HENNIGSDORF--(Marketwire - May 18, 2010) - Revotar Biopharmaceuticals AG / Revotar presents positive results in Phase IIa Ozone Study with Bimosiamose for COPD processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
The encouraging data support further development of the new pan selectin antagonist in COPD
BERLIN/Hennigsdorf (Germany), May 18, 2010 - Revotar Biopharmaceuticals AG today announced first positive results on a Phase IIa study conducted to evaluate the effect of Bimosiamose on ozone-induced airway inflammation in healthy subjects with a new controlled breathing nebulizer device.
Inhaled ozone in combination with physical exercise is an established standardized method to induce in healthy volunteers a reversible airway inflammation characterized by a cellular infiltrate and cytokines quantifiable in induced sputum. This is an accepted clinical model for the investigation of new anti-inflammatory therapies in chronic obstructive pulmonary disease (COPD).
The trial conducted at two centers in Germany was designed as a double-blind, placebo controlled, randomized cross-over study comprising 18 non-smoking healthy ozone-responsive volunteers. Each subject received nebulized Bimosiamose solution or vehicle for four consecutive days twice daily in two subsequent periods separated by a wash-out phase (cross-over). Treatment was followed by ozone challenge and subsequent collection of induced sputum that was analyzed for cellular composition and non-cellular mediators.
Inhalation of Bimosiamose with a new controlled breathing nebulizer device was safe and well tolerated. Compared to placebo, the compound demonstrated a broad and significant anti-inflammatory effect on cellular and non-cellular sputum parameters. Detailed study results will be submitted for publication.
“This trial confirms the anti-inflammatory potential of the inhaled pan-selectin antagonist Bimosiamose in a respiratory setting”, said Prof. Wolfgang Meyer-Sabellek, Chief Medical Officer of Revotar. “It is in line with previous exploratory data and clearly supports the planned clinical development of Bimosiamose in COPD and other respiratory indications such as acute lung injury and asthma.”
“There is a huge market need for efficacious and safe anti-inflammatory treatments in COPD”, added Dr. Martin Pohlchen, CEO of Revotar. “Encouraged by the results of this study two Phase II Proof-of-concept-studies in COPD patients are planned in order to proof and translate the anti-inflammatory effect of Bimosiamose into a clinical benefit in patients with COPD”.
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 Biopharmaceuticals 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 Pohlchen, 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#1416748] Revotar Biopharmaceuticals AG Neuendorfstr. 24a Hennigsdorf Germany
Press Release (PDF): http://hugin.info/143207/R/1416748/367301.pdf
