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Welichem Files Phase II Trial Application For WBI-1001 With Health Canada

PBR Staff Writer Published 30 September 2009

Drug intented for treatment of chronic atopic dermatitis

Welichem Biotech has announced the filing with Health Canada of a clinical trial application for its lead, anti-inflammatory drug WBI-1001. The application is for a 3-month, double blinded clinical trial in patients with chronic atopic dermatitis at three trial centres.

The filing is a direct result of the successful completion of the long-term, IND-enabling toxicology studies announced April, 2009. Results of the long-term toxicology studies support additional, longer term clinical trials of WBI-1001.

The company said that Welichem's plans for the international phase II/III clinical program as it builds on the successfully completed clinical trials and safety studies of WBI-1001.

WBI-1001 is a non-steroidal, anti-inflammatory drug candidate that has been shown in prior clinical trials to be effective and to have good safety profile. WBI-1001 is a novel, patented drug candidate that is being developed by Welichem as a new treatment for AD, psoriasis and related diseases.

Genhui Chen, chief executive officer of Welichem Biotech, said: "We are very encouraged by the data on this non-steroidal, anti-inflammatory drug candidate. This application is a significant step forward in our drug development program."

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