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