Zytoprotec Completes Enrollment in Phase II Study With Novel Peritoneal Dialysis Fluid

Conclusion of randomized, double-blinded study expected by end of 2016Joint laboratory for biomarker research in peritoneal dialysis established with Medical University of Vienna

Zytoprotec, a biopharmaceutical company developing innovative, proprietary dialysis fluids with cytoprotective properties, announced today that the last patient has been enrolled in a Phase II study with its lead product, PD-protec®.

PD-protec® is a novel fluid for peritoneal dialysis, a life saving therapy for patients with chronic kidney failure. PD-protec® is designed to alleviate, or even avoid the damage that current fluids cause to abdominal tissue. The product is being developed by Zytoprotec to improve the clinical outcomes of peritoneal dialysis (PD), allowing more patients to stay longer on this therapy and thus lead more mobile and independent lives compared to haemodialysis.

PD-protec® is currently tested in a randomized, double-blinded Phase II clinical trial. 53 patients have been enrolled at 8 study centers in Austria. Zytoprotec expects that the last patient will complete treatment by the end of 2016 and that the results of the trial will be available in the first quarter of 2017.

“We are pleased that the development of our lead product PD-protec® has reached this important milestone”, commented Bernhard Zinner, Managing Director of Zytoprotec. “Over the next decade the number of patients suffering from chronic kidney failure is expected to grow to almost 4 million worldwide. This poses an immense burden on patients and on health-care systems. As PD has obvious benefits for both, a fluid that allows patients to stay longer on this therapy will be a major contribution to the treatment of chronic kidney failure.”

Biomarker Research in Peritoneal Dialysis
The pathomechanisms triggered by exposure to current PD fluids are not fully understood. To advance research in this area Zytoprotec has recently established a Laboratory for Molecular Stress Research in Peritoneal Dialysis.

The Laboratory is set up as a private-public-partnership with the Medical University of Vienna and is part of the Austrian “Christian Doppler Laboratories”, a highly successful framework to bring top level basic research to industrial application. The research group is led by Klaus Kratochwill, PhD, who previously led Zytoprotec's research.

Key focus areas of the Laboratory will be to further elucidate the beneficial effects and the mode of action of PD-protec® and to explore biomarkers in PD, broadening the scientific basis for a Phase III clinical study with PD-protec®.

About Zytoprotec
Zytoprotec is a biopharmaceutical company based in Austria, Europe. Its lead product, PD-protec®, is being developed to improve the treatment of patients with end stage renal failure. Currently, treatment with peritoneal dialysis (PD) is limited as the fluids used in this procedure inherently damage the peritoneal tissue. PD-protec® includes a cytoprotective compound, whose beneficial effects have been discovered by one of Zytoprotec's founders, Prof. Dr. Christoph Aufricht. The compound is expected to protect peritoneal tissue, prolonging the time patients can stay on PD.

In previous Phase I and Phase I/II clinical trials PD-protec® has been shown to be safe and to exhibit protective effects on peritoneal tissue. A Phase II clinical trial with PD-protec® is ongoing.

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