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Celtic Pharma Announces Initiation of Phase III Trial of TDT 067 for the Treatment of Onychomycosis
Date:4/30/2010

LONDON, NEW YORK and HAMILTON, Bermuda, April 30 /PRNewswire/ -- Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma"), the global private equity firm focused on the biotechnology and pharmaceutical industries, announced today the enrolment of the first patient into its Phase III trial of TDT 067, terbinafine in Transfersomes®, for the topical treatment of onychomycosis (also known as a fungal nail infection).  

This Phase III trial is a three-arm, double-blind study to be conducted in approximately 40 centers around the world.  It is powered to provide potentially registrational data on the efficacy, tolerability and safety of topically applied terbinafine delivered through the Transfersome® targeted delivery technology over 48 weeks. PPD Inc., a leading global contract research organization, has been appointed to conduct the study.

Dr. Phoebe Rich of Oregon Dermatology and Research Center, Oregon Health and Sciences University, the Principal Investigator for North America said, "This important trial uses exciting new technology to deliver antifungal drug deep into the site of infection in the nail.  This drug could potentially address the huge unmet need for topical therapy for onychomycosis."  

Dr. Bardur Sigurgeirsson, Department of Dermatology, University of Iceland, the Principal Investigator for Europe added, "I am delighted to be involved in the trial of this innovative new product, which I believe to be an important advance in this therapy area.  There is a huge demand for a safe and effective treatment for onychomycosis.  Whils
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SOURCE Celtic Pharmaceutical Holdings L.P.
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