Preclinical and interim Phase I clinical trial data for PRS-050 (Angiocal?, Pieris AG), currently under evaluation for the treatment of various forms of solid tumors, was presented today at the Molecular Medicine Tri-Conference by Dr. Laurent Audoly, Chief Scientific Officer of Pieris AG in San Francisco. His presentation is titled, “Pre-clinical and Interim Phase I of PRS-050 – a Unique and Novel Non-Fc Domain Biobetter VEGF-A Antagonist for the Treatment of Solid Tumors”.

The ongoing Phase I clinical trial of PRS-050 is an open-label, dose-escalating evaluation of the compound’s safety and tolerability in patients with solid tumors. PRS-050 is an anti-VEGF (Vascular Endothelial Growth Factor) 40 kD PEGylated Anticalin discovered and developed internally at the company.

During the first half of 2010, the compound began the clinical trial at three different sites in Germany. To date, Pieris, an independent, clinical-staged biotechnology company, has amassed a strong preclinical data package of in vivo efficacy in multiple models and a positive safety profile, including encouraging data supporting its differentiated activities to improve or complement current anti-VEGF therapeutics, based primarily on the absence of an Fc domain and mode of target engagement.

This is a phase I, open-label, dose escalation study with Angiocal? in patients with solid tumors using a group sequential adaptive treatment assignment. The trial was designed to test PRS-050 in approximately 42 patients, who receivedthe compound and were thenmonitored for safety and tolerability. The participantsrecruited for the trial werepatients with advanced, recurrent or metastatic solid tumors, refractory to standard therapy.

Patients in the trial were allocated to different dose levels in small cohorts and will receive one single dose application on Day 1, followed by a repeated dosing period. The primary objective of the study was to evaluate the safety and tolerability of Angiocal? when administered intravenously to patients with solid tumors. The secondary objectives of the study are the characterization of the pharmacodynamic response, evaluation of the pharmacokinetic profile of Angiocal?, observation of tumor response.

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Pieris’ proprietary Anticalin technology platform is desgined to creates the ‘next generation’ targeted therapeutics and addresses targets in ways that traditional methods cannot. Anticalins are recombinantly engineered lipocalins, endogenous low-molecular weight human proteins that naturally bind, store and transport a wide spectrum of molecules. To obtain a specific Anticalin, Pieris applies its deep protein engineering know-how to select drug candidates from its suite of rationally designed proprietary Anticalin libraries.

For more information:
Study of Angiocal? in Patients With Solid Tumors, Investigating Safety, Tolerability, Blood Concentration of Study Drug.

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