Zytoprotec GmbH Phase II Peritoneal Dialysis Study: Last Patient Out
11/14/2016 11:06:50 AM
• 53 patients treated with PD fluid designed to improve outcomes of PD
• Cross-over trial design to provide validity of several times larger conventional trials
• Data on cytoprotective effect of PD-protec® to be presented at ASN Meeting
Vienna, Austria, November 14, 2016 / B3C newswire / -- Zytoprotec, a biopharmaceutical company developing innovative dialysis fluids with cytoprotective properties, announced today that the last patient has completed treatment in a Phase II study with its lead product, PD-protec®. The Company expects results of this trial to be available in the first quarter of 2017.
PD-protec® is a novel fluid for peritoneal dialysis (PD), a live-saving therapy for patients with chronic kidney failure. Current PD fluids tend to damage abdominal tissue, limiting the use of this convenient and cost effective therapy. By contrast, PD-protec® is designed to alleviate, or even avoid, the damage from 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 haemodialysis.
53 patients were treated with PD-protec® in a randomized, double-blinded Phase II clinical trial.
“We are very pleased that we will soon be analyzing clinical and molecular biology data from this study”, commented Bernhard Zinner, Managing Director of Zytoprotec. “Due to its innovative cross-over design, the results of this study will have the statistical power of a conventional study with several times the number of patients.”
“Upon final evaluation of the results we plan to prepare PD-protec® for a pivotal study together with industrial or other partners”, Zinner continued. “Meanwhile, we are pleased that data on the cytoprotective effect of PD-protec® will be presented at the upcoming Annual Meeting of the American Society of Nephrology (ASN) in Chicago.”
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 (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 restore peritoneal cellular stress response while attenuating sterile inflammation caused by conventional PD fluids.
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