Celtic Pharma Announces Presentation of Preclinical Data at the 69th Annual Meeting of ...
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`Celtic Pharma Announces Presentation of
`Preclinical Data at the 69th Annual Meeting of the
`AAD in New Orleans
`-- Transfersome® Trans-Dermal Delivery System potentiates terbinafine's anti-fungal activity
`in TDT 067 --
`
`Feb 07, 2011, 08:00 ET from Celtic Pharmaceutical Holdings L.P. (http://www.prnewswire.com/news/celt-
`ic+pharmaceutical+holdings+l.p.)
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`LONDON, NEW YORK and HAMILTON, Bermuda, Feb. 7, 2011 /PRNewswire/ -- Celtic
`Pharmaceutical Holdings L.P. ("Celtic Pharma"), the global private equity firm focused on the
`biotechnology and pharmaceutical industries, announced today the presentation of key in-vitro
`data at the American Academy of Dermatology (AAD) 69th annual meeting in New Orleans (4-8
`February, 2011) for TDT 067, terbinafine in Transfersomes®, for the topical treatment of
`onychomycosis (also known as a fungal nail infection).
`
`The first of the two in-vitro studies presented by the lead investigator, Professor Mahmoud
`Ghannoum, Director of the Centre for Medical Mycology at Case Western Reserve University in
`Cleveland, Ohio, investigates the activity of TDT 067 against the common causative agents of
`onychomycosis as measured by minimum inhibitory and fungicidal concentrations. The data
`demonstrate that TDT 067 has potent inhibitory and fungicidal activity against dermatophyte
`strains, and that the fungicidal activity of TDT 067 is shown to be more potent than conventional
`terbinafine preparations.
`
`In a second in-vitro study, presented by Professor Ghannoum, the morphology and ultrastructure
`of dermatophyte hyphae were investigated following exposure to TDT 067 using scanning electron
`microscopy (SEM) and transmission electron microscopy (TEM). The data show that terbinafine
`formulated in Transfersomes® in Celtic Pharma's TDT 067 drug candidate potentiates the action of
`terbinafine by enabling it to penetrate more effectively to its site of action inside the fungus, where
`it disrupts the intracellular matrix leading to eventual death of hyphae.
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`http://www.prnewswire.com/news-releases/celtic-pharma-announces-presentation-of-precl...
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`5/24/2016
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`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2178 - 1/5
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`Celtic Pharma Announces Presentation of Preclinical Data at the 69th Annual Meeting of ...
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`-
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`Pharma Development Services, said: "The in-vitro data presented at
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`of the drug into dermatophyte hyphae, which we believe will provide a significant clinical benefit for
`the treatment of onychomycosis. We hope to see confirmation of this benefit through the on-going
`pivotal clinical trial."
`
`TDT 067 is currently in Phase III development. A 42 center global trial is currently in progress and
`has fully enrolled the planned 776 patients. The study is powered to provide registrational data on
`the efficacy, tolerability and safety of topically applied terbinafine delivered through the
`Transfersome® targeted delivery technology over 48 weeks. Transfersomes® are a trans-dermal
`drug delivery system that enables delivery of high concentrations of drug to deep tissue without
`significant systemic exposure to the drug, so TDT 067 is designed to obviate the hepatotoxicity
`issues associated with oral administration of terbafine.
`
`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 diagnosed 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
`risk 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 Transfersome®) is a novel, epicutaneously
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`technology in February 2006. 'Transfersome' is a registered trademark owned by IDEA AG.
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`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.celticphar-
`ma.com.
`
`SOURCE Celtic Pharmaceutical Holdings L.P.
`
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