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

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Research & Development

Planegg/Munich (Germany), February 2, 2012 (euro adhoc) - 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.

"We are extremely disappointed and surprised by this result," said
Rajesh Malik, M.D., Chief Medical Officer of Agennix. "Given the
challenge of treating this life-threatening condition, we had made
the decision prior to initiating the OASIS trial to obtain additional
clinical data before entering a large Phase III study. We will look
closely at the data to better understand these results and to
determine the best next steps related to further development of
talactoferrin for the treatment of severe sepsis."

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 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. 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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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: free trade: Hannover, Berlin, München, Hamburg, Düsseldorf,
regulated dealing/prime standard: Frankfurt
language: English