Zytoprotec, a biopharmaceutical company developing innovative dialysis fluids, announced today the highly promising outcome of the Phase II study of its peritoneal dialysis fluid PD-protec®. In this double-blind, placebo-controlled cross-over study, the two primary endpoints were successfully met.
The study randomized 50 peritoneal dialysis (PD) patients from eight Austrian centers. PD-protec® was compared to the best currently available PD-fluid. Both endpoints were chosen to reflect clinically highly relevant aspects of PD treatment: (i) a reduced risk of peritoneal membrane failure and (ii) a lower risk of peritonitis. PD-protec® appeared to be well tolerated with no serious adverse events and exhibited a comparable safety profile to the current standard-of-care fluid. No adverse events were observed.
PD-protec® is a novel fluid for peritoneal dialysis, a live-saving therapy for patients with chronic kidney failure. Current PD fluids tend to damage abdominal tissue leading to frequent clinical complications such as peritoneal membrane failure and peritonitis. PD-protec® is designed to alleviate, or even avoid, the side effects of current fluids. The product is targeting a significant improvement of the clinical outcomes of PD, allowing more patients to stay longer on this therapy and thus to lead more mobile and independent lives compared to hemodialysis therapy.
“We are extremely pleased that PD-protec® met both primary endpoints in this Phase II study. We are also very excited about the observation that no study subject, while exposed to PD-protec®, developed peritonitis, whereas four patients experienced peritonitis when treated with standard care,” commented Bernhard Zinner, Managing Director of Zytoprotec. “The clear and strong results in our Phase II trial are a major boost to Zytoprotec's goal of developing a PD-fluid that allows patients to stay longer on this therapy,” Bernd Seibel, Managing Director of Zytoprotec, further added. “We are currently preparing PD-protec® for a pivotal study. As part of this initiative, we are pleased to have retained Nomura Securities International, Inc. as financial advisor to the Company and to assist our Board of Directors in its evaluation of potential strategic and financing alternatives,” Zinner continued.
Prof. Dr. Uwe Schlokat, Chairman of the Zytoprotec Board, stated: “Over the next decade the number of patients suffering from chronic kidney failure is expected to grow to almost 4 million worldwide, posing an immense and increasing burden on patients and 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 in general, and to the quality of life of those affected.”
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 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 restore peritoneal cellular stress response while attenuating sterile inflammation caused by conventional PD fluids.
Bernd Seibel, Managing Director (Financing)
Bernhard Zinner, Managing Director (Business Development)
Tel: +43 (0)1-406 20 02
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