EANS-News: AGENNIX AG Reports Additional Talactoferrin Alfa Data

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Research & Development

Planegg/Munich and Princeton, NJ (euro adhoc) - Agennix AG (Frankfurt
Stock Exchange: AGX) today announced results from several clinical
studies evaluating talactoferrin alfa (talactoferrin).

FORTIS-C Phase III trial with talactoferrin in first-line non-small
cell lung cancer closed early and unblinded; top-line results
announced As previously announced, following the negative results of
the FORTIS-M Phase III trial evaluating talactoferrin in non-small
cell lung cancer (NSCLC) patients whose disease had progressed
following two or more prior treatment regimens, Agennix made the
decision to stop enrollment and analyze the results from the FORTIS-C
Phase III trial. This trial evaluated talactoferrin in combination
with a standard chemotherapy regimen, carboplatin plus paclitaxel,
compared to placebo plus carboplatin and paclitaxel in first-line
NSCLC patients with advanced or metastatic disease (patients who have
not yet been treated for their disease). At the time the FORTIS-C
trial was stopped, 94 of the planned 1,100 patients had been enrolled
and received study drug; all patients were enrolled at five U.S.
sites. The study had co-primary endpoints of progression-free
survival (PFS) and overall survival (OS). Investigator-reported
median PFS in the talactoferrin arm was 5.8 months compared to 5.6
months for placebo(hazard ratio 0.97, p-value 0.89). Median OS in
the talactoferrin arm was 11.4 months compared to 12.7 months for
placebo (hazard ratio 1.25, p-value 0.36). The nature and incidence
of adverse events in the talactoferrin arm were similar to that of
placebo.

Final data reported in Phase I/II study evaluating talactoferrin's
potential to prevent nosocomial infections in pre-term infants The
Company also reported final data from a Phase I/II randomized,
placebo- controlled trial, funded by a U.S. National Institutes of
Health (NIH) grant, evaluating talactoferrin's potential to reduce
the incidence of nosocomial (hospital acquired) infections in infants
born prematurely, which was the primary endpoint. The study enrolled
a total of 120 patients. Ten percent of patients (6 of 60) in the
talactoferrin arm developed nosocomial infections compared to fifteen
percent (9 of 60) in the placebo arm. This difference, while in
favor of talactoferrin, was not statistically significant. The
nature and incidence of adverse events in the talactoferrin arm were
generally similar to that of placebo and consistent with expectations
for the population under study.

Final data from halted OASIS Phase II/III trial in severe sepsis
presented at ISF Sepsis 2012 Final data from the halted OASIS Phase
II/III trial evaluating talactoferrin in adult patients with severe
sepsis were presented in November at the International Sepsis Forum
Sepsis 2012 meeting. Data presented included 28-day and three-month
all-cause mortality. As previously reported, talactoferrin did not
improve 28-day all-cause mortality, the primary endpoint of the
study, nor did it improve mortality at three months. The most
commonly reported adverse events in the study were in line with those
that generally occur with sepsis patients in the intensive care unit
and were generally similar between placebo and talactoferrin.

Rajesh Malik, M.D., Chief Medical Officer, said: "We have performed
extensive analyses of the talactoferrin program to determine if there
is a potential explanation for the outcomes of recent clinical trials
compared to earlier promising results. If the hypotheses generated
from these analyses can be confirmed by additional research, a new
development path forward for talactoferrin may be considered. We
will further update the market as soon as we are in a position to do
so."

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 lengthen and improve the lives of
critically ill patients in areas of major unmet medical need. The
Company's clinical development programs include oral talactoferrin
alfa; a topical gel form of talactoferrin and RGB-286638, a
multi-targeted kinase inhibitor. Agennix's registered seat is in
Heidelberg, Germany. The Company has two sites of operation:
Planegg/Munich, Germany and Princeton, New Jersey. 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 those 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 clinical studies will be
successful. There can be no guarantee that the Company will have or
be able to obtain the financial resources to conduct additional
studies with its product candidates or that it will be successful in
pursuing a strategic transaction. 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 Agennix AG.

Further inquiry note:
Agennix AG
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