Irvine, CA, Kiel, July 17, 2018 - Proteo, Inc. (OTCQB: PTEO) and its wholly-owned subsidiary Proteo Biotech AG today announced the publication of research results by Alcazar et al. from Stanford University on a new mechanism by which Elafin rescues lung cell survival in the lung of newborn mice subjected to mechanical ventilation.
Neonatal chronic lung disease or bronchopulmonary dysplasia develops in
preterm infants whose lungs are incompletely developed and therefore
require respiratory support after birth. The disease condition is
characterized by incomplete formation of alveoli, associated with lung
cell death and disordered deposition of matrix elastin. Treatment with
Elafin is known to mitigate these adverse pulmonary effects of
mechanical ventilation with oxygen-rich gas in newborn mice.
The study identified a novel pro-survival signal which involves
the epithelial growth factor receptor (EGFR) and the Protein Klf4. This
pro-survival signal is disrupted in the lungs of newborn mice exposed
to mechanical ventilation. Elafin treatment reduced cell death in
ventilated newborn lungs both by suppressing elastase activity and
preserving EGFR-Klf4 signaling. The authors conclude that this could
account for Elafin's benefit in promoting alveologenesis and lung growth
in newborn mice during mechanical ventilation.
These experimental findings coupled with the research group’s
observation of significantly increased elastase levels in preterm
infants with evolving neonatal chronic lung disease, support the notion
that Elafin treatment might be effective in mitigating or preventing
neonatal lung injury caused by mechanical ventilation.
Alcazar MA, Kaschwich M, Ertsey R, Preuss S, Milla C, Mujahid S, Masumi
J, Khan S, Mokres LM, Tian L, Mohr J, Hirani DV, Rabinovitch M, Bland
RD. Elafin treatment rescues EGFR-Klf4 signaling and lung cell survival
in ventilated newborn mice. Am J Respir Cell Mol Biol. 2018.
Proteo's biopharmaceutical drug candidate Elafin promises an excellent
therapeutic benefit risk profile for the use as an anti-inflammatory and
tissue protective 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