EANS-News: AGENNIX AG / Agennix AG Announces Data from Talactoferrin Randomized, Double-Blind, Placebo-Controlled Phase II Trial in Severe Sepsis Presented at the Sepsis 2010 International Symposium

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Research & Development/Severe Sepsis

Heidelberg (euro adhoc) - Planegg/Munich (Germany), Princeton, NJ and
Houston, TX, September 3, 2010 - Agennix AG (Frankfurt Stock
Exchange: AGX) announced that data from a Phase II trial with
talactoferrin in severe sepsis were presented today at the Sepsis
2010 International Symposium, which was hosted by the International
Sepsis Forum, in Paris, France. 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 from 26.9% in the
placebo arm to 14.4% in the talactoferrin arm (two-tailed p-value
adjusted for cardiovascular dysfunction = 0.05, odds ratio by
logistic regression analysis = 0.48), a 46% relative reduction (12.5%
absolute reduction).

Steven Opal, M.D., Professor of Medicine, Infectious Disease
Division, Alpert Medical School, Brown University, Providence, Rhode
Island, presented the data. Dr. Opal said: "There is an urgent need
for more effective treatment options for patients with severe sepsis,
a challenging to treat condition that affects over 750,000 people in
the U.S. annually and a similar number in Europe. The results of
this Phase II trial indicate that talactoferrin has the potential to
reduce mortality in patients with severe sepsis while being well
tolerated in this very sick patient population. These results
warrant additional study of talactoferrin to treat this condition."

The Phase II trial was primarily funded by a $3 million grant from
the U.S. National Institutes of Health.

Agennix plans to start an initial Phase III trial with talactoferrin
in severe sepsis in early 2011.

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. An estimated
30-35% of people with severe sepsis are expected 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.
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; the oral
platinum-based compound satraplatin; 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 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

Investor Relations & Corporate Communications

Phone: +49 (0)89 8565 2693

ir@agennix.com

In the U.S.: Laurie Doyle

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:

Trout International LLC

Lauren Williams, Vice President

Phone: +44 207 936 9325

lwilliams@troutgroup.com

Branche: Pharmaceuticals
ISIN: DE000A1A6XX4
WKN: A1A6XX
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