HENNIGSDORF, GERMANY--(Marketwire - March 04, 2011) -
Revotar Biopharmaceuticals AG /
Revotar Biopharmaceuticals meets primary endpoint in Phase II COPD Study
with
inhaled Bimosiamose
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BERLIN/Hennigsdorf (Germany), March 04, 2011 - Revotar
Biopharmaceuticals AG
today announced positive top-line results on a multi-center Phase II
study to
evaluate the safety and efficacy of inhaled Bimosiamose for the
treatment of
patients with chronic obstructive pulmonary disease (COPD).
In a double-blind, placebo controlled, randomized, cross-over study,
patients
with moderate to severe COPD (GOLD II-III) inhaled Bimosiamose
solution or
vehicle for 28 consecutive days twice daily in two subsequent periods
separated
by a wash-out phase (cross-over). Cellular and non-cellular markers of
induced
sputum collected pre-/post treatment were analyzed. The study, conducted
at 11
specialized centers in Germany, enrolled 77 patients.
Inhalation of Bimosiamose was safe and well tolerated. Dose compliance
recorded
by the employed Akita(2) Apixneb nebulizer (Activaero) was high. On
top of
standard bronchodilator treatment, Bimosiamose showed a broad and
favorable
anti-inflammatory effect, reducing most of the evaluated sputum
markers. In
particular, Interleukin-8 (primary endpoint), a biomarker in COPD
related to
disease severity, was significantly reduced (p < 0.009) in sputum of
Bimosiamose
treated patients at day 28, as compared to placebo. Notably, there was a
trend
on improvement of lung function following inhalation with Bimosiamose.
"This proof of concept study clearly demonstrates that inhaled
Bimosiamose is
attenuating inflammation in patients with COPD," said Prof Wolfgang
Meyer-
Sabellek, Chief Medical Officer of Revotar. "In addition, with trends in
lung
function improvement and a good safety pro data encourage to
proceed
with clinical development translating the anti-inflammatory
potential of
Bimosiamose into significant long-term clinical benefit."
"This study is a major milestone on the way towards the establishment of
pan-
selectin antagonism as a novel therapeutic option in COPD", added Dr
Martin
Pöhlchen, CEO of Revotar. Detailed data will be submitted for
publication in a
peer-reviewed respiratory journal.
About COPD
Chronic Obstructive Pulmonary Disease (COPD) comprises several
serious
conditions affecting the lung. According to the WHO, COPD is affecting more
than
210 million people worldwide, of which about 80 million people suffer
from
moderate to severe forms of the disease. More than 3 million people died of
COPD
in 2005, which corresponds to 5% of all deaths globally. The WHO predicts
that
COPD will become the third leading cause of death worldwide by 2030. In
2009,
the global COPD market recorded sales of approximately 10 billion US-$.
About Revotar Biopharmaceutical AG
Revotar develops innovative drugs for inflammatory indications such as
chronic
obstructive pulmonary disease (COPD), acute lung injury (ALI) and
asthma. Its
lead candidate Bimosiamose, a pan-selectin antagonist, has already
passed
several clinical phase I and phase IIa trials in COPD, asthma, and
psoriasis
with a good safety and efficacy profile in over 300 patients and
volunteers.
Furthermore Revotar has two preclinical programs addressing
respiratory and
other inflammatory diseases.
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Revotar Biopharmaceuticals AG
Neuendorfstr. 24a Hennigsdorf Germany
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Source: Revotar Biopharmaceuticals AG via Thomson Reuters ONE
[HUG#1494541]
Contact Address:
Dr Martin Pohlchen, CEO
Revotar Biopharmaceuticals AG
Neuendorfstr. 24a
D-16761 Hennigsdorf / Germany
Phone: +49-3302-2025010
Fax: +49-3302-2025030
Email: Email Contact