Mediwound applies to FDA for burns treatment Phase III trial

150 patients with second and third degree burns will be recruited for the trial, which will be conducted at medical centers in the US, Europe, and other countries.

Biotechnology company Mediwound Ltd. has applied to the US Food and Drug Administration (FDA) to conduct a Phase III clinical trial of its NexoBrid treatment for the debriding of burn wounds.

The trial will test the effectiveness and safety of the treatment compared with the control group. 150 patients with second and third degree burns will be recruited for the trial, which will be conducted at dozens of medical centers in the US, Europe, and other countries.

On the basis of Mediwound's Phase III clinical trital of NexoBrid in Europe, it filed a registration application for the treatment with the European Medicines Agency (EMEA) in October 2010.

Clal Biotechnology Industries Ltd. (TASE: CBI), the life sciences investment arm of Nochi Dankner-controlled IDB Holding Corp. Ltd. (TASE:IDBH), owns 52% of Mediwound. Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) is also an investor.

Published by Globes [online], Israel business news - www.globes-online.com - on May 1, 2011

© Copyright of Globes Publisher Itonut (1983) Ltd. 2011

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