Irvine, CA, Kiel, December 18, 2017 - Proteo, Inc. (OTCQB: PTEO) and its wholly-owned subsidiary Proteo Biotech AG today announced the publication of research results by Han et al. from Chongqing Medical University demonstrating that Elafin prevents inflammatory damage to the lung of newborn mice subjected to oxygen-rich gas.
Mechanical ventilation with oxygen-rich gas offers life-saving treatment for newborn infants with respiratory failure, but can also promote lung injury with a considerable risk of chronic lung disease (bronchopulmonary dysplasia) in later life. One reason for this is that lung elastin, a key determinant of lung growth and repair is disordered by mechanical ventilation. A therapeutic agent to prevent ventilator-induced neonatal lung injury would be very helpful for the support of premature infants and improvement of their prognosis.
Han et al. report that Elafin treatment suppressed the inflammatory response associated with aberrant elastin deposition after exposure to oxygen-rich gas and that Elafin treatment improved distal airway development in the injured newborn lung. They conclude that the inhibition of elastase and TGF-β1 signaling observed after Elafin treatment may be a new therapeutic target for preventing oxygen-induced lung injury in neonates.
The results of Han et al. confirm previous results published by Hilgendorff et al., which showed that intratracheal treatment with Elafin protected newborn mice from the adverse pulmonary effects of mechanical ventilation with oxygen-rich gas. Hilgendorff et al. also showed that newborn mice genetically modified to produce Elafin in their lungs were protected against ventilator-induced lung inflammation and the structural damage to their lungs was attenuated.
Source: Han W, Li X, Zhang H, Yu B, Guo C, Deng C. Recombinant human elafin promotes alveologenesis in newborn mice exposed to chronic hyperoxia. Int J Biochem Cell Biol. 2017 (doi: 10.1016/j.biocel.2017.08.004).
Proteo's biopharmaceutical drug candidate Elafin promises an excellent therapeutic benefit risk profile for the use as an anti-inflammatory drug. Elafin is identical to the human protein elafin with high specificity for tissue destroying and inflammation promoting proteases. The development program of Elafin is focused on the late stage development of Elafin in major surgery and early stage development in pulmonary arterial hypertension (PAH). Elafin has received orphan drug designations in the USA and the EU for esophageal cancer surgery (ECS) and PAH. So far, there were no safety concerns after the treatment of 75 patients in three randomized, double-blind, placebo-controlled clinical trials. Postoperative complications in major surgery are the most significant independent risk factor leading to high morbidity and hospital readmissions. Following the completion of two Phase II surgery trials in ECS and coronary artery bypass graft surgery, and a final European Medicines Agency advice letter, a European pivotal trial with Elafin in ECS is in preparation. Treatment of patients undergoing ECS resulted in a significantly shorter intensive care unit stay and a positive postoperative effect on liver and kidney markers. Treatment of patients undergoing coronary artery bypass surgery resulted in a postoperative reduction of the heart damage marker troponin I. In models of PAH it was shown that Elafin reverses obliterative changes in arteries of lung explants from PAH patients and that treatment with Elafin leads to the regression of pulmonary vascular lesions in rats. PAH is still a fatal disease with high medical need for therapies that stop disease progression. A Phase I trial in the US with subcutaneously administered Elafin funded by the NIH is planned to commence with recruitment in 2018.
Proteo focuses on the discovery and development of therapeutic solutions based on its innovative biopharmaceutical Elafin for life threatening surgeries and life threatening diseases such as PAH. 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).
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