Wound care treatment developer Polyheal Ltd. today announced the final results of the Phase IV clinical trial of its leading product, Polyheal-1.
A Phase IV clinical trial is a post-marketing study to gain better understanding of a treatment. The double blind trial included 66 patients with third and fourth-degree chronic wounds at five medical centers in Israel. The patients were divided into two groups, one of which received Polyheal-1 and the other which received a standard treatment (the control group), over a four-week period. The two groups then both received a standard treatment for eight more weeks.
The trial results found that 65% of the patients treated with Polyheal-1 met the primary endpoint - covering of the wound with a granulated layer - compared with 19% of the patients in the control group. After four weeks, the area of the wound was reduced by an average of 40% in patients treated with Polyheal-1, compared with an average of 15% among patients in the control group. The difference persisted at the end of the additional eight-week period.
At the end of the additional eight-week period, twice as many chronic wounds were completely closed in patients treated with Polyheal-1, compared with the patients in the control group.
The analysis of certain sub-groups found that in the subgroup of 24 patients suffering from venous chronic wounds, 73% of the patients treated with Polyheal-1 met the trial's primary endpoint. In the sub-group of 10 patients with severe wounds, such as where the bone was exposed, 73% of the patients treated with Polyheal-1 met the trial's primary endpoint. In both sub-groups, none of the patients in the control group achieved the primary endpoint. At the end of the additional eight-week period, five times as many wounds in these two sub-groups were completely closed, compared with the patients in the control group.
Polyheal’s patented wound management technology uses chemically inert, non-biodegradable, charged synthetic microspheres, to initiate and promote the complex wound healing process, without the need of additional drugs. The company claims that the market for chronic wound treatment is $7 billion annually.
Nochi Dankner-controlled IDB Holding Corp. Ltd. (TASE:IDBH) life sciences investment unit Clal Biotechnology Industries Ltd. (TASE: CBI) owns 40% of Polyheal.
Published by Globes [online], Israel business news - www.globes-online.com - on February 4, 2010
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