EANS-News: Agennix Initiates Phase II/III OASIS Trial with Talactoferrin in Severe Sepsis

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Research & Development

Planegg/Munich (Germany), Princeton, NJ and Houston, TX, June 30,
2011 (euro adhoc) - Agennix AG (Frankfurt Stock Exchange: AGX) today
announced that the first patient has been dosed in the Phase II part
of the OASIS (Oral Talactoferrin in Severe Sepsis) trial, a
multicenter, double-blind, randomized Phase II/III trial evaluating
the oral immunotherapy talactoferrin for the treatment of severe
sepsis.

"With over 450,000 people in the U.S. and Europe alone estimated to
die from severe sepsis every year, there is an urgent need for
effective and well tolerated therapies to treat this very sick
patient population," said Rajesh Malik, M.D., Chief Medical Officer.
"Building on the promising results from our earlier Phase II study
with talactoferrin in severe sepsis, the OASIS trial should give us
important insight into the potential utility of talactoferrin as a
treatment for this major unmet medical need."

The OASIS trial is evaluating talactoferrin plus standard care
compared to placebo plus standard care in adult patients with severe
sepsis. The Phase II part of the trial is planned to enroll
approximately 350 patients at clinical sites predominantly in Western
Europe and North America. The study´s primary objective is to
determine the effect of talactoferrin on 28-day all-cause mortality.
Secondary endpoints include three-month, six-month and twelve-month
all-cause mortality. The study will also evaluate the safety and
tolerability of talactoferrin in this patient population, and data
will be collected to further elucidate the mechanism of action of
talactoferrin. Additional information about the trial can be found
at www.clinicaltrials.gov.

About talactoferrin Talactoferrin is an oral immunotherapy that 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 non-small cell
lung cancer (NSCLC) and in severe sepsis. Two Phase III trials with
talactoferrin in NSCLC are ongoing. The FORTIS-M trial, which
completed enrollment in March 2011, is evaluating talactoferrin in
NSCLC patients whose disease has progressed following two or more
prior treatment regimens. A second Phase III trial - FORTIS-C - is
evaluating talactoferrin in combination with the standard
chemotherapy regimen, carboplatin/paclitaxel, in first-line NSCLC
patients. NSCLC is one of the most common types of cancer worldwide
and the most frequent cause of cancer death. Agennix is also
developing talactoferrin for the treatment of severe sepsis and has
initiated a Phase II/III trial, called the OASIS 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
immunotherapy that has demonstrated activity in randomized,
double-blind, placebo-controlled Phase II studies in non-small cell
lung cancer and in severe sepsis. Talactoferrin is currently in Phase
III clinical trials in non-small cell lung cancer, and a Phase II/III
trial with talactoferrin in severe sepsis is underway. 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. 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:
Agennix AG
Barbara Mueller
Manager, Investor Relations & Corporate Communications
Tel.: +49 89 8565-2693
ir@agennix.com

In the U.S.: 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

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