Elafin: Phase II ongoing

Proteo said it has enrolled 75% of the planned 80 patients who are undergoing coronary bypass surgery in the double-blind, placebo-controlled, U.K. Phase II EMPIRE trial evaluating intraoperative Elafin. Proteo also said it received approval of a sub-study in which 10 healthy volunteers will receive an MRI scan, a Feraheme ferumoxytol infusion from and a second MRI scan at 24 hours. The company said the study would aid in the interpretation of MRI scans in patients from EMPIRE. Medical Research Council (MRC) and Chest Heart & Stroke Scotland (CHSS) are providing funding for the trial. The compound is also in Phase II testing to prevent acute organ rejection and chronic graft injury in kidney transplantation patients and to treat inflammation following esophagectomy for esophagus carcinoma.

Minapharm has exclusive rights to develop and commercialize Elafin in Middle Eastern and North African countries under a 2007 deal (see BioCentury, Aug. 13, 2007). Elafin has Orphan Drug designation in the EU to treat esophagus carcinoma, pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension. ...