EANS-News: Agennix Announces New Data from Talactoferrin Phase II Trials in Non-Small Cell Lung Cancer and in Severe Sepsis Presented at ASCO Annual Meeting

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Research & Development

Planegg/Munich (Germany), Princeton, NJ and Houston, TX, (euro adhoc)
- Agennix AG (Frankfurt Stock Exchange: AGX) announced that new data
from Phase II trials in non-small cell lung cancer and in severe
sepsis demonstrating the activity and tolerability of talactoferrin,
an oral immunotherapy with antibacterial properties, were presented
at the American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago, Illinois.

Talactoferrin appears to improve survival in various prognostic
subsets in Phase II trial in 2nd-line+ non-small cell lung cancer

Data from the Company´s Phase II trial evaluating talactoferrin plus
best supportive care compared to placebo plus best supportive care in
2nd-line+ non-small cell lung cancer (NSCLC) were presented as a
poster, "The effect of talactoferrin on overall survival in
prognostically important NSCLC subsets in a randomized,
placebo-controlled Phase II trial" (abstract #7569). The effect of
talactoferrin on overall survival in this study was seen in a number
of prognostically important patient subsets, including squamous and
non-squamous histologies (tissue types). As previously disclosed,
the trial met its primary endpoint, showing a 65% increase in median
overall survival in the talactoferrin arm compared to control (6.1
months for talactoferrin versus 3.7 months for placebo; hazard ratio
0.68, one-tailed p-value <0.05).

Rajesh Malik, M.D., Chief Medical Officer of Agennix, said:
"Treatment options for non-small cell lung cancer patients with
refractory disease are often limited by, amongst other things, the
histology of their disease, age or the patient´s ability to handle
the toxic side effects of systemic therapy. The data from this
study, although preliminary, suggest that talactoferrin has activity
in various prognostically important subsets. Talactoferrin was also
shown to be very well tolerated, which could provide a significant
advantage for these sick patients, if the safety profile is
reproduced in our ongoing Phase III study."

Dr. Malik continued: "The promising activity and safety data from
this Phase II trial served as the basis for our ongoing Phase III
FORTIS-M trial in advanced non-small cell lung cancer, which
completed enrollment earlier this year. We anticipate top-line
results from the FORTIS-M trial in the first half of 2012."

Overall survival data from a variety of patient subsets were
presented in the poster at ASCO:

Group Subgroup N Hazard Ratio
(90% Confidence Interval)
ITT (overall population) 100 0.68 (0.47, 0.98)

Histology Non-squamous 79 0.70 (0.45, 1.07)
Squamous 21 0.43 (0.16, 1.13)

Gender Male 66 0.62 (0.39, 0.99)
Female 34 0.97 (0.51, 1.83)

Age Group < or = 65 yr 75 0.70 (0.45, 1.08)
>65 25 0.54 (0.25, 1.18)

Disease
Stage IIIB 25 0.61 (0.30, 1.22)
IV 75 0.68 (0.44, 1.06)

Line
of Therapy 2nd 75 0.71 (0.46,1.10)
> or = 3rd 25 0.58 (0.26, 1.28)

ECOG PS 0 23 0.54 (0.24, 1.18)
1 77 0.70 (0.46, 1.08)

Talactoferrin was shown to be very well tolerated in this study, with
fewer adverse events compared to placebo. The most frequently
reported severe adverse event was dyspnea (labored breathing), which
occurred in 15% of patients in the talactoferrin arm and 26% in the
control arm. There were no serious adverse events considered to be
related to treatment with talactoferrin.

Enrollment has completed in the Company´s ongoing Phase III FORTIS-M
trial evaluating talactoferrin plus best supportive care compared to
placebo plus best supportive care in NSCLC patients whose disease has
progressed following two or more prior treatment regimens. Topline
results are expected in the first half of 2012.

Talactoferrin reduces mortality in severe sepsis patients with
different types of infections

Data from a randomized Phase II study that evaluated 190 patients
with severe sepsis who received talactoferrin or placebo were
presented in a poster discussion session, "Consistent mortality
reduction by talactoferrin alfa (TLF) in severe sepsis with different
types of infections" (abstract #9024). As previously reported, the
study met the primary endpoint of reducing 28-day all-cause
mortality. Talactoferrin was shown to have an effect across different
sites and types of infection.

Jeffrey Crawford, M.D., Chief, Division of Medical Oncology, Duke
University School of Medicine, said: "Talactoferrin appears to
reduce mortality in severe sepsis patients while being well tolerated
in this very sick patient population. A Phase II/III trial is
planned in patients with severe sepsis. This could have important
implications for subsequent studies in cancer patients, who are
particularly susceptible to developing sepsis as their immune systems
are often depressed by the treatments they receive, in addition to an
increased risk of infection due to frequent hospitalization,
surgeries and weakness due to illness. Thus it is important to the
cancer care community that effective treatments be found for this
condition."

In the talactoferrin Phase II trial in severe sepsis, the most common
sites of infection were the lungs and blood. There was a consistent
mortality decrease in the talactoferrin arm by sites of infection
with the exception of intra-abdominal infection. A consistent
reduction in mortality also occurred in patients with different types
of infections, such as those caused by a single organism (e.g., a
bacterium or fungus) or multiple organisms.

The above analyses were all conducted on a modified intent-to-treat
(ITT) as treated basis, meaning that patients were evaluated based on
the treatment they actually received (talactoferrin or placebo)
during the first week on study.

Talactoferrin was very well tolerated in the study with no
significant differences between the two treatment arms in frequency
or severity of adverse events. There were no serious adverse events
considered to be related to treatment with talactoferrin.

The Phase II trial was primarily funded by a grant from the U.S.
National Institutes of Health.

Agennix plans to initiate the Phase II portion of a Phase II/III
trial with talactoferrin in severe sepsis in the second quarter of
2011.

About talactoferrin Talactoferrin is an oral immunotherapy with
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. 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
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
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 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:

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

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

Additional investor contact for Europe:
Trout International LLC
Lauren Williams, Vice President
Phone: +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