Celtic Pharma Announces Initiation of Phase III Trial of TDT 067 for the Treatment of Onychomycosis

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.  Whilst oral therapies can be successful in treating the disease, they carry the risk of side-effects, notably hepatotoxicity.  This results in physicians not being able to treat a large percentage of the people suffering from this disease.  There is a great opportunity for a safe and effective topical treatment and I believe that TDT 067 could be just that."

John Mayo and Stephen Evans Freke, Managing General Partners, Celtic Pharma said: "We are delighted to progress to Phase III clinical development of TDT 067, where we anticipate confirmation that this is a medically and commercially important advance in the treatment of this common disease.  Based on what we have seen in Phase II development, we believe that we have a product candidate that is comparable in efficacy to currently available oral therapy but without the potential for serious safety issues."

During Phase II development, TDT 067 achieved two orders of magnitude lower plasma terbinafine concentrations compared to oral terbinafine in a pharmacokinetic study conducted under conditions of maximal use.  In contrast, terbinafine levels measured in affected nails were three orders of magnitude higher than those reported for oral terbinafine.  This illustrates the targeted delivery of terbinafine.  In a Phase II efficacy and safety study, patients treated for only 12 weeks with a primary endpoint of mycological cure at 14 weeks and follow up to 48 weeks, a 90% mycological cure rate (as defined by negative culture and negative microscopic examination) was observed at 14 weeks.  At 48 weeks the mycological cure rate was still 38% despite no active treatment for the preceding 36 weeks. TDT 067 was well tolerated with negligible systemic exposure and no serious local side effects, confirming the maximal use study findings, suggesting that patients can be treated for longer durations which should enable improved efficacy.

About Onychomycosis (Fungal Nail Infection)

Onychomycosis is a fungal infection, generally of the toenails, that results in thickening, discoloration, splitting of the nails and lifting of the nail from the nail bed.  The disease has a high incidence within the general population -- estimated to be as high as 13% in the US -- especially among older individuals, with only a small percentage of patients being treated.  Present treatment options include both oral and topical drugs, with oral therapies giving better outcomes. However, these oral therapies have a black box warning and carry the risk of systemic side-effects, notably hepatotoxicity, that may be considered disproportionate to the disease being treated. This results in a large percentage of those affected by the condition not being given the most effective treatments available.

Notes for Editors

Innovative drug carriers called Transfersomes® have been developed for the noninvasive delivery of agents into or through the skin. Transfersome® preparations consist of complex lipid vesicles, which are able to cross the skin permeability barrier, the stratum corneum, driven by the transcutaneous water gradient. TDT 067 (terbinafine in Transfersomes®) is a novel, epicutaneously applied carrier-based dosage form of terbinafine for the treatment of onychomycosis of the toenail and fingernail.  Celtic Pharma acquired an exclusive global licence to IDEA AG's Transfersome® technology in February 2006. 'Transfersome' is a registered trademark owned by IDEA AG.

About Celtic Pharmaceutical Holdings L.P.

Celtic Pharmaceutical Holdings L.P. is a global private equity investment firm focused on the biotechnology and pharmaceutical industries.  Celtic Pharma was founded by Stephen Evans-Freke and John Mayo, CBE, and is based in Bermuda, with offices in New York and London. Celtic Pharma acquires and invests in late stage pharmaceutical programs and drives these programs through the final stages of regulatory approval. Celtic Pharma's aim is to bridge the gap between the established pharmaceutical companies' new product pipeline crisis and the biotech industry's capital drought.  For further information, please visit Celtic Pharma's website at www.celticpharma.com.

Forward-Looking Statements

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including: our dependence on third parties for the development, regulatory approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, risks associated with the costs of clinical development efforts, as well as other risks.  Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release. Celtic Pharma disclaims any intent or obligation to update these forward-looking statements.

SOURCE Celtic Pharmaceutical Holdings L.P.