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

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Research & Development


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

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 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

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		
In the U.S.: Laurie Doyle		
Senior Director, Investor Relations & Corporate Communications		
Phone: +1 609 524 5884	
Additional media contact for Europe:	
MC Services AG	
Raimund Gabriel	
Phone: +49 (0) 89 210 228 0			
Additional investor contact for Europe:	
Trout International LLC	
Lauren Williams, Senior Vice President	
Phone: +44 207 936 9325

end of announcement                               euro adhoc 

company:     AGENNIX AG
             Im Neuenheimer Feld 515
             D-69120 Heidelberg
phone:       +49 89 8565 2693
FAX:         +49 89 8565 2610
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

Weitere Meldungen: AGENNIX AG

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