Agennix AG Announces Presentation of New Data from Talactoferrin Randomized, Double-Blind, Placebo-Controlled Phase II Trial in Severe Sepsis at American Thoracic Society International Conference
(Thomson Reuters ONE) -
Agennix AG / Agennix AG Announces Presentation of New Data from Talactoferrin Randomized, Double-Blind, Placebo-Controlled Phase II Trial in Severe Sepsis at American Thoracic Society International Conference processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Agennix AG Announces Presentation of New Data from Talactoferrin Randomized,
Double-Blind, Placebo-Controlled Phase II Trial in
Severe Sepsis at American Thoracic Society International Conference
* Results show talactoferrin reduces 28-day all-cause mortality across wide
range of baseline prognostic factors, including APACHE II score
* Results show no significant differences in adverse events for talactoferrin
compared to placebo
Martinsried/Munich (Germany), Princeton, NJ and Houston, TX, May 17, 2010 -
Agennix AG (Frankfurt Stock Exchange: AGX) today announced the presentation of
promising new activity and safety data from a Phase II trial with talactoferrin
in severe sepsis at the International Conference of the American Thoracic
Society in New Orleans, Louisiana. The double-blind, placebo-controlled 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 also
received standard of care treatment for severe sepsis in an intensive care unit
(ICU) setting. The data presented today show that talactoferrin reduced 28-day
all-cause mortality in the overall population by 12% compared to placebo (45%
relative reduction) and appeared to show an effect across a broad range of
baseline characteristics, including APACHE II score, cardiovascular dysfunction
and the number and type of organ dysfunctions, all of which are important
prognostic factors for severe sepsis. The results showed that talactoferrin
also reduced all-cause mortality compared to placebo over the longer term - at
three months and at six months.
Kalpalatha Guntupalli, M.D., Professor and Chief, Pulmonary Critical Care and
Sleep Medicine, Baylor College of Medicine and principal investigator of the
talactoferrin Phase II trial, said: "There are currently limited treatment
options for patients with severe sepsis, a condition that is very challenging to
treat and for which the mortality rate is approximately 30-40%. This study
demonstrates that talactoferrin has the potential to have a major impact on
reducing mortality in patients with severe sepsis and that this improvement
appears to be consistent regardless of APACHE II baseline score. Talactoferrin
was also shown to be well tolerated in this very sick patient population."
Rajesh Malik, M.D., Chief Medical Officer of Agennix AG, said: "We are very
excited about the data presented today from our Phase II trial with
talactoferrin in severe sepsis. Once we have met with regulatory authorities to
discuss these data and our plans, we look forward to advancing the development
of talactoferrin for this indication."
The Phase II trial achieved its primary endpoint of a reduction in 28-day
all-cause mortality from 26.6% in the placebo arm to 14.6% in the talactoferrin
arm (two-tailed unadjusted p-value = 0.04, odds ratio by logistic regression
analysis = 0.47), as previously disclosed. Patients were stratified by clinical
site and by the presence or absence of cardiovascular dysfunction due to sepsis.
When the trial results were adjusted for cardiovascular dysfunction, the
two-tailed p-value was 0.06, and the odds ratio was 0.49.
Sixty-four percent (64%) of patients (n=121) in the trial had cardiovascular
dysfunction due to sepsis and 36% (n=69) did not at baseline. For those
patients with cardiovascular dysfunction, talactoferrin showed a relative
reduction in 28-day all-cause mortality of 22% (28.6% for the placebo arm versus
22.4% for the talactoferrin arm). For patients who did not have cardiovascular
dysfunction, talactoferrin showed a relative reduction in 28-day all-cause
mortality of 88% (22.6% for placebo vs. 2.6% in the talactoferrin arm).
Talactoferrin showed a trend toward a decrease in 28-day all-cause mortality
across all baseline APACHE II score quartiles. In patients with APACHE II
scores of 0-18, talactoferrin reduced mortality by 56% (8.7% for placebo vs.
