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EANS-News: New Data from Talactoferrin Phase II Trial in Severe Sepsis Presented at American Thoracic Society International Conference
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Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
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Planegg/Munich (Germany), Princeton, NJ and Houston, TX (euro adhoc) - May 19,
2011 - Agennix AG (Frankfurt Stock Exchange: AGX) announced that new data from a
Phase II trial evaluating talactoferrin in the treatment of patients with severe
sepsis were presented at the American Thoracic Society International Conference
in Denver, Colorado. The double-blind, placebo-controlled trial evaluated
talactoferrin versus placebo in 190 adult patients with severe sepsis enrolled
at 24 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
(12.5% absolute reduction, 46.5% relative reduction). The analysis presented at
the conference evaluated the differences in a variety of cytokines and
chemokines (proteins that help to regulate the immune system) in patients
receiving talactoferrin versus placebo. The proteins that were measured play an
important role in the initiation and propagation of the damaging inflammatory
response in severe sepsis. The data were discussed in an oral presentation
entitled, "Reduction in Cytokines/Chemokines in Severe Sepsis: Results from a
Phase II Randomized Placebo-Controlled Double Blind Trial of Talactoferrin Alfa
in Severe Sepsis," given by Kalpalatha Guntupalli, M.D., Professor and Chief,
Pulmonary Critical Care and Sleep Medicine, Baylor College of Medicine and
principal investigator of the talactoferrin Phase II trial.
Dr. Guntupalli said, "The exploratory analyses we conducted suggest that
talactoferrin may be effective in reducing the levels of certain cytokines and
chemokines that are important in the initiation and propagation of the
inflammatory response in severe sepsis. This provides preliminary evidence of
an immunomodulatory effect of talactoferrin in this clinical setting."
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 promising activity in randomized,
double-blind, placebo-controlled Phase II studies in NSCLC and in severe sepsis.
Two Phase III trials with talactoferrin in NSCLC are ongoing, and one - the
FORTIS-M trial - completed enrollment in March 2011. NSCLC is one of the most
common types of cancer worldwide and the most frequent cause of cancer death.
Agennix is also continuing the development of talactoferrin for the treatment of
severe sepsis and plans to initiate a Phase II/III 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 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 is also continuing the development of
this program for the treatment of severe sepsis. 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. There can be no
guarantee that the Company will move talactoferrin forward in development for
severe sepsis in a timely manner, if at all. 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, they may not be sufficient
to gain marketing approval in the United States or any other country, and the
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™ is a trademark of the Agennix group.
Further inquiry note:
Agennix AG
Barbara Mueller
Manager, Investor Relations & Corporate Communications
Tel.: +49 89 8565-2693
ir@agennix.com
In the USA: Laurie Doyle
Senior Director, Investor Relations & Corporate Communications
Tel.: 609-524-5884
laurie.doyle@agennix.com
Additional media contact for Europe:
MC Services AG
Raimund Gabriel
Tel.: +49 89 210 228 0
raimund.gabriel@mc-services.eu
Additional investor contact for Europe:
Trout International LLC
Lauren Williams, Vice President
Tel.: +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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