Revotar Reports Positive Preclinical Data From a 4-month Dermal Toxicity Study
BERLIN/Hennigsdorf, GERMANY, October 28, 2008- Revotar Biopharmaceuticals AG today announced preclinical data from a dermal toxicity study demonstrating that topical administration of Bimosiamose cream in minipigs was safe and well tolerated. Bimosiamose cream (1%, 3%, and 5%) was applied twice daily for 4 months on the skin (10% of total body surface area) of Gottingen minipigs to evaluate the local and systemic toxicity of the test article. The minipig was selected as non-rodent species for this vehicle-controlled chronic dermal toxicity study, as the skin of the pig is very similar to that of humans and the pig is generally accepted as an appropriate model for topical agent testing. "No adverse test article-related effects were observed, and we recorded only a low systemic exposure to Bimosiamose," said Dr Daniel Bock, Director of Preclinical & Clinical R&D at Revotar. "The outcome of this study and the recent Phase I data therefore are a valuable prerequisite for Revotar to proceed with its planned clinical trials in psoriatic patients." Monitoring included macroscopic or microscopic evaluations, clinical observations, dermal irritation scoring, hematology, coagulation, clinical chemistry, ophthalmology, electrocardiography, and body and organ weights. Already, Bimosiamose has been tested successfully in various indications (psoriasis, asthma, and chronic-obstructive pulmonary disease) in Phase I and Phase IIa trials. "The results of this preclinical minipig study will also serve as a basis for further regulatory development in the important US market in parallel to the European markets," added Dr Wolfgang Meyer-Sabellek, Chief Medical Officer of Revotar. Revotar will present itself during the BioInvestor Forum in San Francisco during October 29-31, 2008.
About Revotar Biopharmaceuticals AG Revotar develops innovative drugs for inflammatory indications such as psoriasis, chronic obstructive pulmonary disease (COPD) and acute lung injury (ALI). 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 nearly 200 patients and volunteers. In summer 2006, Revotar announced a Start-Up Development Agreement with a US Pharma company for the further development of Bimosiamose in one major disease area. In September 2008, Revotar announced the successful first closing of its Series A financing round of 5.3 million EUR, with an additional commitment of 3 million EUR based on certain preconditions to be met. Contact Address: 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
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Posted: October 2008
