EANS-News: Agennix Initiates Phase II/III OASIS Trial with Talactoferrin in
Severe Sepsis
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Research & Development
Planegg/Munich (Germany), Princeton, NJ and Houston, TX, June 30, 2011 (euro
adhoc) - Agennix AG (Frankfurt Stock Exchange: AGX) today announced that the
first patient has been dosed in the Phase II part of the OASIS (Oral
Talactoferrin in Severe Sepsis) trial, a multicenter, double-blind, randomized
Phase II/III trial evaluating the oral immunotherapy talactoferrin for the
treatment of severe sepsis.
"With over 450,000 people in the U.S. and Europe alone estimated to die from
severe sepsis every year, there is an urgent need for effective and well
tolerated therapies to treat this very sick patient population," said Rajesh
Malik, M.D., Chief Medical Officer. "Building on the promising results from our
earlier Phase II study with talactoferrin in severe sepsis, the OASIS trial
should give us important insight into the potential utility of talactoferrin as
a treatment for this major unmet medical need."
The OASIS trial is evaluating talactoferrin plus standard care compared to
placebo plus standard care in adult patients with severe sepsis. The Phase II
part of the trial is planned to enroll approximately 350 patients at clinical
sites predominantly in Western Europe and North America. The study´s primary
objective is to determine the effect of talactoferrin on 28-day all-cause
mortality. Secondary endpoints include three-month, six-month and twelve-month
all-cause mortality. The study will also evaluate the safety and tolerability
of talactoferrin in this patient population, and data will be collected to
further elucidate the mechanism of action of talactoferrin. Additional
information about the trial can be found at www.clinicaltrials.gov.
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 non-small
cell lung cancer (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. 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
indexes: CDAX, Prime All Share, Technology All Share
stockmarkets: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Hamburg, Düsseldorf, Hannover, München
language: English