Kiel, July 17, 2018 - 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.
Source: Alejandre 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. The company Proteo Biotech AG is located in Kiel, Germany (www.proteo.de).
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Jürgen Paal, Ph.D.
Proteo Biotech AG
Am Kiel-Kanal 44
Telephone: +49 431 8888-462
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