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EANS-News: 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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Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
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Research & Development

Subtitle: 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 (euro adhoc) - 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).

Rajesh Malik, M.D., Chief Medical Officer and Member of the
Management Board, said: "We are extremely disappointed and surprised
with today's results, especially considering the earlier promising
results we had seen in two randomized Phase II trials with
talactoferrin alfa in non-small cell lung cancer. We plan to
thoroughly analyze the data to better understand these results. We
would like to thank all of the patients and investigators who
participated in this clinical trial. We hope that the results of this
study will help to advance scientific knowledge in this area, as
there is an urgent need for new treatment options for patients with
advanced non-small cell lung cancer."

Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of
the Management Board, said: "We are taking immediate steps to
conserve cash while we evaluate our business options. We will
provide more details on our corporate plans in the near future."

The FORTIS-M trial is a randomized, double-blind, placebo-controlled
Phase III trial evaluating talactoferrin plus best supportive care
compared to placebo plus best supportive care in Stage IIIb/IV NSCLC
patients whose disease has progressed following two or more prior
treatment regimens. There were 742 patients enrolled in the trial
from over 160 clinical sites in North America, Europe and the
Asia/Pacific region.

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

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 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 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 press
release. 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 for Europe:
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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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: free trade: Hannover, Berlin, München, Hamburg, Düsseldorf,
regulated dealing/prime standard: Frankfurt
language: English


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