Irvine, CA, Kiel, June 6, 2016 - Proteo, Inc. (OTCQB: PTEO) announced today that its wholly-owned German subsidiary Proteo Biotech AG, a clinical stage pharmaceutical development company, has been awarded a BFEI grant from the German State of Schleswig-Holstein.
The grant has a volume of up to EUR 874,000 (approx. US$ 1 million) and will be used for the R&D program to develop a new formulation of Proteo's lead compound Elafin. Juergen Paal, Chief Operating Officer of Proteo Biotech AG stated: "A new formulation for Elafin will allow us to extend our development pipeline to treat chronic diseases, such as pulmonary arterial hypertension (PAH) with highest possible convenience for the patients." Birge Bargmann, Proteo's Chief Executive Officer commented: "The successful positioning of this innovation in the market will open up a high growth potential for our company and enhance our competitiveness."
Proteo's biopharmaceutical drug candidate Elafin is identical to the human anti-inflammatory protein elafin. It is a potent inactivator of tissue destroying neutrophil elastase and proteinase-3, and was well tolerated in three randomized, double-blind, placebo-controlled clinical trials. Elafin's ability to block tissue destroying proteases makes it a promising drug e.g. for the prevention and treatment of tissue damage in the course of major surgery, pulmonary diseases and organ transplantation.
Proteo is currently setting up a pivotal phase III clinical trial for the prophylactic treatment of acute postoperative complications after resection of esophageal cancer, after a phase II multi-center trial had demonstrated that Elafin treated patients needed a significantly shorter stay in the intensive care unit as compared to placebo patients. In a further phase II study in patients undergoing coronary artery bypass surgery, a significant reduction of the circulating cardiac damage marker Troponin I at 6 hours after surgery was observed.
Pulmonary arterial hypertension ("PAH") is a life-threatening chronic disease in which the pressure in a patient's pulmonary arteries becomes dangerously high. If untreated, patients have a 40% chance of surviving five years, when treated about 60%. Proteo's Elafin blocks the activity of enzymes that are involved in this disease. Our long lasting cooperation partners, the team of researchers lead by Marlene Rabinovitch at Stanford University, have published a new disease modifying principle of Elafin for the treatment of PAH (Nickel et al., Am J Resp Crit Care Med 2015). We believe that this makes Elafin a highly promising compound for the treatment of PAH for which effective drugs with novel therapeutic mechanisms are urgently needed. Proteo has received orphan drug designations for Elafin for PAH in the US and EU.
Proteo is dedicated to the development of new orphan medications in high medical need specialty markets. For its lead investigational drug Elafin, Proteo seeks partners and investors for the development, commercial scale manufacturing, marketing and distribution of the product. Proteo, Inc. common stock is quoted on the OTCQB under the symbol PTEO (www.proteo.us). The company has one wholly owned subsidiary, Proteo Biotech AG, Kiel, Germany (www.proteo.de).
The BFEI grant program of the State of Schleswig-Holstein with focus on the promotion of innovations is a Regional Economic Programme funded by the European Union - European Regional Development Fund (ERDF), the Federal Government and the Land Schleswig-Holstein.
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.
Jürgen Paal, Ph.D.
Proteo Biotech AG
Am Kiel-Kanal 44
Telephone: +49 431 8888-462
Fax: +49 431 8888-463