EANS-Adhoc: AGENNIX AG Agennix AG Halts Phase II/III OASIS Trial in Severe
Sepsis
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ad-hoc disclosure pursuant to section 15 of the WpHG transmitted by euro
adhoc with the aim of a Europe-wide distribution. The issuer is solely
responsible for the content of this announcement.
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Research & Development
02.02.2012
Planegg/Munich (Germany), February 2, 2012 - Agennix AG (Frankfurt Stock
Exchange (Prime Standard): AGX/ISIN DE000A1A6XX4) announced that, upon the
recommendation of the study Data Safety Monitoring Board (DSMB), the Company has
stopped further enrollment and treatment in the Phase II/III OASIS trial with
talactoferrin in severe sepsis. The DSMB made this recommendation based on a
review of the available data from the trial, which indicated that 28-day
mortality in the talactoferrin arm of the study was greater than in the placebo
arm.
Agennix is unblinding the data from the trial to better understand these
results. A review will be initiated immediately, and, once completed, the
Company will determine its next steps regarding the development of talactoferrin
in severe sepsis and provide additional information regarding the results of the
study. Based on the available information, these results should have no impact
on the conduct of the ongoing FORTIS-M trial with talactoferrin in non-small
cell lung cancer.
END OF AD HOC ANNOUNCEMENT
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, a
first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI). Talactoferrin
is currently in Phase III clinical trials in non-small cell lung cancer. Other
clinical development programs include RGB-286638, a multi-targeted kinase
inhibitor in Phase I testing for cancer, 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 ad hoc announcement 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 ad hoc announcement. The
achievement of positive results in early stage clinical studies does not ensure
that later stage or large scale clinical studies will be successful. 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 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
end of announcement euro adhoc
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issuer: 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: free trade: Hannover, Berlin, München, Hamburg, Düsseldorf,
regulated dealing/prime standard: Frankfurt
language: English