Phase I/II clinical trial of novel dialysate completed by Zytoprotec

May 23 2012

Zytoprotec, a company developing drugs based on active cytoprotection, today announced the completion of a Phase I/II clinical trial with its lead product, PD-protec™. The product is developed to improve the treatment of patients with kidney failure.

“This randomized cross-over trial has shown that PD-protec™ is safe and well-tolerated”, said Dr. Christoph Aufricht, Chief Scientific Officer of Zytoprotec. “The trial was also designed to provide biological material to be analyzed for indicators of efficacy. While we are currently processing the samples, we see first hints that PD-protec™ may improve survival of abdominal cells in peritoneal dialysis.”

“I am very pleased that Zytoprotec has reached this important clinical milestone for its lead product”, said Peter C. Weilguni, Chief Executive Officer of the Company. “Our development team has demonstrated great discipline and I am confident that we will be able to initiate the Phase II trial with PD-protec™ in autumn this year. We are currently preparing for the financing of this trial, and are in advanced negotiations with a venture fund closely linked to a global pharmaceutical company. “

Karl Altenhuber, co-founder of Zytoprotec and Chairman of its Advisory Board, commented: “I am proud that Zytoprotec advanced from start-up to clinical stage in just five years and built a strong IP-position for its cytoprotective dialysates. It is particularly encouraging to see the substantial interest in the Company and its promising drug programs shown by global pharmaceutical leaders.”

About PD-protec™ and Peritoneal Dialysis
PD-protec™ is a novel dialysate used in peritoneal dialysis (PD), an established treatment for patients suffering from renal failure. Currently the use of PD is limited as PD fluids inevitably damage the cells in the patient’s abdomen. PD-protec™ includes a compound that is designed to actively protect abdominal cells, improving treatment outcomes. The compound is patent-protected by Zytoprotec.

Out of 2 mio patients depending on dialysis, 200,000 are treated with PD. Due to the ageing of the population and a “western” life-style, the number of dialysis patients (including PD) is growing. Improved PD fluids have the potential to significantly expand the proportion of PD within this growing market.

About Zytoprotec
Zytoprotec is a private biotechnology company developing drugs based on active cytoprotection as a novel therapeutic approach. Research by Zytoprotec has shown that in major diseases the capability of cells to protect against stress factors such as metabolic products is inhibited, but can be restored by intervention with cytoprotective pharmaceuticals. The Company has established a research platform for the identification of cytoprotective compounds.

Zytoprotec’s most advanced drug candidate, PD-protec™, recently completed a Phase I/II trial and is being prepared for Phase II clinical development. PD-protec™ is based on a patent-protected cytoprotective compound and is designed to improve survival in renal replacement therapy (peritoneal dialysis).

Other programs focus on the development of cytoprotective therapies for diabetes and other major disease areas.

Zytoprotec’s founders combine extensive experience in business administration, clinical research, pharmaceutical product development, as well as company and patent law. Since its inception in 2007, the Company has raised EUR 6.7 mio from its founders, private and institutional investors, as well as from Austrian public agencies.