EANS-News: Agennix Announces Data from Talactoferrin Phase II Trial in Non-Small
Cell Lung Cancer Published in Journal of Clinical Oncology
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Research & Development
Planegg/Munich (Germany), Princeton, NJ and Houston, TX (euro adhoc) - October
11, 2011 - Agennix AG (Frankfurt Stock Exchange: AGX) today announced that data
from a Phase II randomized, double-blind, placebo-controlled clinical trial
evaluating the oral immunotherapy, talactoferrin, in patients with previously
treated non-small cell lung cancer (NSCLC) have been published in the
peer-reviewed medical journal, Journal of Clinical Oncology. The article, "A
Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oral
Talactoferrin in Patients with Locally Advanced or Metastatic Non-Small Cell
Lung Cancer that Progressed Following Chemotherapy," by P. Parikh et al, will
appear in the November 1, 2011 print issue of the journal. As previously
reported, this study, conducted in patients with NSCLC for whom one or more
prior lines of anti-cancer therapy had failed, achieved its primary endpoint of
improvement in overall survival. Talactoferrin also appeared to improve survival
across a broad range of patient subsets, including those with squamous and
non-squamous histologies, as well as other important prognostic factors. The
results of this study served as the basis for the ongoing talactoferrin Phase
III FORTIS-M trial, which is being conducted in patients whose disease has
progressed following two or more prior treatment regimens. The FORTIS-M study
has completed enrollment and topline results are expected in the first half of
2012.
"There is a major need for effective, easy-to-use, well tolerated treatments for
patients with refractory non-small cell lung cancer," said Rajesh Malik, M.D.,
Chief Medical Officer. "The promising results from this study show the
potential of talactoferrin to improve survival where previous therapies have
failed, including effects across a broad range of clinically important subsets.
Talactoferrin appears to provide anti-tumor activity without many of the common
toxicities associated with other treatments for non-small cell lung cancer. In
addition, talactoferrin is an oral liquid that offers convenience for both
patients and physicians to use. We look forward to reporting topline results
from our ongoing Phase III FORTIS-M registration trial in advanced non-small
cell lung cancer in the first half of 2012."
The published randomized Phase II trial enrolled 100 patients with stage IIIB/IV
non-small cell lung cancer whose disease had progressed following one or more
lines of anti-cancer therapy and evaluated the use of talactoferrin plus best
supportive care compared to placebo plus best supportive care. The results
showed that talactoferrin improved median overall survival by 65% compared to
placebo [6.1 months versus 3.7 months, hazard ratio = 0.68, 90% Confidence
Interval: 0.47-0.98, p=0.04 (one-tailed log-rank test)], meeting the
protocol-defined level of statistical significance. The six-month overall
survival rate was 30% in the placebo arm and 52% in the talactoferrin arm. The
one-year overall survival rate was 16% in the placebo arm compared to 29% in the
talactoferrin arm. Supportive results were seen in the secondary endpoints of
progression-free survival and disease control rate. The above analyses were
conducted on an intent-to-treat basis.
Talactoferrin was shown to be very well tolerated in this study, with fewer
adverse events compared to placebo. The most frequently reported severe (grade
3 or greater) adverse event was dyspnea (labored breathing), which occurred in
15% of patients in the talactoferrin arm and 26% in the control arm. There were
no serious adverse events considered to be related to treatment with
talactoferrin.
About talactoferrin
Talactoferrin is an oral immunotherapy that 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 developing talactoferrin for the treatment of severe sepsis and
has initiated a Phase II/III trial, called the OASIS 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 immunotherapy 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 a Phase II/III trial with talactoferrin in severe sepsis
is underway. 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. 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.
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.
Further inquiry note:
Agennix AG
Barbara Mueller
Manager, Investor Relations & Corporate Communications
Tel.: +49 89 8565-2693
ir@agennix.com
In the U.S.: Laurie Doyle
Senior Director, Investor Relations & Corporate Communications
Tel.: 609-524-5884
laurie.doyle@agennix.com
Additional media contact for Europe:
MC Services AG
Raimund Gabriel
Tel.: +49 89 210 228 0
raimund.gabriel@mc-services.eu
Additional investor contact for Europe:
Trout International LLC
Lauren Williams, Vice President
Tel.: +44 207 936 9325
lwilliams@troutgroup.com
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: ir@agennix.com
WWW: http://www.agennix.com
sector: Pharmaceuticals
ISIN: DE000A1A6XX4
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