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EANS-News: AGENNIX AG / Agennix Announces Data from Talactoferrin Phase II Trial in Severe Sepsis Presented at World Conference on Lung Cancer

Geschrieben am 05-07-2011

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Research & Development

Planegg/Munich (Germany), Princeton, NJ and Houston, TX, July 5, 2011
(euro adhoc) - Agennix AG (Frankfurt Stock Exchange: AGX) announced
that data from a Phase II trial in severe sepsis demonstrating the
activity and tolerability of talactoferrin, an oral immunotherapy,
are being presented this week at the 14th World Conference on Lung
Cancer of the International Association for the Study of Lung Cancer
(IASLC) in Amsterdam, The Netherlands.

Data from a randomized Phase II study that evaluated 190 patients
with severe sepsis who received talactoferrin or placebo are being
presented in a poster, "Talactoferrin alfa (TLF) Reduces Mortality
across a Broad Range of Patients with Severe Sepsis." As previously
reported, the study met the primary endpoint of reducing 28-day
all-cause mortality. Talactoferrin was shown to have an effect across
a broad range of patients with different baseline characteristics.

Jeffrey Crawford, M.D., Chief, Division of Medical Oncology, Duke
University School of Medicine, said: "Talactoferrin appears to
reduce mortality in severe sepsis patients while being well tolerated
in this very sick patient population. A Phase II/III trial in
patients with severe sepsis has recently been initiated. This could
have important implications for subsequent studies in cancer
patients, as they are particularly susceptible to developing sepsis
since their immune systems are often depressed by the treatments they
receive. Cancer patients are also at an increased risk of infection
due to frequent hospitalization, surgeries and weakness due to
illness. Thus it is important to the cancer care community that
effective treatments be found for this condition."

Talactoferrin was very well tolerated in the Phase II study with no
significant differences between the two treatment arms in frequency
or severity of adverse events. 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.

About talactoferrin Talactoferrin is an oral immunotherapy that 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 non-small cell
lung cancer (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
developing talactoferrin for the treatment of severe sepsis and has
initiated a Phase II/III trial, called the OASIS 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
immunotherapy 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 a Phase II/III
trial with talactoferrin in severe sepsis is underway. 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, there can be no guarantee that they will be sufficient to
gain marketing approval in the United States or any other country,
and 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.

Further inquiry note:
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:
Trout International LLC
Lauren Williams, Vice President
Phone: +44 207 936 9325
lwilliams@troutgroup.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: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Hamburg, Düsseldorf, Hannover, München
language: English


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