2009-12-01 17:43:55 -
London, December , 01, 2009
Agennix AG / Misc. matters / Ad hoc: Agennix AG Announces Positive
Results with Talactoferrin In
Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial
Ad hoc announcement according to §15 WpHG processed and transmitted
by Hugin. The issuer is solely responsible for the content of this
announcement.
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- Trial results show 45% overall reduction in 28-day all
cause mortality with talactoferrin versus placebo
- Talactoferrin again shown to be very well tolerated
Martinsried/Munich (Germany), Princeton, NJ and Houston, TX, December
1, 2009 - Agennix AG (Frankfurt Stock Exchange: AGX) today reported
results from the talactoferrin randomized, double-blind,
placebo-controlled Phase 2 trial in severe sepsis. The trial
evaluated talactoferrin versus placebo in 190 adult patients with
severe sepsis enrolled at 25 leading centers across the U.S.
Patients in both arms also received standard of care treatment for
severe sepsis in an intensive care unit (ICU) setting. The trial
achieved its primary endpoint of a reduction in 28-day all-cause
mortality. The trial showed a 45% reduction in the 28-day all-cause
mortality from 26.6% in the placebo arm to 14.6% in the talactoferrin
arm (two-tailed p-value = 0.04, odds ratio by logistic regression
analysis = 0.47). The above analyses were conducted on an
intent-to-treat (ITT), as treated basis.
Talactoferrin was shown to be very well tolerated in the study with
no major differences in adverse events between the two treatment
arms.
END OF AD HOC ANNOUNCEMENT
Conference call scheduled
The Company has scheduled a conference call to which participants may
listen via live webcast, accessible through the Agennix Web site at
www.agennix.com or via telephone. A replay will be available on the
Web site following the live event. The call, which will be conducted
in English, will be held on Wednesday, December 2, 2009 at 15:00
CET/9:00 AM ET. The dial-in numbers for the call are as follows:
Participants in Europe: 0049 69 667775756
0044 20 3003 2666
Participants in the U.S.: 1-646 843 4608
Please dial in 10 minutes before the beginning of the call.
About Agennix
Agennix AG is a publicly traded biopharmaceutical company focused on
developing novel anti-cancer therapies. The Company was formed by the
combination of GPC Biotech AG and Agennix Incorporated. The Company's
most advanced program is talactoferrin, an oral targeted therapy that
is in Phase 3 clinical trials in non-small cell lung cancer. 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 wound
healing. Agennix is a transatlantic company with sites in 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. 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.
For further information, please contact:
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 contacts for Europe:
MC Services AG
Phone: +49 (0) 89 210 228 0
Raimund Gabriel
raimund.gabriel@mc-services.eu
Hilda Juhasz
hilda.juhasz@mc-services.eu
Additional investor contact for Europe:
Trout International LLC
Lauren (Rigg) Williams, Vice President
Phone: +44 207 936 9325
lwilliams@troutgroup.com
--- End of Message ---
Agennix AG
Fraunhoferstr. 20 Martinsried Germany
ISIN:
DE000A1A6XX4;
Listed: Regulierter Markt in Frankfurter Wertpapierbörse, Prime
Standard in Frankfurter Wertpapierbörse;
