Agennix AG Announces Longer-Term Mortality Results from Talactoferrin Phase 2 Trial in Severe Sepsis
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Agennix AG / Agennix AG Announces Longer-Term Mortality Results from Talactoferrin Phase 2 Trial in Severe Sepsis processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Trial results show effect of talactoferrin on reduction in mortality is
sustained at three months and six months
Martinsried/Munich (Germany), Princeton, NJ and Houston, TX, February 26, 2010 -
Agennix AG (Frankfurt Stock Exchange: AGX) today announced longer-term mortality
results from the talactoferrin randomized, double-blind, placebo-controlled
Phase 2 trial in severe sepsis. The trial evaluated talactoferrin versus placebo
in 190 adult patients with severe sepsis enrolled at 25 leading centers across
the U.S. Patients in both arms received standard of care treatment for severe
sepsis in an intensive care unit (ICU) setting. As previously reported, the
trial achieved its primary endpoint of a reduction in 28-day all-cause
mortality. The results announced today showed that talactoferrin also reduced
all-cause mortality compared to placebo over the longer term - at three months
and at six months.
Three-month all-cause mortality was 29.3% in the placebo arm compared to 18.1%
in the talactoferrin arm, an absolute reduction of 11% and relative reduction of
38% (unadjusted two-tailed p-value = 0.07, odds ratio by logistic regression
analysis = 0.53). When the results were adjusted for cardiovascular dysfunction,
a major prognostic factor for severe sepsis, the two-tailed p-value was 0.09,
and the odds ratio was 0.55.
At six months, there was a statistically significant reduction in all-cause
mortality from 35.2% in the placebo arm to 21.3% in the talactoferrin arm, an
absolute reduction of 14% and relative reduction of 39% (unadjusted two-tailed
p-value = 0.04, odds ratio = 0.50; adjusted two-tailed p-value = 0.05, odds
ratio = 0.51). The absolute reduction in six-month all-cause mortality of 14%
was greater than the absolute reduction seen in 28-day all-cause mortality
(which was 12%, from 26.6% in the placebo arm to 14.6% in the talactoferrin
arm).
The results for three- and six-month all-cause mortality in the study were
consistent and sustained for patients with and without cardiovascular
dysfunction.
"We are extremely pleased to see that the treatment effect of talactoferrin in
severe sepsis appears to be sustained over a longer time period," said Rajesh
Malik, M.D., Chief Medical Officer. "There are currently very limited treatment
options available, with only one drug approved specifically for severe sepsis, a
disease that results in hundreds of thousands of deaths each year in the U.S.
and Europe alone. We plan to meet with regulatory authorities within the next
few months to discuss plans for advancing talactoferrin for this indication."
The above analyses were all conducted on an intent-to-treat (ITT) as-treated
basis, meaning that patients were evaluated based on the treatment they actually
received (talactoferrin or placebo).
Talactoferrin was shown to be very well tolerated in the study with no major
differences in adverse events between the two treatment arms.
The Phase 2 trial was primarily funded by a grant from the U.S. National
Institutes of Health.
The Company plans to present data from the trial at an upcoming major medical
meeting.
About severe sepsis
Sepsis is a condition involving known or suspected infection and generalized
inflammation. The body's normal response to an infection is to set off a limited
chain reaction to fight the infection. In severe sepsis, this systemic response
escalates into an overreaction by the body that leads to dysfunction of one or
more organs. Each year, approximately 750,000 people in the U.S. alone develop
severe sepsis, and a similar number of people are affected in Europe. Those
figures are expected to rise due to the aging population and other factors.
Approximately 30-40% of people with severe sepsis are estimated to die annually
from this condition in the U.S., and the U.S. Centers for Disease Control and
Prevention indicates that sepsis is one of the top ten leading causes of death
in the U.S.
About oral talactoferrin
Talactoferrin is an oral novel targeted dendritic cell recruiter and activator
being studied mainly for the treatment of cancer and severe sepsis.
Talactoferrin has demonstrated activity in randomized, double-blind,
placebo-controlled Phase 2 studies in non-small cell lung cancer (NSCLC) as well
as in severe sepsis. As a result of the promising results from Phase 2 NSCLC
studies, two Phase 3 studies have been initiated with talactoferrin in NSCLC.
The Company is planning to meet with regulatory authorities to discuss a plan
for the further development of talactoferrin for the treatment of severe sepsis.
Talactoferrin has been shown to be very well tolerated in these patient
populations.
About Agennix
Agennix AG is a publicly traded biopharmaceutical company that is developing
novel therapies in areas of major unmet medical need to improve the length and
quality of life of seriously ill patients. The Company's most advanced program
is talactoferrin, an oral targeted therapy that has demonstrated activity in
randomized, double-blind, placebo-controlled Phase 2 studies in non-small cell
lung cancer as well as in severe sepsis. Talactoferrin is currently in Phase 3
clinical trials in non-small cell lung cancer. Other clinical development
programs include RGB-286638, a multi-targeted kinase inhibitor in Phase 1
testing; the oral platinum-based compound satraplatin; 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:
Martinsried/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. There can be no guarantee that the Company will move talactoferrin
forward in development for severe sepsis in a timely manner, if at all, or that
talactoferrin will ultimately be approved for sale in any country. 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. 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.
For further information, please contact:
Agennix
AG
Investor Relations & Corporate Communications
Phone: +49 (0)89
8565 2693
ir(at)agennix.com
In the U.S.: Laurie
Doyle
Director, Investor Relations & Corporate Communications
Phone: +1 609 524 5884
laurie.doyle(at)agennix.com
Additional media contacts for Europe:
MC Services
AG
Phone: +49 (0) 89 210 228 0
Raimund
Gabriel
raimund.gabriel(at)mc-services.eu
Hilda
Juhasz
hilda.juhasz(at)mc-services.eu
Additional investor contact for Europe:
Trout International
LLC
Lauren Williams, Vice President
Phone: +44 207 936 9325
lwilliams(at)troutgroup.com
[HUG#1388902]
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Datum: 26.02.2010 - 02:29 Uhr
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