EANS-News: AGENNIX AG Reports Additional Talactoferrin Alfa Data
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Research & Development
Planegg/Munich and Princeton, NJ (euro adhoc) - Agennix AG (Frankfurt Stock
Exchange: AGX) today announced results from several clinical studies evaluating
talactoferrin alfa (talactoferrin).
FORTIS-C Phase III trial with talactoferrin in first-line non-small cell lung
cancer closed early and unblinded; top-line results announced
As previously announced, following the negative results of the FORTIS-M Phase
III trial evaluating talactoferrin in non-small cell lung cancer (NSCLC)
patients whose disease had progressed following two or more prior treatment
regimens, Agennix made the decision to stop enrollment and analyze the results
from the FORTIS-C Phase III trial. This trial evaluated talactoferrin in
combination with a standard chemotherapy regimen, carboplatin plus paclitaxel,
compared to placebo plus carboplatin and paclitaxel in first-line NSCLC patients
with advanced or metastatic disease (patients who have not yet been treated for
their disease). At the time the FORTIS-C trial was stopped, 94 of the planned
1,100 patients had been enrolled and received study drug; all patients were
enrolled at five U.S. sites. The study had co-primary endpoints of
progression-free survival (PFS) and overall survival (OS).
Investigator-reported median PFS in the talactoferrin arm was 5.8 months
compared to 5.6 months for placebo(hazard ratio 0.97, p-value 0.89). Median OS
in the talactoferrin arm was 11.4 months compared to 12.7 months for placebo
(hazard ratio 1.25, p-value 0.36). The nature and incidence of adverse events in
the talactoferrin arm were similar to that of placebo.
Final data reported in Phase I/II study evaluating talactoferrin's potential to
prevent nosocomial infections in pre-term infants
The Company also reported final data from a Phase I/II randomized, placebo-
controlled trial, funded by a U.S. National Institutes of Health (NIH) grant,
evaluating talactoferrin's potential to reduce the incidence of nosocomial
(hospital acquired) infections in infants born prematurely, which was the
primary endpoint. The study enrolled a total of 120 patients. Ten percent of
patients (6 of 60) in the talactoferrin arm developed nosocomial infections
compared to fifteen percent (9 of 60) in the placebo arm. This difference,
while in favor of talactoferrin, was not statistically significant. The nature
and incidence of adverse events in the talactoferrin arm were generally similar
to that of placebo and consistent with expectations for the population under
study.
Final data from halted OASIS Phase II/III trial in severe sepsis presented at
ISF Sepsis 2012
Final data from the halted OASIS Phase II/III trial evaluating talactoferrin in
adult patients with severe sepsis were presented in November at the
International Sepsis Forum Sepsis 2012 meeting. Data presented included 28-day
and three-month all-cause mortality. As previously reported, talactoferrin did
not improve 28-day all-cause mortality, the primary endpoint of the study, nor
did it improve mortality at three months. The most commonly reported adverse
events in the study were in line with those that generally occur with sepsis
patients in the intensive care unit and were generally similar between placebo
and talactoferrin.
Rajesh Malik, M.D., Chief Medical Officer, said: "We have performed extensive
analyses of the talactoferrin program to determine if there is a potential
explanation for the outcomes of recent clinical trials compared to earlier
promising results. If the hypotheses generated from these analyses can be
confirmed by additional research, a new development path forward for
talactoferrin may be considered. We will further update the market as soon as
we are in a position to do so."
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 clinical development programs include oral talactoferrin
alfa; a topical gel form of talactoferrin and RGB-286638, a multi-targeted
kinase inhibitor. Agennix's registered seat is in Heidelberg, Germany. The
Company has two sites of operation: Planegg/Munich, Germany and Princeton, New
Jersey. 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 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 clinical studies will be successful.
There can be no guarantee that the Company will have or be able to obtain the
financial resources to conduct additional studies with its product candidates or
that it will be successful in pursuing a strategic transaction. 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:
Agennix AG
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
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
indexes: CDAX, Prime All Share, Technology All Share
stockmarkets: free trade: Hannover, Berlin, München, Hamburg, Düsseldorf,
regulated dealing/prime standard: Frankfurt
language: English