Proteo, Inc. / Proteo Biotech AG: Elafin Combined with Cyclosporine Promises to Overcome Limitations of Cyclosporine for Preventing Irreversible Damage to Transplanted Organs.

IRVINE, Calif & KIEL, Germany--(BUSINESS WIRE)--

Proteo, Inc. PTEO and its wholly-owned subsidiary Proteo Biotech AG today announced the publication of new results from a group of researchers lead by Mark Nicolls at the Stanford School of Medicine which demonstrate that Elafin and cyclosporine A act synergistically to prevent the development of irreversible damage to transplanted lung tissue in an animal model.

The survival of solid organ transplant recipients has dramatically improved since the introduction of cyclosporine A, a drug which suppresses the activity of T cells in the adaptive immune system. It is well known that in addition neutrophils, the dominant cell population of the innate immune system, are associated with injury to transplanted lungs. The objective of the study in a mouse tracheal transplant model was to determine whether simultaneous suppression of the innate and adaptive immune responses by a combination of the elastase inhibitor Elafin and cyclosporine A would lead to better preservation of airway microvasculature and architecture than targeting T cell activity alone.

In this study, a marked positive synergistic effect on graft oxygenation was observed using a combination of Elafin and cyclosporine A. This is explained by the prevention of cyclosporine A induced tissue damage and in addition by the complementary inhibitory effects of both drugs on the innate and the adaptive immune responses. The authors explain that Elafin may achieve its therapeutic effects by reducing inflammation, reducing the production of reactive oxygen species and endothelial cell complement deposition, or by acting as an endothelial cell mitogen to directly promote angiogenesis.

The researchers state: "Our study suggests that the suppression of neutrophil elastase activity may represent a novel adjunctive therapy for transplant recipients suffering acute rejection". Oliver Wiedow, Director of Proteo, Inc., said: "We are excited about these results. They provide further evidence for potential efficacy of Elafin in organ transplantation and give us greater insight into the mechanisms of acute organ rejection".

Further research on this topic is in progress at the Stanford School of Medicine, funded by a grant from the National Heart, Lung and Blood Institute for the study of Elafin's ability to treat three distinct lung diseases.

Source: Jiang et al., Cyclosporine Does Not Prevent Microvascular Loss in Transplantation but Can Synergize With a Neutrophil Elastase Inhibitor, Elafin, to Maintain Graft Perfusion During Acute Rejection, American Journal of Transplantation, 2015 (doi: 10.1111/ajt.13189)

About Elafin

Proteo's pharmaceutical Elafin is a copy of a naturally occurring human anti-inflammatory substance and promises an excellent therapeutic risk-benefit profile. It is a potent inactivator of tissue destroying neutrophil elastase and proteinase-3, and was well tolerated in three randomized, double-blinded, placebo-controlled clinical studies.

Elafin's ability to block tissue destroying proteases makes it a promising drug e.g. for the prevention and treatment of tissue damage occurring in the course of major surgery, pulmonary diseases and severe reperfusion injury in organ transplantation.

Proteo is currently setting up a pivotal phase III clinical trial for the prophylactic treatment of acute postoperative complications following resection of esophageal cancer ("POSTCOM" trial) after a phase II multi-center trial demonstrated that Elafin treated patients needed a significantly shorter stay in the intensive care unit as compared to placebo patients. In a second phase II study in patients undergoing coronary artery bypass surgery (CABG), a significant reduction of the circulating cardiac damage marker Troponin I after 6 hours was observed in Elafin-treated patients. Elafin has obtained orphan drug designations within the EU and US for the use in pulmonary arterial hypertension and esophagus carcinoma surgery.

About Proteo

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. The company has one wholly owned subsidiary, Proteo Biotech AG, Kiel, Germany, where the company's main operations are located. (www.proteo.us)

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