Pieris Initiates Phase I Clinical Trial for Lead Anticalin Compound

By Pieris Ag, PRNE
Monday, June 14, 2010

Anti-VEGF PRS-050 is First Anticalin Tested in Humans

FREISING-WEIHENSTEPHAN, Germany, June 15, 2010 - Pieris AG announced today the initiation of a Phase I clinical trial in
cancer patients for its lead program, PRS-050, an anti-VEGF Anticalin. The
trial is an open-label, dose-escalating evaluation of the compound's safety
and tolerability in patients with solid tumors. Conducted at three sites in
Germany, the trial is underway and patients from the first cohort have been
dosed.

"Meeting our goal of initiating this trial in the first half of 2010
demonstrates Pieris' commitment to establishing the safety and the
therapeutic relevance of the Anticalin drug class," stated Stephen Yoder, CEO
of Pieris. "Further, the high potency observed in preclinical studies,
together with the small size and the lack of an antibody Fc domain, show
promise of an attractive combined efficacy and safety profile for PRS-050."

The trial is designed to test PRS-050 in approximately 40 patients, who
will receive the compound and then be monitored for safety and tolerability.
The patients recruited for the trial are cancer patients with advanced,
recurrent or metastatic solid tumors, refractory to standard therapy.

PRS-050 is an anti-VEGF (Vascular Endothelial Growth Factor) Anticalin
discovered and developed internally at the company from Pieris' proprietary
Anticalin libraries. PRS-050's mechanism of action is based on its ability to
bind the VEGF ligand, thereby inhibiting tumor growth. VEGF's role in cancer
angiogenesis, the mechanism by which cancer tumors increase blood vessel
development to deliver key nutrients and oxygen is well established, both
scientifically and clinically.

About Pieris

Pieris AG is an independent biotechnology company advancing its
proprietary Anticalin(R) technology to create safer, more efficacious and
more convenient protein therapeutics. Exclusive to Pieris, Anticalin-based
drugs promise to address high-unmet medical needs and expand the therapeutic
potential of current targeted approaches. Pieris' pipeline ranges from its
lead clinical program (anti-VEGF, oncology), to multiple Anticalins in
preclinical development. Pieris will commercialize Anticalin therapeutics
through strategic partnerships, involving both its proprietary pipeline and
its de novo drug discovery capabilities. Its most recent partnership is with
Allergan, Inc. (NYSE: AGN), focusing on novel treatments for eye diseases.
Privately held, Pieris has been funded by premier biotechnology-focused
venture capital, including lead investors OrbiMed Advisors and Global Life
Science Ventures.

For more information, please contact: Pieris AG, Stephen Yoder, CEO,
+49(0)8161-1411-400, info@pieris-ag.com

For more information, please contact: Pieris AG, Stephen Yoder, CEO, +49(0)8161-1411-400, info at pieris-ag.com

Clinical Trials / Medical Discoveries News

June 15 News

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