<font color=green>Dimethaid receives approval for Penecure trial</font>
2004-05-10 09:52 ET - News Release
Ms. Mimi Brennan reports
DIMETHAID TO MOVE AHEAD WITH PHASE I/II ANTIFUNGAL CLINICAL TRIAL
Health Canada's Therapeutics Product Directorate has approved a clinical trial protocol for an anti-fungal treatment under development by Dimethaid Research. The new drug -- Penecure -- targets onychomycosis, a common nail fungus disease, with a steadily rising incidence, particularly among diabetics, the elderly and people with immunosuppressive conditions.
Up to 13 per cent of North Americans now suffer from the disfiguring fungal disease, creating a treatment market estimated at approximately $1-billion in the United States, alone.
The new anti-fungal protocol was developed in consultation with regulatory officials at the U.S. Food and Drug Administration. Mimi Brennan, Dimethaid's director of regulatory affairs, said the seven-month, double-blinded, phase I/II trial will focus on dose-ranging and safety, although investigators will follow patients long enough to allow picking up initial efficacy trends.
"We believe this will give us the basic information we need, so we can proceed toward more advanced clinical trials and commercialization as quickly as possible," said Ms. Brennan.
Unlike current anti-fungal lacquers, Penecure has demonstrated an ability to deliver clinically therapeutic levels of active drug through nails, directly targeting the disease site. And because Dimethaid's site-specific technology minimizes exposure to active drug, the company expects its anti-fungal will significantly lower the risk of gastrointestinal problems, headaches, rashes and liver toxicity associated with current oral treatments.
Penecure's first clinical trial will enrol approximately 90 patients at four Ontario sites. Candidates, between the ages of 18 and 85, must have a clinical diagnosis of distal subungual onychomycosis in at least one greater toenail and be in otherwise good health.
Penecure has already passed a proof-of-concept study conducted at the University of California, as well as laboratory dose-ranging and accelerated stability studies. The treatment uses the same technology that underlies Pennsaid, the country's first prescription anti-arthritic lotion. Dimethaid successfully launched Pennsaid in Canada, last April, followed by product introductions in Italy and the United Kingdom. Additional launches are planned for Portugal and Greece before year-end.
WARNING: The company relies upon litigation protection for "forward-looking" statements. |
