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.
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."
The company researches, develops and markets compounds for biological and medical research as well as for use as pharmaceuticals. The main focus is on anti-inflammatory drugs, in particular on the human protease inhibitor Elafin. Proteo intends to out-license selected indications and to establish international strategic alliances in order to open up new fields of application and for marketing (www.proteo.us).
Certain statements in this news release may contain forward-looking information within the meaning of Rule 175 under the Securities Act of 1933 and Rule 3b-6 under the Securities Exchange Act of 1934, and are subject to the safe harbor created by those rules. All statements, other than statements of fact included in this release, including, without limitation, statements regarding potential future plans and objectives of the company, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Technical complications that may arise could prevent the prompt implementation of any strategically significant plan(s) outlined above. The company cautions that these forward looking statements and risks and uncertainties involved are further qualified by other factors including, but not limited to those set forth in the company’s Form 10-K filing and other filings with the United States Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any statements in this release, whether as a result of new information, future events or otherwise.