Kiel, December 18, 2017 - 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-?1 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. The company Proteo Biotech AG is located in 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