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EANS-News: Agennix AG Announces Notice of Allowance for U.S. Patent Application Covering Use of Talactoferrin Alfa to Treat Non-Small Cell Lung Cancer and Renal Cancer in Combination with Other Trea

Geschrieben am 30-07-2012

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Corporate news transmitted by euro adhoc. The issuer/originator is solely
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Patents, Copyright & Trademarks

Planegg/Munich (Germany), Princeton, NJ and Houston, TX, July 30,
2012 (euro adhoc) - Agennix AG (Frankfurt Stock Exchange (Prime
Standard): AGX) today announced that the U.S. Patent and Trademark
Office has issued a Notice of Allowance for patent application US
12/964,327, entitled, "Lactoferrin in the treatment of malignant
neoplasms and other hyperproliferative diseases." The patent
application covers the use of the oral Dendritic Cell Mediated
Immunotherapy (DCMI) talactoferrin alfa (talactoferrin) for the
treatment of non-small cell lung cancer (NSCLC) and renal cancer in
combination with chemotherapy, biotherapy, immunotherapy, surgery,
radiotherapy, or a combination thereof.

Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of
the Management Board, said: "This patent allowance broadens the
coverage of talactoferrin alfa for the treatment of non-small cell
lung cancer and renal cancer to include combinations with a wide
range of other anti-cancer treatments, such as chemotherapy, biologic
therapies and immunotherapies. This is important because it further
strengthens our intellectual property position for talactoferrin alfa
in areas which we consider priorities for further clinical and
commercial development. For example, our Phase III FORTIS-C trial is
evaluating talactoferrin alfa in combination with a common
chemotherapy regimen, carboplatin/paclitaxel, in first-line non-small
cell lung cancer."

Dr. Hombeck continued: "We expect data from our most advanced Phase
III trial - FORTIS-M - evaluating talactoferrin alfa as a monotherapy
in non-small cell lung cancer patients whose disease has progressed
following two or more prior treatment regimens in the near future."

About talactoferrin alfa Talactoferrin alfa is an investigational
first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI)
currently being studied for the treatment of NSCLC. Oral DCMIs have
the potential to harness a patient's own immune system to mount a
personal response against his or her cancer. Two randomized,
double-blind, placebo-controlled Phase II studies in NSCLC achieved
their primary endpoints. In both of these studies, the occurrence of
adverse events was statistically significantly lower in the
talactoferrin arm compared to the placebo group. Two Phase III
trials with talactoferrin in NSCLC are ongoing. The FORTIS-M trial is
evaluating talactoferrin in NSCLC patients whose disease has
progressed following two or more prior treatment regimens, and data
from this trial are expected in July/August 2012. A second Phase III
trial - FORTIS-C - is evaluating talactoferrin in combination with
the standard chemotherapy regimen, carboplatin/paclitaxel, in
first-line NSCLC patients. NSCLC is one of the most common types of
cancer worldwide and the most frequent cause of cancer death.

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 in Phase III clinical trials in
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,
including statements about the timing of clinical trial results. 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. Even if the results from our later stage
trials with talactoferrin, including the ongoing FORTIS-M trial in
non-small cell lung cancer, are considered positive, there can be no
guarantee that they will be sufficient to gain marketing approval in
the United States or any other country, and regulatory authorities
may require additional information, data and/or further pre-clinical
or clinical studies to support approval. In such event, there can be
no guarantee that the Company will have or be able to obtain the
financial resources to conduct any such additional studies or that
such studies will yield results sufficient for approval. Even if the
results from the FORTIS-M trial are considered positive, there can be
no guarantee that the Company will be able to partner talactoferrin
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
--------------------------------------------------------------------------------

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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