Our ground-breaking research on biomarkers in peritoneal dialysis is directly contributing to the design of an efficient yet scientifically sound pivotal Phase III trial with PDprotec^® that we are currently preparing, and will support the eventual market approval process.

We are collaborating with partners in world-class research bodies and institutions.

During evolution, cells of all species have developed and optimized a powerful mechanism to protect against stress. Every clinically relevant insult therefore not only causes cellular injury but also activates the cellular stress response (Cytoprotection).

However, this mechanism is inhibited in certain diseases or when substances are applied that are “new” from an evolution biology, such as PD solutions.

Research conducted by Zytoprotec has shown that the protective mechanism of cells can be restored by intervention with cytoprotective compounds.

This offers the potential to prevent cells, tissues and whole organs from damage, thereby improving the quality of live and the survival of patients.

With PDprotec^®, Zytoprotec is applying this new approach to the area of renal replacement therapy.

The development of PDprotec^® has led to numerous publications and presentations in medical and scientific journals as well as professional and scientific meetings ever since. Our researchers have not only been publishing in leading journals but also been receiving prestigious awards and prizes in their fields.

Grunert, T., R. Herzog, F.M. Wiesenhofer, A. Vychytil, M. Ehling-Schulz, and K. Kratochwill, Vibrational Spectroscopy of Peritoneal Dialysis Effluent for Rapid Assessment of Patient Characteristics. Biomolecules, 2020. 10(6)
www.ncbi.nlm.nih.gov  |  dx.doi.org

Bartosova, M., R. Herzog, D. Ridinger, E. Levai, H. Jenei, C. Zhang, G.T. González Mateo, I. Marinovic, T. Hackert, F. Bestvater, M. Hausmann, M. López Cabrera, K. Kratochwill, S.G. Zarogiannis, and C.P. Schmitt, Alanyl-Glutamine Restores Tight Junction Organization after Disruption by a Conventional Peritoneal Dialysis Fluid. Biomolecules, 2020.10(8)
res.mdpi.com  |  dx.doi.org

Boehm, M., J. Niewczas, H. Herkner, F. Koenig, K. Kratochwill, P. Rutherford, C. Aufricht, and A. Vychytil, Composite Outcome Improves Feasibility of Clinical Trials in Peritoneal Dialysis. Perit Dial Int, 2019. 39(5): p. 479-485
www.ncbi.nlm.nih.gov  |  dx.doi.org

Boehm, M., R. Herzog, F. Klinglmuller, A.M. Lichtenauer, A. Wagner, M. Unterwurzacher, R.H.J. Beelen, S.L. Alper, C. Aufricht, and K. Kratochwill, The Peritoneal Surface Proteome in a Model of Chronic Peritoneal Dialysis Reveals Mechanisms of Membrane Damage and Preservation. Front Physiol, 2019. 10: p. 472
www.ncbi.nlm.nih.gov  |  dx.doi.org

Wiesenhofer, F.M., R. Herzog, M. Boehm, A. Wagner, M. Unterwurzacher, D.C. Kasper, S.L. Alper, A. Vychytil, C. Aufricht, and K. Kratochwill, Targeted Metabolomic Profiling of Peritoneal Dialysis Effluents Shows Anti-oxidative Capacity of Alanyl-Glutamine. Front Physiol, 2018. 9(1961): p. 1961
www.ncbi.nlm.nih.gov  |  dx.doi.org

Vychytil, A., R. Herzog, P. Probst, W. Ribitsch, K. Lhotta, V. Machold-Fabrizii, M. Wiesholzer, M. Kaufmann, H. Salmhofer, M. Windpessl, A.R. Rosenkranz, R. Oberbauer, F. Konig, K. Kratochwill, and C. Aufricht, A randomized controlled trial of alanyl-glutamine supplementation in peritoneal dialysis fluid to assess impact on biomarkers of peritoneal health. Kidney Int, 2018. 94(6): p. 1227-1237
www.ncbi.nlm.nih.gov  |  dx.doi.org

Herzog, R., M. Boehm, M. Unterwurzacher, A. Wagner, K. Parapatics, P. Majek, A.C. Mueller, A. Lichtenauer, K.L. Bennett, S.L. Alper, A. Vychytil, C. Aufricht, and K. Kratochwill, Effects of Alanyl-Glutamine Treatment on the Peritoneal Dialysis Effluent Proteome Reveal Pathomechanism-Associated Molecular Signatures. Mol Cell Proteomics, 2018. 17(3): p. 516-532
www.ncbi.nlm.nih.gov  |  dx.doi.org

Herzog, R., L. Kuster, J. Becker, T. Gluexam, D. Pils, A. Spittler, M.K. Bhasin, S.L. Alper, A. Vychytil, C. Aufricht, and K. Kratochwill, Functional and Transcriptomic Characterization of Peritoneal Immune-Modulation by Addition of Alanyl-Glutamine to Dialysis Fluid. Sci Rep, 2017. 7(1): p. 6229
www.ncbi.nlm.nih.gov  |  dx.doi.org

For PDprotec^® (registration 2008), the main product of Zytoprpotec, patent protection exists in the following countries (year of grant in paranthesis):

• US (2018)
• Canada (2013)
• Japan (2013)
• all large/economically strong EU countries (2012)
• Switzerland (2012)
• United Kingdom (2012)
• Turkey (2012)
• Hong Kong (2013)
• USA (FDA) Orphan Drug Status

Furthermore, in July 2022, a patent for a “two-chamber bag” including connectors and dialysis fluid was registered with the European Patent Office (“bag patent”). In October 2022 there was positive feedback from the European Patent Office (new and inventive).

The applications of PDprotec^® are continuously being researched and are the subject of another planned patent application (so called “indication”).

In addition to sugar-based dialysis fluids, there are also those that use a polysugar in the dialysis fluid to remove toxins from the patient's blood. With ICOprotec^®, Zytoprotec has also developed an additive for this type of dialysis fluid, which stimulates the peritoneal cells to better protect themselves against their harmful effects. ICOprotec^® is prepared for the start of the first clinical study.

There is patent protection for ICOprotec^® (application 2012) in the following countries (year of grant in brackets):

• US (2018)
• Japan (2017)
• all large/economically strong EU countries (2019)
• Switzerland (2019)
• United Kingdom (2019)
• Canada (2020)
• Turkey (2019)
• China (2019)
• Hong Kong (2020)
• Taiwan (2018)

OMNIprotec is a platform technology making it possible to identify substances, such as alanyl glutamine for PD, which can correct the reduced cellular protective mechanisms that occur in diseases other than renal insufficiency or renal failure, particularly diabetes and hypertension.

The same principle should also be used here that led to the development of PDprotec^®- namely the stimulation of the cell's own protective mechanisms against harmful influences from certain substances in order to enable better treatment of diseases. In diabetes, the cells in all blood vessels are damaged by a permanently high level of sugar in the blood. Hypertension causes physical damage to the cells of all blood vessels because they are constantly exposed to unnaturally high blood pressure and thus to increased shearing forces (abrasion).