MediWound widens scope of Phase III trial

MediWound Ltd., which is developing a gel for the treatment of burns, is adding an additional target to its Phase III clinical trial. The aim is to spread the risk in the trial and strengthen its status in the burns sector should its product reach the market.

So far, MediWound has examined its gel from the point of view of removing burned and superfluous tissues utilizing a precise and efficient chemical method, instead of current surgical techniques.

TheEuropean Medicines Agency a> (EMEA)In order to register the product for marketing, the company must achieve its two defined targets. Skin graft surgery is far more complex and expensive than operations to remove burned tissue and therefore it will be enormously advantageous to Mediwound in the burns treatment market, if it can register the gel for both purposes.

The EMEA has approved MediWound's recruitment of 175 patients, as stipulated in the original protocol, in order to prepare an interim report. If the report contains clear proof of both targets, and assuming that the gel is shown to be safe, MediWound will be exempt from adding patients to the trial. If not, then MediWound will be required to recruit an additional 100 patients, which would prolong the trial by an extra year.

Nochi Dankner's IDB unit Clal Biotechnology Industries Ltd. (TASE: CBI) owns 58% of MediWound.

Published by Globes [online], Israel business news - www.globes-online.com - on January 4, 2009

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