Celtic Pharmaceutical Holdings L.P, the global private equity firm focused on the biotechnology and pharmaceutical industries, announced the enrollment of the first patient into the phase II trial of TDT-067, terbinafine in Transfersomes, for the treatment of onychomycosis.

This is an open-label study to explore the efficacy and safety of topically applied terbinafine delivered through the Transfersome targeted delivery technology. Celtic Pharma acquired an exclusive global licence to IDEA AG's Transfersome technology in February 2006.

Onychomycosis is a fungal infection of the fingernails and 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, especially among older individuals, (in the US it is estimated that Onychomycosis occurs in 7-10 per cent of adults). Present treatment options include both oral and topical drugs, with oral therapies giving better outcomes.

Innovative drug carriers called Transfersomes have been developed for the non-invasive 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 (applied directly to the skin) carrier-based dosage form of terbinafine for the treatment of onychomycosis of the toenail and fingernail.

"We are delighted to see this exciting drug/carrier combination enter phase II of its development, in which we endeavour to achieve proof of principle that this novel therapeutic approach will be efficacious. It is well established that current topical products for onychomycosis do not work well, as it is difficult to penetrate the nail to the site of the infection in the nail bed. However, many patients still choose topical treatments over systemic treatments due to the side effects associated with these systemic medications. We believe the epicutaneous application of terbinafine will benefit patients through improved delivery of terbinafine to the site of infection and consequently, TDT-067 represents a significant opportunity," said, Dr. Bob Milsted, Head, European Drug Development of Celtic Pharma.

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.