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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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.

Further inquiry note:
Agennix AG
Barbara Mueller
Manager, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565 2693
[email protected]

In the U.S.: Laurie Doyle
Senior Director, Investor Relations & Corporate Communications
Phone: +1 609 524 5884
[email protected]

Additional media contact for Europe:
MC Services AG
Raimund Gabriel
Phone: +49 (0) 89 210 228 0
[email protected]

Additional investor contact for Europe:
Trout International LLC
Lauren Williams, Vice President
Phone: +44 207 936 9325
[email protected]
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: [email protected]
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

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