Go ahead for A-Virals first human study in Europe
Therapy of inflammatory diseases, autoimmune diseases or tissue rejection
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A-Virals first human study in Europe is approved by the Ethics Committee at The Academical Medical Centre, Amsterdam. The study will be carried out under the supervision of Professor Dr. Med. Tom van der Poll at AMC, which is one of Amsterdam's larger hospitals, and also one of the city's largest medical research centres.
Having passed the Ethics Committee, only the formal approval from AMC remains before they can start screening volunteers for testing. Insurance is already paid. We expect the study to start in about 2 weeks, and all data should be in by week 2 in 2004. A-Viral will thereafter receive a report, probably in February.
The study approved is a phase 2 double blind study with 16 volunteers who will all receive an injection with LPS which will provoke an immune reaction for a few hours, the symptoms are much like a strong flu. Two hours prior to the LPS injection, half the patients will receive AV 1101, and the other half will receive placebo. Before and under the study, blood samples from the patients will be taken, and numerous relevant parameters will be checked, to see in which way AV 1101 influence the immune response. Blood from patients will also be tested ex vivo. And general parameters like fever, headache, etc will be observed systematically.
This type of study has been successfully carried out for numerous anti-inflammatory drugs. The protocol is well known and acknowledged as a good method for gathering information about new drugs. The study will give good indications for which direction we should go in our next study.
The following persons are involved in the study, the protocol and/or the analysis.
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