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EANS-Adhoc: AGENNIX AG / Agennix AG Halts Phase II/III OASIS Trial in Severe Sepsis

Geschrieben am 02-02-2012

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ad-hoc disclosure pursuant to section 15 of the WpHG transmitted by euro
adhoc with the aim of a Europe-wide distribution. The issuer is solely
responsible for the content of this announcement.
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Research & Development

02.02.2012

Planegg/Munich (Germany), February 2, 2012 - Agennix AG (Frankfurt
Stock Exchange (Prime Standard): AGX/ISIN DE000A1A6XX4) announced
that, upon the recommendation of the study Data Safety Monitoring
Board (DSMB), the Company has stopped further enrollment and
treatment in the Phase II/III OASIS trial with talactoferrin in
severe sepsis. The DSMB made this recommendation based on a review
of the available data from the trial, which indicated that 28-day
mortality in the talactoferrin arm of the study was greater than in
the placebo arm.

Agennix is unblinding the data from the trial to better understand
these results. A review will be initiated immediately, and, once
completed, the Company will determine its next steps regarding the
development of talactoferrin in severe sepsis and provide additional
information regarding the results of the study. Based on the
available information, these results should have no impact on the
conduct of the ongoing FORTIS-M trial with talactoferrin in non-small
cell lung cancer.

END OF AD HOC ANNOUNCEMENT

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, a
first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI).
Talactoferrin is currently in Phase III clinical trials in non-small
cell lung cancer. Other clinical development programs include
RGB-286638, a multi-targeted kinase inhibitor in Phase I testing for
cancer, 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 ad hoc announcement 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 ad hoc announcement. The
achievement of positive results in early stage clinical studies does
not ensure that later stage or large scale clinical studies will be
successful. 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, there can be no guarantee that
they will be sufficient to gain marketing approval in the United
States or any other country, and 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.

Further inquiry note:
Barbara Mueller
Manager, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565 2693
ir@agennix.com

In the U.S.: Laurie Doyle
Senior Director, Investor Relations & Corporate Communications
Phone: +1 609 524 5884
laurie.doyle@agennix.com

end of announcement euro adhoc
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issuer: 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: free trade: Hannover, Berlin, München, Hamburg, Düsseldorf,
regulated dealing/prime standard: Frankfurt
language: English


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