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Pieris Announces Results and Successful Completion of its PRS-050 Anticalin Phase I Trial at AACR-EORTC-NCI Molecular Targets and Cancer Therapeutics Conference
Date:11/15/2011

SAN FRANCISCO, November 15, 2011 /PRNewswire/ --

Pieris AG presented the results of the Company's first clinical evaluation of its most advanced Anticalin®, PRS-050, an anti-VEGF targeted protein therapeutic, at the 2011 AACR-NCI-EORTC International Conference held in San Francisco, California.  The dose-escalation trial investigated the recommended Phase II dose, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PRS-050 administered to patients with advanced solid tumors.  PRS-050 was well-tolerated, with no maximum tolerated dose reached, while demonstrating biological activity and a complete lack of immunogenicity, supporting further evaluation in a Phase II clinical trial.  

"The Phase I results not only confirm the safety and tolerability of PRS-050, but also are indicative of an attractive safety profile for Anticalins generally," said Dr. Laurent Audoly, Chief Scientific Officer for Pieris AG.  "Moreover, the results of our PK/PD strategy provide human data supporting the robustness of our drug platform.  The Anticalin approach, which in this case, plays on monovalent target engagement, small size and the lack of an effector function, is well-suited for a biobetter VEGF-targeted therapeutic protein approach to treat several types of cancer."

The Phase I clinical trial of PRS-050 was conducted in 26 patients with advanced solid tumors as an open-label, dose-escalating evaluation of the compound's safety, tolerability, and PK/PD profile.  The protein drug exhibited a half-life of six days, there was no immunogenicity (no anti-drug antibodies) observed across all cohorts and multiple dose-dependent PD effects were obtained.  PRS-050 is an anti-VEGF (Vascular Endothelial Growth Factor) 40 kD PEGylated Anticalin discovered and developed internally at the company.  VEGF has a well-defined role in cancer angiogenesis, which is the mechanism by which cancer tumors i
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