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Proteo, Inc. / Proteo Biotech AG: FDA grants Orphan Drug Designation to Elafin for 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.
The orphan drug designation was established to encourage development of drugs that support the diagnosis, prevention or treatment of a medical condition affecting fewer than 200,000 people in the U.S. The designation provides U.S. market exclusivity for a seven-year period upon marketing approval for the designated indication and tax credits for clinical research costs. Proteo's CEO Birge Bargmann: "The addition of FDA orphan designation to the existing European orphan designation is an excellent basis for extending the current clinical development program on Elafin for this condition to the United States."
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