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