EANS-News: New Data from Talactoferrin Phase II Trial in Severe Sepsis Presented at American Thoracic Society International Conference

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Research & Development

Planegg/Munich (Germany), Princeton, NJ and Houston, TX (euro adhoc)
- May 19, 2011 - Agennix AG (Frankfurt Stock Exchange: AGX) announced
that new data from a Phase II trial evaluating talactoferrin in the
treatment of patients with severe sepsis were presented at the
American Thoracic Society International Conference in Denver,
Colorado. The double-blind, placebo-controlled trial evaluated
talactoferrin versus placebo in 190 adult patients with severe sepsis
enrolled at 24 leading centers across the U.S. As previously
reported, the Phase II trial achieved its primary endpoint of a
reduction in 28-day all-cause mortality (12.5% absolute reduction,
46.5% relative reduction). The analysis presented at the conference
evaluated the differences in a variety of cytokines and chemokines
(proteins that help to regulate the immune system) in patients
receiving talactoferrin versus placebo. The proteins that were
measured play an important role in the initiation and propagation of
the damaging inflammatory response in severe sepsis. The data were
discussed in an oral presentation entitled, "Reduction in
Cytokines/Chemokines in Severe Sepsis: Results from a Phase II
Randomized Placebo-Controlled Double Blind Trial of Talactoferrin
Alfa in Severe Sepsis," given by Kalpalatha Guntupalli, M.D.,
Professor and Chief, Pulmonary Critical Care and Sleep Medicine,
Baylor College of Medicine and principal investigator of the
talactoferrin Phase II trial.

Dr. Guntupalli said, "The exploratory analyses we conducted suggest
that talactoferrin may be effective in reducing the levels of certain
cytokines and chemokines that are important in the initiation and
propagation of the inflammatory response in severe sepsis. This
provides preliminary evidence of an immunomodulatory effect of
talactoferrin in this clinical setting."

About talactoferrin Talactoferrin is an oral biologic therapy with
immunomodulatory and antibacterial properties, which is being studied
for the treatment of cancer and severe sepsis. Talactoferrin has
demonstrated promising activity in randomized, double-blind,
placebo-controlled Phase II studies in NSCLC and in severe sepsis.
Two Phase III trials with talactoferrin in NSCLC are ongoing, and one
- the FORTIS-M trial - completed enrollment in March 2011. NSCLC is
one of the most common types of cancer worldwide and the most
frequent cause of cancer death. Agennix is also continuing the
development of talactoferrin for the treatment of severe sepsis and
plans to initiate a Phase II/III trial in that indication.
Talactoferrin has been shown to be very well tolerated in these
patient populations.

About Agennix Agennix AG is a publicly listed biopharmaceutical
company that is focused on the development of novel therapies that
have the potential to substantially improve the length and quality of
life of critically ill patients in areas of major unmet medical need.
The Company´s most advanced program is talactoferrin, an oral therapy
that has demonstrated activity in randomized, double-blind,
placebo-controlled Phase II studies in non-small cell lung cancer, as
well as in severe sepsis. Talactoferrin is currently in Phase III
clinical trials in non-small cell lung cancer, and Agennix is also
continuing the development of this program for the treatment of
severe sepsis. Other clinical development programs include
RGB-286638, a multi-targeted kinase inhibitor in Phase I testing, and
a topical gel form of talactoferrin for diabetic foot ulcers.
Agennix´s registered seat is in Heidelberg, Germany. The Company has
three sites of operation: Planegg/Munich, Germany; Princeton, New
Jersey and Houston, Texas. For additional information, please visit
the Agennix Web site at www.agennix.com.

This press release contains forward-looking statements, which express
the current beliefs and expectations of the management of Agennix AG.
Such statements are based on current expectations and are subject to
risks and uncertainties, many of which are beyond our control, that
could cause future results, performance or achievements to differ
significantly from the results, performance or achievements expressed
or implied by such forward-looking statements. Actual results could
differ materially depending on a number of factors, and we caution
investors not to place undue reliance on the forward-looking
statements contained in this press release. There can be no guarantee
that the Company will move talactoferrin forward in development for
severe sepsis in a timely manner, if at all. Even if the results
from our later stage trials with talactoferrin, including the ongoing
FORTIS-M trial in non-small cell lung cancer, are considered
positive, they may not be sufficient to gain marketing approval in
the United States or any other country, and the regulatory
authorities may require additional information, data and/or further
pre-clinical or clinical studies to support approval. In such event,
there can be no guarantee that the Company will have or be able to
obtain the financial resources to conduct any such additional studies
or that such studies will yield results sufficient for approval.
Forward-looking statements speak only as of the date on which they
are made and Agennix undertakes no obligation to update these
forward-looking statements, even if new information becomes available
in the future.

Agennix™ is a trademark of the Agennix group.

end of announcement euro adhoc
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company: AGENNIX AG
Im Neuenheimer Feld 515
D-69120 Heidelberg
phone: +49 89 8565 2693
FAX: +49 89 8565 2610
mail: ir@agennix.com
WWW: http://www.agennix.com
sector: Pharmaceuticals
ISIN: DE000A1A6XX4
indexes: CDAX, Prime All Share, Technology All Share
stockmarkets: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Hamburg, Düsseldorf, Hannover, München
language: English

ots Originaltext: AGENNIX AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Agennix AG
Barbara Mueller
Manager, Investor Relations & Corporate Communications
Tel.: +49 89 8565-2693
ir@agennix.com

In the USA: Laurie Doyle
Senior Director, Investor Relations & Corporate Communications
Tel.: 609-524-5884
laurie.doyle@agennix.com

Additional media contact for Europe:
MC Services AG
Raimund Gabriel
Tel.: +49 89 210 228 0
raimund.gabriel@mc-services.eu

Additional investor contact for Europe:
Trout International LLC
Lauren Williams, Vice President
Tel.: +44 207 936 9325
lwilliams@troutgroup.com

Branche: Pharmaceuticals
ISIN: DE000A1A6XX4
WKN: A1A6XX
Index: CDAX, Prime All Share, Technology All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Düsseldorf / free trade
Hannover / free trade
München / free trade