EANS-News: Agennix Announces Data from Talactoferrin Phase II Trial in Non-Small Cell Lung Cancer Published in Journal of Clinical Oncology

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Research & Development

Planegg/Munich (Germany), Princeton, NJ and Houston, TX (euro adhoc)
- October 11, 2011 - Agennix AG (Frankfurt Stock Exchange: AGX) today
announced that data from a Phase II randomized, double-blind,
placebo-controlled clinical trial evaluating the oral immunotherapy,
talactoferrin, in patients with previously treated non-small cell
lung cancer (NSCLC) have been published in the peer-reviewed medical
journal, Journal of Clinical Oncology. The article, "A Randomized,
Double-Blind, Placebo-Controlled Phase II Study of Oral Talactoferrin
in Patients with Locally Advanced or Metastatic Non-Small Cell Lung
Cancer that Progressed Following Chemotherapy," by P. Parikh et al,
will appear in the November 1, 2011 print issue of the journal. As
previously reported, this study, conducted in patients with NSCLC for
whom one or more prior lines of anti-cancer therapy had failed,
achieved its primary endpoint of improvement in overall survival.
Talactoferrin also appeared to improve survival across a broad range
of patient subsets, including those with squamous and non-squamous
histologies, as well as other important prognostic factors. The
results of this study served as the basis for the ongoing
talactoferrin Phase III FORTIS-M trial, which is being conducted in
patients whose disease has progressed following two or more prior
treatment regimens. The FORTIS-M study has completed enrollment and
topline results are expected in the first half of 2012.

"There is a major need for effective, easy-to-use, well tolerated
treatments for patients with refractory non-small cell lung cancer,"
said Rajesh Malik, M.D., Chief Medical Officer. "The promising
results from this study show the potential of talactoferrin to
improve survival where previous therapies have failed, including
effects across a broad range of clinically important subsets.
Talactoferrin appears to provide anti-tumor activity without many of
the common toxicities associated with other treatments for non-small
cell lung cancer. In addition, talactoferrin is an oral liquid that
offers convenience for both patients and physicians to use. We look
forward to reporting topline results from our ongoing Phase III
FORTIS-M registration trial in advanced non-small cell lung cancer in
the first half of 2012."

The published randomized Phase II trial enrolled 100 patients with
stage IIIB/IV non-small cell lung cancer whose disease had progressed
following one or more lines of anti-cancer therapy and evaluated the
use of talactoferrin plus best supportive care compared to placebo
plus best supportive care. The results showed that talactoferrin
improved median overall survival by 65% compared to placebo [6.1
months versus 3.7 months, hazard ratio = 0.68, 90% Confidence
Interval: 0.47-0.98, p=0.04 (one-tailed log-rank test)], meeting the
protocol-defined level of statistical significance. The six-month
overall survival rate was 30% in the placebo arm and 52% in the
talactoferrin arm. The one-year overall survival rate was 16% in the
placebo arm compared to 29% in the talactoferrin arm. Supportive
results were seen in the secondary endpoints of progression-free
survival and disease control rate. The above analyses were conducted
on an intent-to-treat basis.

Talactoferrin was shown to be very well tolerated in this study, with
fewer adverse events compared to placebo. The most frequently
reported severe (grade 3 or greater) 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.

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 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. 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:
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
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