EANS-News: AGENNIX Announces Publication of Data from Talactoferrin Phase II Trial in First-Line Non-Small Cell Lung Cancer Published in Journal of Thoracic Oncology

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Planegg/Munich (Germany), Princeton, NJ and Houston, TX (euro adhoc) - Agennix
AG (Frankfurt Stock Exchange: AGX) has announced the publication of a Phase II
randomized, double-blind, placebo-controlled clinical trial evaluating the
Company's lead product candidate, oral talactoferrin, in first-line non-small
cell lung cancer (NSCLC) in the peer-reviewed medical journal, Journal of
Thoracic Oncology. The publication, "A Randomized, Double-Blind,
Placebo-Controlled Phase II Study of Oral Talactoferrin in Combination with
Carboplatin and Paclitaxel in Previously Untreated Locally Advanced or
Metastatic Non-small Cell Lung Cancer" by R. Digumarti et al, appears in the
June 2011 issue of the journal. As previously reported, this study achieved its
primary endpoint of improvement in confirmed response rate in the evaluable
population. Supportive results were seen in the secondary endpoints of
progression-free survival and overall survival. Talactoferrin appeared to be
well tolerated with a statistically significant decrease in adverse events
compared to placebo.

"The results from this study show the potential activity, as well as good
tolerability, of talactoferrin in this clinical setting," said Rajesh Malik,
M.D., Chief Medical Officer. "These data provide support for the ongoing Phase
III development program with talactoferrin in non-small cell lung cancer. Our
Phase III trial, FORTIS-M, evaluating talactoferrin in non-small cell lung
cancer patients whose disease has progressed following two or more prior
treatment regimens, completed enrollment earlier this year, and we expect
top-line results from that study in the first half of 2012."

The published Phase II trial involved 110 randomized patients with previously
untreated stage IIIB/IV non-small cell lung cancer and evaluated the use of
talactoferrin in combination with the standard chemotherapy regimen, carboplatin
plus paclitaxel, compared to placebo plus the same chemotherapy treatment. The
results showed that talactoferrin increased the confirmed response rate compared
to placebo. The response rate in the 100-patient evaluable population, which
was the pre-defined primary endpoint, increased from 29% (placebo) to 47%
(talactoferrin) (one-tailed p-value = 0.05), meeting the pre-specified level of
statistical significance for the primary endpoint. The evaluable population was
defined as patients who received at least one dose of study drug and had at
least one CT scan after the start of treatment, which is necessary to determine
a response rate. The response rate in the 110-patient intent-to-treat
population increased from 27% to 42% (one-tailed p=0.08). The maximum duration
of treatment with talactoferrin or placebo was 18 weeks, as treatment was
stopped at the same time treatment with carboplatin/paclitaxel was discontinued,
even in the absence of disease progression. Median progression-free survival,
overall survival, and duration of response were also longer in the talactoferrin
arm, although the differences were not statistically significant.

In the study, talactoferrin appeared to be well tolerated. Patients who
received talactoferrin had fewer total adverse events (two-tailed p=0.003),
grade 3 or 4 adverse events (p=0.05), adverse events related to study drug or
chemotherapy, incidence of serious adverse events, and discontinuations due to
adverse events. The most frequently reported adverse events occurred at
comparable rates in the two arms and were consistent with those typically
observed in NSCLC patients undergoing chemotherapy, including myelotoxicity
(affecting bone marrow), gastrointestinal disorders, respiratory disorders and
alopecia (hair loss).

About talactoferrin
Talactoferrin 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 promising activity in randomized,
double-blind, placebo-controlled Phase II studies in NSCLC and in severe sepsis.
Two Phase III trials with talactoferrin in NSCLC are ongoing. The FORTIS-M
trial, which completed enrollment in March 2011, is evaluating talactoferrin in
NSCLC patients whose disease has progressed following two or more prior
treatment regimens. 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.
Agennix is also continuing the development of talactoferrin 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 and in severe
sepsis. Talactoferrin is currently in Phase III clinical trials in non-small
cell lung cancer, and Agennix is also continuing the development of this program
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.

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. 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, they may not be
sufficient to gain marketing approval in the United States or any other country,
and the 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. 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(TM) is a trademark of the Agennix group.

Further inquiry note:
Agennix AG
Barbara Mueller
Manager, Investor Relations & Corporate Communications
Tel.: +49 89 8565-2693
[email protected]

In the USA: Laurie Doyle
Senior Director, Investor Relations & Corporate Communications
Tel.: 609-524-5884
[email protected]

Additional media contact for Europe:
MC Services AG
Raimund Gabriel
Tel.: +49 89 210 228 0
[email protected]

Additional investor contact for Europe:
Trout International LLC
Lauren Williams, Vice President
Tel.: +44 207 936 9325
[email protected]
end of announcement euro adhoc
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company: AGENNIX AG
Im Neuenheimer Feld 515
D-69120 Heidelberg
phone: +49 89 8565 2693
FAX: +49 89 8565 2610
mail: [email protected]
WWW: http://www.agennix.com
sector: Pharmaceuticals
ISIN: DE000A1A6XX4
indexes: CDAX, Prime All Share, Technology All Share
stockmarkets: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Hamburg, Düsseldorf, Hannover, München
language: English

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