Xendo conducts human microdosing (human phase 0) study for Biofrontera AG
From: http://www.biofrontera.com
First human study with Biofrontera’s migraine prophylaxis product
Leverkusen, Germany, 20NOV2006 - Biofrontera AG today announced that the responsible local Authority and the Ethical Committee have approved the first study in humans of Biofrontera’s drug candidate BF-1. Biofrontera develops BF-1 for the prophylactic treatment of severe migraine. The clinical trial represents the first application of the compound to human volunteers.
The trial is supervised by Xceleron Inc., York, England and will be performed by Xendo Drug Development BV in the Netherlands. The goal of the study is to assess the rate at which applied BF-1 enters the blood stream, how long it will be present in the blood and to which extent it will be degraded before elimination. Provided that the enrollment of test persons will proceed as planned, Biofrontera expects preliminary results by the end of the year.
BF-1 is the leading product of Biofrontera’s maturing preclinical product portfolio of anti-inflammatory drugs which acts as a highly selective and potent 5-HT2B receptor inhibitor.
"We believe that the medical need for the prophylaxis of migraine is enormous. We expect BF-1 to be effective in migraine prophylaxis without any relevant adverse side effects. Our hope is that this initial clinical trial will provide information that is relevant for the strategic planning of the further development." commented Dr. Reinhold Gahlmann, Biofrontera's Head of Drug Development.
Migraines are acute, periodically occurring attacks of very severe headache, usually affecting only one side of the head and often accompanied by nausea and vomiting. It is estimated that approximately 10-12% of the population in industrialized countries suffers from migraine attacks. Biofrontera believes that prophylactic treatment is indicated for the 10-20% of the patients with frequent attacks.
Original Press Release Biofrontera AG
Human microdosing (Human Phase 0) is a new concept which relies on the ultrasensitivity of accelerator mass spectrometry (AMS). To find out more on human microdosing go to:
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