requirements and blood loss," commented Dr Jerrold Levy, professor of Anesthesiology at Emory University School of Medicine. "The safety and consistent PK demonstrated in this early study are encouraging, as is the decrease in transfusion needs loss observed versus placebo. I look forward to continuing to work with Dyax on further exploring DX-88's potential as a safe and effective prophylactic agent for CABG surgeries."

Dyax Corp. is a biopharmaceutical company focused on the discovery, development and commercialization of antibodies, small proteins and peptides as therapeutic products for unmet medical needs, particularly in the areas of inflammation and oncology.