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FDA Approves Penecure Investigational New Drug Application

TORONTO, July 19 /CNW/ - The U.S. Food and Drug Administration has approved an Investigational New Drug (IND) application from Dimethaid Research Inc. (TSX: DMX) for the company's antifungal treatment Penecure(TM). The approval covers the product's recently announced Phase I/II trial as the first step in a full drug development plan also reviewed by the FDA.

Penecure targets onychomycosis, a common nail fungus disease that affects up to 13 percent of the population and represents a market estimated to be worth $1 billion in the U.S. Although the seven-month, double-blinded, trial focuses on dose-ranging and safety, Dimethaid also expects to identify initial efficacy trends.

"FDA involvement at this early stage is important," said Rebecca E. Keeler, president and CEO. "It lends extra credibility to our clinical trial protocol and lays the groundwork for future clinical trials in the U.S. market."

The first study will be conducted by four clinical investigators, all specialists in dermatology, at sites in southern Ontario. The protocol calls for approximately 90 patients between the ages of 18 and 85, diagnosed with distal subungual onychomycosis in at least one greater toenail.

Penecure takes advantage of Dimethaid's proprietary transcellular technology designed to minimize exposure to active drug and significantly lower the risk of side effects.

The new product has already passed a proof-of-concept study at the University of California, as well as laboratory dose-ranging and accelerated stability studies. Unlike current antifungal lacquers, Penecure has demonstrated an ability to deliver clinically therapeutic levels of active drug through nails, directly targeting the disease site.

Source: Dimethaid Research

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