3.8% for talactoferrin); in patients with APACHE II scores of 19-23,
talactoferrin reduced mortality by 44% (13.8% for placebo vs. 7.7% for
talactoferrin); in patients with APACHE II scores between 24-27, talactoferrin
reduced mortality by 50% (33.3% for placebo vs. 16.7% for talactoferrin) and in
patients with scores greater than 27, the sickest patient group, mortality was
reduced by 42% (60% for placebo vs. 35% for talactoferrin).
In addition, talactoferrin reduced mortality in patients with different numbers
and types of organ dysfunctions at baseline. For patients with three or less
organ dysfunctions at baseline (89% of enrolled patients), there was a
statistically significant 53% reduction in mortality from 24.4% for placebo
versus 11.4% for talactoferrin (two-tailed p-value by Fisher's Exact test =
0.03).
Talactoferrin was very well tolerated in the study with no significant
differences in adverse events between the two treatment arms. Of those adverse
events considered to be possibly related to treatment, the most frequently
reported category in both treatment groups was gastrointestinal disorders (5.6%
of patients in the talactoferrin arm and 5.3% in the placebo arm). There were
no serious adverse events considered to be related to treatment with
talactoferrin.
The above analyses were all conducted on a modified intent-to-treat basis (also
referred to as intent-to-treat as treated), meaning that patients were evaluated
based on the treatment they actually received (talactoferrin or placebo) during
the first week of treatment. The median number of treatment days was 6.0 for
the talactoferrin group and 4.5 days for placebo.
All patients were centrally screened for eligibility prior to randomization.
The arms were generally well balanced in terms of baseline characteristics.
The Phase II trial was primarily funded by a $3 million grant from the U.S.
National Institutes of Health.
About severe sepsis
Sepsis is a condition involving 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 immune response becomes
overactive and results in damage to vital body organs, leading to a shutdown of
one or more organs and, in many cases, death. Each year, approximately 750,000
people in the U.S. develop severe sepsis, and a similar number of people are
affected in Europe. Due to the aging of the population, this number is expected
to grow over time. An estimated 30-40% of people with severe sepsis are
expected 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. Patients suffering from severe sepsis must
be hospitalized, often in an intensive care unit, and the medical costs to treat
sepsis were estimated in 2001 to be over $16 billion in the U.S. alone, a number
that is believed to have increased significantly over time.
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 activity in randomized,
double-blind, placebo-controlled Phase II studies in non-small cell lung cancer
(NSCLC), as well as in severe sepsis. As a result of the promising results from
Phase II studies, two Phase III studies with talactoferrin in NSCLC have been
initiated. NSCLC is one of the most common types of cancer worldwide and the
most frequent cause of cancer death. Agennix also plans to develop
talactoferrin further 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 focused on the
development of novel therapies to improve the length and quality of life of
seriously 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, as well as in severe sepsis. Talactoferrin is
currently in Phase III clinical trials in non-small cell lung cancer, and
Agennix plans to develop this program further for the treatment of severe
sepsis. 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 (Rigg) Williams, Vice President
Phone: +44 207 936 9325
lwilliams(at)troutgroup.com
[HUG#1416364]
--- End of Message ---
Agennix AG
Im Neuenheimer Feld 515 Heidelberg Germany
ISIN: DE000A1A6XX4;
Listed: Prime Standard in Frankfurter Wertpapierbörse,
Regulierter Markt in Frankfurter Wertpapierbörse;
Datum: 17.05.2010 - 15:14 Uhr
Sprache: Deutsch
News-ID 20992
Anzahl Zeichen: 0
contact information:
Town:
Heidelberg
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 171 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Agennix AG Announces Presentation of New Data from Talactoferrin Randomized, Double-Blind, Placebo-Controlled Phase II Trial in Severe Sepsis at American Thoracic Society International Conference"
steht unter der journalistisch-redaktionellen Verantwortung von
Agennix AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
