Agennix AG Announces Positive Results with Talactoferrin In
Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial|
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- Trial results show 45% overall reduction in 28-day all
cause mortality with talactoferrin versus placebo
- Talactoferrin again shown to be very well tolerated
- Conference call and webcast scheduled for Wednesday,
December 2 at 9 AM ET/3 PM CET
Martinsried/Munich (Germany), Princeton, NJ and Houston, TX, December
1, 2009 - Agennix AG (Frankfurt Stock Exchange: AGX) today reported
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 also received standard of care treatment for
severe sepsis in an intensive care unit (ICU) setting. The trial
achieved its primary endpoint of a reduction in 28-day all-cause
mortality. The trial showed a 45% reduction in the 28-day all-cause
mortality from 26.6% in the placebo arm to 14.6% in the talactoferrin
arm (two-tailed p-value = 0.04, odds ratio by logistic regression
analysis = 0.47).
"We are very excited to see such compelling results with
talactoferrin in severe sepsis, a life-threatening and notoriously
hard-to-treat disease," said Rajesh Malik, M.D., Chief Medical
Officer. "There are currently very limited treatment options
available, with only one drug in the U.S. approved specifically for
severe sepsis, a disease that results in hundreds of thousands of
deaths each year in the U.S. and Europe alone. Given the strength of
these clinical trial results, we plan to talk with regulatory
authorities, as well as key opinion leaders and potential partners,
about advancing talactoferrin for this indication."
Patients were stratified by clinical site and by the presence or
absence of cardiovascular dysfunction. Cardiovascular dysfunction is
a major prognostic factor for severe sepsis. A similar number of
patients had cardiovascular dysfunction in the two treatment groups.
Sixty-four percent (64%) of patients (n=121) in the trial had
cardiovascular dysfunction and 36% (n=69) did not. For those
patients with cardiovascular dysfunction, 28-day all cause mortality
was 28.6% for the placebo arm and 22.4% for the talactoferrin arm.
For patients who did not have cardiovascular dysfunction, 28-day all
cause mortality was 22.6% in the placebo arm compared to 2.6% in the
talactoferrin arm. When the trial results were adjusted for
cardiovascular dysfunction, the two-tailed p-value was 0.06, and the
odds ratio was 0.49.
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). An ITT
as treated analysis is a method to address patient assignment errors
in a way that mitigates the potential impact on the data analysis of
a trial. In this study, the quality control process identified
errors in drug labeling and randomization during the conduct of the
trial that affected the drug assignment for some patients. That is
why this analysis was used, following feedback from the U.S. Food and
Drug Administration (FDA). To determine if the assignment error had
an impact on the outcome of the trial, as recommended by the FDA, the
Company conducted a sensitivity analysis evaluating 28-day all cause
mortality by excluding 22 patients who mistakenly received both
talactoferrin and placebo. This analysis indicated that there was no
apparent effect of the patient assignment errors on the outcome of
the trial. The sensitivity analysis showed that 28-day all cause
mortality in the placebo arm was 25.9% compared to 15.1% for the
Talactoferrin was shown to be very well tolerated in the study with
no major differences in adverse events between the two treatment
The study included 96 patients in the talactoferrin arm and 94
patients in the placebo arm. In addition, four patients were
randomized but did not receive study drug due to withdrawal prior to
receiving the first dose. All patients were centrally screened for
eligibility prior to randomization. The arms were well balanced in
terms of baseline characteristics.
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
Conference call scheduled
The Company has scheduled a conference call to which participants may
listen via live webcast, accessible through the Agennix Web site at
www.agennix.com or via telephone. A replay will be available on the
Web site following the live event. The call, which will be conducted
in English, will be held on Wednesday, December 2, 2009 at 15:00
CET/9:00 AM ET. The dial-in numbers for the call are as follows:
Participants in Europe: 0049 69 667775756
0044 20 3003 2666
Participants in the U.S.: 1-646 843 4608
Please dial in 10 minutes before the beginning of the call.
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 North America 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% 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. Patients
suffering from severe sepsis must be hospitalized, often in an
intensive care unit, and the medical costs to treat sepsis are
estimated to be over $16 billion annually in the U.S. alone.
Talactoferrin is an oral novel targeted dendritic cell recruiter and
activator being studied mainly for the treatment of cancer.
Talactoferrin has demonstrated anti-cancer activity in two
randomized, double-blind, placebo-controlled Phase 2 studies in
non-small cell lung cancer (NSCLC). NSCLC is one of the most common
types of cancer worldwide and the most frequent cause of cancer
death. As a result of the promising results from Phase 2 studies, two
Phase 3 studies with talactoferrin in NSCLC have been initiated.
Talactoferrin has also shown activity in renal cell carcinoma, as
well as severe sepsis. Talactoferrin has been shown to be very well
tolerated in these patient populations. The Company also has a
topical formulation of talactoferrin for wound healing.
Agennix AG is a publicly traded biopharmaceutical company focused on
developing novel anti-cancer therapies. The Company was formed by the
combination of GPC Biotech AG and Agennix Incorporated. The Company's
most advanced program is talactoferrin, an oral targeted therapy that
is 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 wound
healing. Agennix is a transatlantic company with sites in 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:
Investor Relations & Corporate Communications
Phone: +49 (0)89 8565 2693
In the U.S.: Laurie Doyle
Director, Investor Relations & Corporate Communications
Phone: +1 609 524 5884
Additional media contacts for Europe:
MC Services AG
Phone: +49 (0) 89 210 228 0
Additional investor contact for Europe:
Trout International LLC
Lauren (Rigg) Williams, Vice President
Phone: +44 207 936 9325
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