EANS-News: AGENNIX AG / Agennix AG Announces Longer-Term Mortality Data from Talactoferrin Phase II Trial in Severe Sepsis Presented at 40th Critical Care Congress

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Research & Development/Clinical Data - Sepsis

Heidelberg (euro adhoc) - Planegg/Munich (Germany), Princeton, NJ and
Houston, TX, January 17, 2011 - Agennix AG (Frankfurt Stock Exchange:
AGX) announced that new and more detailed data from a Phase II trial
in severe sepsis with talactoferrin, an oral biologic therapy with
immunomodulatory and antibacterial properties, were presented at the
40th Critical Care Congress of the Society of Critical Care Medicine
in San Diego, California. The double-blind, placebo-controlled trial
evaluated talactoferrin versus placebo in 190 adult patients with
severe sepsis enrolled at 25 leading centers across the U.S. As
previously reported, the Phase II trial achieved its primary endpoint
of a reduction in 28-day all-cause mortality (13% absolute
reduction). The presentation reported that the effect of
talactoferrin on reduction in all-cause mortality was sustained at
three and six months. The reduction in mortality was seen in patients
with and without cardiovascular dysfunction. However, there appeared
to be a greater, significant effect in patients without
cardiovascular dysfunction, which is consistent with the effect seen
on 28-day mortality.

Mitchell M. Levy, M.D., Professor of Medicine at Brown Medical School
and Medical Director of the Medical Intensive Care Unit at Rhode
Island Hospital, Providence, Rhode Island, presented the data. Dr.
Levy said: "There is an urgent need for more effective treatment
options for patients with severe sepsis, which affects over 750,000
patients annually in the U.S. alone. The results of this Phase II
trial indicate that talactoferrin has the potential to reduce
mortality in patients with severe sepsis while being very well
tolerated and that the results are sustained over time to at least
six months. These results warrant additional study of talactoferrin
to treat this serious condition."

The following results were reported: Three-month all-cause mortality
was 29.7% in the placebo arm compared to 17.9% in the talactoferrin
arm, an absolute reduction of 12% (two-tailed p-value adjusted for
cardiovascular dysfunction = 0.09). For patients with
cardiovascular dysfunction, there was an absolute reduction of 7% in
three-month all-cause mortality with 32.8% in the placebo arm
compared to 26.3% in the talactoferrin arm. For patients without
cardiovascular dysfunction, there was an absolute reduction of 18%
with 23.3% in the placebo group and 5.3% in the talactoferrin group.

At six months, there was a statistically significant reduction in
all-cause mortality from 35.6% in the placebo arm to 21.1% in the
talactoferrin arm, an absolute reduction of 15% (p-value = 0.04). For
patients with cardiovascular dysfunction, there was an absolute
reduction of 10% in six-month all cause mortality with 38.3% in the
placebo arm compared to 28.1% in the talactoferrin arm. For patients
without cardiovascular dysfunction, there was an absolute reduction
in six-month all cause mortality of 20% with 30.0% in the placebo
group and 10.5% in the talactoferrin group.

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. Three-month and six-month all-cause
mortality were secondary endpoints in the trial.

Talactoferrin was very well tolerated in the study with no
significant differences in adverse events between the two treatment
arms. Of those adverse events considered to be possibly related to
treatment, the most frequently reported category in both treatment
groups was gastrointestinal disorders (5.5% of patients in the
talactoferrin arm and 5.4% in the placebo arm). 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 March or April 2011.

Echocardiogram assessment of cardiac function also presented In a
poster entitled, "Talactoferrin may confer increased survival in
patients with septic shock and systolic cardiac dysfunction,"
echocardiogram data from patients at four clinical sites in the Phase
II trial with talactoferrin in severe sepsis were presented.
Forty-six patients were enrolled at the sites and had an
interpretable echocardiogram within 24 hours preceding or following
randomization. Among the 33 patients with septic shock and abnormal
systolic function (heart contraction), talactoferrin therapy may be
associated with improved survival.

About severe sepsis Sepsis is a condition involving infection and
generalized inflammation. The body's normal response to an infection
is to set off a limited chain reaction to fight the infection. In
severe sepsis, this systemic immune response becomes overactive and
results in damage to vital body organs, leading to a shutdown of one
or more organs and, in many cases, death. Each year, approximately
750,000 people in the U.S. develop severe sepsis, and a similar
number of people are affected in Europe. Due to the aging of the
population, this number is expected to grow over time. More than 30%
of people with severe sepsis are estimated to die annually from this
condition in the U.S., and the U.S. Centers for Disease Control and
Prevention indicates that sepsis is one of the top ten leading causes
of death in the U.S. Patients suffering from severe sepsis must be
hospitalized, often in an intensive care unit, and the medical costs
to treat sepsis were estimated in 2001 to be over $16 billion in the
U.S. alone, a number that is believed to have increased significantly
over time.

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 activity in randomized, double-blind, placebo-controlled
Phase II studies in non-small cell lung cancer (NSCLC), as well as in
severe sepsis. As a result of the promising results from Phase II
studies, two Phase III trials with talactoferrin in NSCLC have been
initiated. NSCLC is one of the most common types of cancer worldwide
and the most frequent cause of cancer death. Agennix also plans to
develop talactoferrin further for the treatment of severe sepsis and
expects to initiate the Phase II portion of a Phase II/III trial in
that indication in March/April 2011. 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, as
well as in severe sepsis. Talactoferrin is currently in Phase III
clinical trials in non-small cell lung cancer, and Agennix plans to
develop this program further for the treatment of severe sepsis.
Other clinical development programs include RGB-286638, a
multi-targeted kinase inhibitor in Phase 1 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. There can be no
guarantee that the Company will move talactoferrin forward in
development for severe sepsis in a timely manner, if at all, or that
talactoferrin will ultimately be approved for sale in any indication
in any country. 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. 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.

end of announcement euro adhoc
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ots Originaltext: AGENNIX AG
Im Internet recherchierbar: http://www.presseportal.de

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

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:
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Lauren Williams, Vice President
Phone: +44 207 936 9325
lwilliams@troutgroup.com

Branche: Pharmaceuticals
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