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 Treatments
--------------------------------------------------------------------------------
Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
--------------------------------------------------------------------------------
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