Revotar Biopharmaceuticals AG Starts Phase II Clinical Trial in COPD Patients with inhaled Bimosiamose
Revotar Biopharmaceuticals AG / Revotar Biopharmaceuticals AG Starts Phase II Clinical Trial in COPD Patients with inhaled Bimosiamose processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
BERLIN/Hennigsdorf (Germany), June 10, 2010 - Revotar Biopharmaceuticals AG
today announced the start of a Phase II study to evaluate the safety and
efficacy of inhaled Bimosiamose, a pan-selectin antagonist, for the treatment of
patients with chronic obstructive pulmonary disease (COPD).
The trial is designed as a double-blind, placebo controlled, randomized,
cross-over study comprising up to 60 non-smoking patients with moderate to
severe COPD (GOLD II-III). Each subject will receive nebulized Bimosiamose
solution or vehicle for 28 consecutive days twice daily in two subsequent
periods according to a randomization plan and separated by a wash-out phase
(cross-over). Co-alternative primary endpoints will be the difference of
neutrophils counts and interleukin-8 levels in induced sputum following
Bimosiamose and Placebo; secondary variables cover lung function parameters as
well as cellular and non-cellular biomarkers. The study is conducted at 10
centers in Germany.
"Inhaled Bimosiamose solution previously demonstrated to be safe and
anti-inflammatory in short-term trials with healthy subjects (ozone challenge)
and in patients with Asthma and COPD," said Prof Wolfgang Meyer-Sabellek, Chief
Medical Officer of Revotar. "We are now looking forward to confirm and extend
this encouraging potential on the basis of longer treatment and more COPD
outpatients."
"There is a huge market need for efficacious and safe anti-inflammatory drugs in
COPD considering the reported limited efficacy of inhaled corticosteroids (ICS)
or even documented ICS resistance in COPD", added Dr Martin Pöhlchen, CEO of
Revotar.
In contrast to oral PDE4 inhibitors, Bimosiamose is given locally by inhalation,
directly targeting the inflammation in the lung. In recent assessments from
regulatory authorities (e.g. IQWiG) inhalative treatment is preferred towards
oral treatment in COPD, since better efficacy and faster onset may be achieved
with less systemic side effects. Results are expected for the second quarter of
2011."
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), asthma and
psoriasis. Its lead candidate Bimosiamose, a pan-selectin antagonist, has
already passed several clinical phase I and phase IIa trials in asthma, COPD 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.
Contact:
Dr. Martin Pöhlchen, CEO
Revotar Biopharmaceuticals AG
Neuendorfstr. 24a
D-16761 Hennigsdorf / Germany
Phone: +49 3302 2025010
Fax: +49 3302 2025030
Email:info@revotar-ag.de
www.revotar.de
[HUG#1422847]
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Revotar Biopharmaceuticals AG
Neuendorfstr. 24a Hennigsdorf Germany
Press Release (PDF): http://hugin.info/143207/R/1422847/371866.pdf
