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EANS-Adhoc: Agennix Reports Results of FORTIS-M Phase III Trial with Talactoferrin Alfa in Non-small Cell Lung Cancer

Geschrieben am 06-08-2012

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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/Phase III study results

06.08.2012

- TRIAL DOES NOT ACHIEVE PRIMARY ENDPOINT
- COMPANY TO HOLD CONFERENCE CALL TUESDAY, AUGUST 7TH AT
2 PM CET/8 AM EDT

Planegg/Munich (Germany), Princeton, NJ and Houston, TX, August 6,
2012 - Agennix AG (Frankfurt Stock Exchange: AGX) today announced
that the FORTIS-M Phase III trial with talactoferrin alfa
(talactoferrin) did not meet its primary endpoint of improving
overall survival. The FORTIS-M trial evaluated talactoferrin plus
best supportive care compared to placebo plus best supportive care in
patients with non-small cell lung cancer (NSCLC) whose disease had
progressed following two or more prior treatment regimens. Median
overall survival in the talactoferrin arm was 7.5 months compared to
7.7 months for placebo (hazard ratio 1.04, p-value 0.66).

The nature and incidence of adverse events in the talactoferrin arm
were similar to that of placebo and consistent with previous clinical
trials.

Agennix is taking immediate steps to conserve cash while it evaluates
its business options and will provide more details on its corporate
plans in the near future.

END OF AD HOC ANNOUNCEMENT

Conference Call Scheduled Agennix has scheduled a conference call,
which will be conducted in English, to be held on Tuesday, August 7,
2012 at 8 AM EDT/2 PM CET. A live webcast will be available on the
Agennix Web site at www.agennix.com. A replay will be available via
the Web site following the live event. Dial-in numbers for the call
are as follows:

Participants from Europe: 0049 (0)69 7104 45598
0044 (0)20 3003 2666
Participants from the U.S.: 1 212 999 6659

Please dial in 10 minutes before the beginning of the conference call.

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 lengthen and improve the lives of critically ill
patients in areas of major unmet medical need. The Company's most
advanced investigational agent is talactoferrin alfa, a
first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI).
Talactoferrin alfa is currently being studied for the treatment of
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 adhoc 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 those 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. There can be no
guarantee that the Company will have or be able to obtain the
financial resources to conduct additional studies with talactoferrin
alfa or other product candidates or that such studies will yield
results sufficient for approval. There can be no guarantee that the
Company will be able to partner talactoferrin alfa or obtain
additional financial resources. 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 Agennix AG.

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:
Trout International LLC
Lauren Williams, Senior Vice President
Phone: +44 207 936 9325
lwilliams@troutgroup.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


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