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TOPICA Begins Phase 2 Clinical Trial of Potent Antifungal, Luliconazole, in Athlete's Foot
Date:4/22/2009

PALO ALTO, Calif., April 22 /PRNewswire/ -- TOPICA Pharmaceuticals today announced the enrollment of patients in a Phase 2 clinical trial evaluating luliconazole for the treatment of tinea pedis (athlete's foot). Luliconazole, the company's lead product candidate, is the one of the most potent and broad spectrum molecules in the imidiazole class of antifungal agents, giving it the potential to provide physicians and patients with a needed topical solution to a variety of skin and nail fungal infections.

"The initiation of this trial represents a significant milestone for TOPICA as we begin our U.S. clinical development program of this promising drug candidate, which already has been proven in millions of patients in Japan," said Greg Vontz, president and chief executive officer of TOPICA. "We expect to complete this trial by the end of this year, potentially enabling us to initiate our pivotal Phase 3 clinical trial in 2010."

Phase 3 data from clinical studies conducted in Japan demonstrated that luliconazole successfully treated tinea pedis in half the time of commonly prescribed products. Since the 2005 approval of luliconazole in Japan for the treatment of tinea infections, more than 4 million patients have been safely treated with luliconazole. TOPICA has an exclusive license to develop and market luliconazole in the Americas and Europe.

The Phase 2, multi-center, randomized, double blind, trial is evaluating the safety and optimal duration of 1 percent luliconazole cream administered once daily for 14 or 28 days in patients with tinea pedis. The primary efficacy endpoint is to achieve complete clearance of the infection at two weeks post treatment. Currently in the U.S. available prescription medications generally require treatment once or twice a day for up to four weeks to achieve this result. The company expects to enroll approximately 120 patients in the trial, which is being conducted at 5 clin
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SOURCE TOPICA Pharmaceuticals
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