Agennix AG (FRANKFURT: AGX) (XETRA: AGX) today announced the
completion of patient enrollment in the talactoferrin FORTIS-M Phase
III registration trial. The FORTIS-M trial is a global randomized,
double-blind trial evaluating talactoferrin plus best supportive care
compared to placebo plus best supportive care in patients with
non-small cell lung cancer (NSCLC) whose disease has progressed
following two or more prior treatment regimens. The study enrolled 742
patients at over 160 sites globally.
"We are excited to have accomplished this important milestone in the
development of talactoferrin by completing accrual in the FORTIS-M
trial within the expected timeline," said Rajesh Malik, M.D., Chief
Medical Officer. "There is a major need for effective and
well-tolerated treatments for non-small cell lung cancer patients
whose disease has already progressed after multiple therapies. I would
like to thank the clinical investigators and study site personnel for
their dedication, as well as the patients and their families who are
participating in the trial."
The Company also provided an update on the anticipated availability of
topline data from the FORTIS-M trial. Agennix now expects to see these
data in the first half of 2012. This updated timeline is based on
currently available information on the number of blinded death events
in the study and is subject to further change. The Company will
provide updates as appropriate when more information becomes
available.
About non-small cell lung cancerLung cancer is one of the most
commonly diagnosed cancers worldwide and is the leading cause of
cancer-related deaths around the globe. In the U.S., more people die
of lung cancer than of colon, breast and prostate cancers combined. It
is estimated that there were over 222,000 new cases of lung cancer in
the U.S. in 2010 and over 157,000 deaths due to this disease. Recent
statistics estimate that over 287,000 people in the European Union
(EU) were diagnosed with lung cancer in 2008, and approximately
252,000 people in the EU died from this disease. According to the
American Cancer Society, NSCLC accounts for approximately 85% of all
newly diagnosed lung cancer in the U.S. The symptoms of lung cancer
usually do not appear until the disease is already in an advanced
stage. Thus, over 50% of NSCLC cases are already metastatic and not
curable at the time of diagnosis. Despite recent advances in the
treatment of this disease, NSCLC continues to be a major area of unmet
medical need around the world.
About talactoferrinTalactoferrin is an oral biologic therapy with
immunomodulatory and antibacterial properties, which is being studied
for the treatment of cancer and severe sepsis. Talactoferrin has
demonstrated activity in randomized, double-blind, placebo-controlled
Phase II studies in non-small cell lung cancer (NSCLC), as well as in
severe sepsis, a condition with significant mortality marked by severe
inflammation in response to a serious infection. As a result of the
promising results from Phase II studies, two Phase III trials with
talactoferrin in NSCLC are ongoing. Agennix also plans to develop
talactoferrin further for the treatment of severe sepsis and plans to
initiate a Phase II/III trial in that indication. Talactoferrin has
been shown to be very well tolerated in these patient populations.
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 improve the length and quality of life of critically
ill patients in areas of major unmet medical need. The Company's most
advanced program is talactoferrin, an oral therapy that has
demonstrated activity in randomized, double-blind, placebo-controlled
Phase II studies in non-small cell lung cancer, as well as in severe
sepsis. Talactoferrin is currently in Phase III clinical trials in
non-small cell lung cancer, and Agennix plans to develop this program
further for the treatment of severe sepsis. Other clinical development
programs include RGB-286638, a multi-targeted kinase inhibitor in
Phase I testing, 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
(http://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 the results, performance or achievements 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. There can be no guarantee
that the results of the FORTIS-M trial or other ongoing studies with
talactoferrin will be obtained when expected, will be positive or will
be adequate to support a marketing approval. Additionally, there can
be no guarantee that talactoferrin will be approved for marketing in
any country or at all. 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 the Agennix group.