Proteo Inc. /Proteo Biotech AG: FDA Grants Orphan Drug Designation to Elafin for Prevention of Inflammatory Complications of Transthoracic Esophagectomy
Published: Mar 21, 2013
IRVINE, Calif. & KIEL, Germany--(BUSINESS WIRE)--Proteo, Inc. (OTCQB: PTEO) and its wholly-owned subsidiary Proteo Biotech AG announced today: The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Elafin for the prevention of inflammatory complications of transthoracic esophagectomy. Transthoracic esophagectomy is a surgical procedure that potentially offers a cure for esophagus cancer if the cancer has not spread beyond the esophagus. This serious operation lasts for several hours and carries the risk of numerous inflammatory complications that generally result in high postoperative morbidity requiring intensive care. Proteo’s Elafin is a copy of a naturally occurring human anti-inflammatory protein. In a multicenter Phase II clinical trial on patients undergoing transthoracic esophagectomy for the treatment of esophagus carcinoma it was demonstrated that preoperatively administered Elafin had positive effects on postoperative morbidity and significantly reduced the required period of intensive care. "Current options for prevention of postoperative morbidity due to inflammatory complications are rather limited and we hope that Elafin may help surgeons to reduce postoperative complications and help the patients to recover earlier", said Proteo`s Medical Director Oliver Wiedow.