Hamilton, Bermuda--(Marketwire - October 15, 2007) -
Celtic Pharma Announces Initiation of Phase II Clinical Trial for
TDT-067, a Treatment for Onychomycosis
LONDON, NEW YORK and HAMILTON, BERMUDA, 15 October 2007 -- Celtic Pharmaceutical
Holdings L.P. ("Celtic Pharma"), the global private equity firm focused on the
biotechnology and pharmaceutical industries, announced today 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% 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.
Commenting on today's announcement, Dr. Bob Milsted, Head of European Drug
Development of Celtic Pharma said, "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."
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 programmes and drives these programmes 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.
Enquiries
Celtic Pharma
Kathy Armstrong
Tel: +1 212 616-4042
Kathy@celticpharma.com
John Mayo
Tel: +44 (0)20 7291-5400
Financial Dynamics
David Yates
Tel: +44 (0)20 7831-3113
David.yates@fd.com
Jonathan Birt
Tel: +1 (212) 850-5634
Jonathan.birt@fd.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.
This information is provided by RNS
The company news service from the London Stock Exchange