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Lupus trial to expand to U.S.
June 2016
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PARIS & BOSTON—The U.S. Food and Drug Administration (FDA) has granted IND approval to Neovacs to extend its ongoing Phase 2b clinical trial of IFNα Kinoid for the treatment of lupus to the United States. The study is a worldwide multi-centric, randomized study to assess the biological and clinical efficacy of the IFNα Kinoid in patients with moderate to severe lupus. The trial will run 18 months and consist of 178 patients, with full Phase 2b results expected in mid-2017.
 
“This clearance by the FDA is a real success for Neovacs and will allow us to extend our actual trial to American investigators and patients. The FDA has given this approval within the regulatory time frame, which demonstrates the complete and convincing character of our file. Important investigating centers—notably in New York, Oklahoma and Miami—have been waiting for this authorization to set up the trial. Therefore, the recruitment of patients will start very soon,” remarked Neovacs CEO Miguel Sieler.

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