EANS-News: AGENNIX Announces Publication of Data from Talactoferrin Phase II Trial in First-Line Non-Small Cell Lung Cancer Published in Journal of Thoracic Oncology

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Research & Development

Planegg/Munich (Germany), Princeton, NJ and Houston, TX (euro adhoc)
- Agennix AG (Frankfurt Stock Exchange: AGX) has announced the
publication of a Phase II randomized, double-blind,
placebo-controlled clinical trial evaluating the Company's lead
product candidate, oral talactoferrin, in first-line non-small cell
lung cancer (NSCLC) in the peer-reviewed medical journal, Journal of
Thoracic Oncology. The publication, "A Randomized, Double-Blind,
Placebo-Controlled Phase II Study of Oral Talactoferrin in
Combination with Carboplatin and Paclitaxel in Previously Untreated
Locally Advanced or Metastatic Non-small Cell Lung Cancer" by R.
Digumarti et al, appears in the June 2011 issue of the journal. As
previously reported, this study achieved its primary endpoint of
improvement in confirmed response rate in the evaluable population.
Supportive results were seen in the secondary endpoints of
progression-free survival and overall survival. Talactoferrin
appeared to be well tolerated with a statistically significant
decrease in adverse events compared to placebo.

"The results from this study show the potential activity, as well as
good tolerability, of talactoferrin in this clinical setting," said
Rajesh Malik, M.D., Chief Medical Officer. "These data provide
support for the ongoing Phase III development program with
talactoferrin in non-small cell lung cancer. Our Phase III trial,
FORTIS-M, evaluating talactoferrin in non-small cell lung cancer
patients whose disease has progressed following two or more prior
treatment regimens, completed enrollment earlier this year, and we
expect top-line results from that study in the first half of 2012."

The published Phase II trial involved 110 randomized patients with
previously untreated stage IIIB/IV non-small cell lung cancer and
evaluated the use of talactoferrin in combination with the standard
chemotherapy regimen, carboplatin plus paclitaxel, compared to
placebo plus the same chemotherapy treatment. The results showed
that talactoferrin increased the confirmed response rate compared to
placebo. The response rate in the 100-patient evaluable population,
which was the pre-defined primary endpoint, increased from 29%
(placebo) to 47% (talactoferrin) (one-tailed p-value = 0.05), meeting
the pre-specified level of statistical significance for the primary
endpoint. The evaluable population was defined as patients who
received at least one dose of study drug and had at least one CT scan
after the start of treatment, which is necessary to determine a
response rate. The response rate in the 110-patient intent-to-treat
population increased from 27% to 42% (one-tailed p=0.08). The
maximum duration of treatment with talactoferrin or placebo was 18
weeks, as treatment was stopped at the same time treatment with
carboplatin/paclitaxel was discontinued, even in the absence of
disease progression. Median progression-free survival, overall
survival, and duration of response were also longer in the
talactoferrin arm, although the differences were not statistically
significant.

In the study, talactoferrin appeared to be well tolerated. Patients
who received talactoferrin had fewer total adverse events (two-tailed
p=0.003), grade 3 or 4 adverse events (p=0.05), adverse events
related to study drug or chemotherapy, incidence of serious adverse
events, and discontinuations due to adverse events. The most
frequently reported adverse events occurred at comparable rates in
the two arms and were consistent with those typically observed in
NSCLC patients undergoing chemotherapy, including myelotoxicity
(affecting bone marrow), gastrointestinal disorders, respiratory
disorders and alopecia (hair loss).

About talactoferrin Talactoferrin is an oral biologic therapy with
immunomodulatory and 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 therapy
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. 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(TM) 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:

Agennix AG
Barbara Mueller
Manager, Investor Relations & Corporate Communications
Tel.: +49 89 8565-2693
ir@agennix.com

In the USA: 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

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