Proteo announced that the FDA has granted orphan drug designation to Elafin for the prevention of inflammatory complications of transthoracic esophagectomy. Elafin is a copy of a naturally occurring human anti-inflammatory protein, also known as skin-derived antileukoprotease (SKALP).
A Phase 2, double-blind, randomized, placebo-controlled, multi-center clinical trial on patients undergoing transthoracic esophagectomy for the treatment of esophagus carcinoma demonstrated that preoperatively administered Elafin had positive effects on postoperative morbidity and significantly reduced the required period of intensive care – 63% of the Elafin treated patients required only one day of intensive care.
The orphan designation provides U.S. market exclusivity for a seven-year period upon marketing approval for the designated indication.
For more information call (949) 253-4155 or visit www.proteo.us.