Navigation Links
Celtic Pharma Announces Presentation of Preclinical Data at the 69th Annual Meeting of the AAD in New Orleans

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.

Michael Earl, co-CEO of Celtic Pharma Development Services, said: "The in-vitro data presented at the AAD demonstrate that TDT 067 potentiates the anti-fungal effects of terbinafine and the entry 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 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

SOURCE Celtic Pharmaceutical Holdings L.P.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Neurobiological Technologies Partner, Celtic Pharma, Provides Update on XERECEPT(R) Clinical Program and Planned Sale in 2009
2. Celtic Pharma Holdings Announces Investment in Novacta Biosystems Limited
3. Keryx Biopharmaceuticals, Inc. to Hold Conference Call on Second Quarter 2008 Financial Results on Monday, August 11, at 8:30 A.M. EDT
4. SCOLR Pharma, Inc. Reports Second Quarter 2008 Financial Results
5. Par Pharmaceutical Reports Second Quarter 2008 Results
6. ISTA Pharmaceuticals Reports Second Quarter 2008 Financial Results
7. SGX Pharmaceuticals Announces Financial Results for the Three and Six Months Ended June 30, 2008
8. Best Practice Database Supports Bio-Pharma Product Launch
9. ADVENTRX Pharmaceuticals to Report Second Quarter 2008 Results
10. Pharmasset to Present at the Canaccord Adams Global Growth Conference on Tuesday, August 12th
11. Huifeng Bio-Pharmaceutical (HFGB) Announces USD $1.1 Million Supply Agreement with DNP International Co. Inc.
Post Your Comments:
(Date:6/23/2016)... TORONTO , June 23, 2016 /PRNewswire/ - ... Ontario biotechnology company, Propellon ... the development and commercialization of a portfolio of ... cancers. Epigenetic targets such as WDR5 represent an ... contribute significantly in precision medicine for cancer patients. ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... (Yeast and Mold) microbial test has received AOAC Research Institute approval 061601. , ... tests introduced last year,” stated Bob Salter, Vice President of Regulatory and Industrial ...
(Date:6/23/2016)... 23, 2016   EpiBiome , a precision microbiome ... in debt financing from Silicon Valley Bank (SVB). The ... to advance its drug development efforts, as well as ... "SVB has been an incredible strategic partner to ... traditional bank would provide," said Dr. Aeron Tynes ...
(Date:6/23/2016)... ... June 23, 2016 , ... In a new case report published today in ... patient who developed lymphedema after being treated for breast cancer benefitted from an injection ... for dealing with this debilitating, frequent side effect of cancer treatment. , ...
Breaking Biology Technology:
(Date:6/22/2016)... , June 22, 2016 On Monday, the ... to industry to share solutions for the Biometric Exit ... Customs and Border Protection (CBP), explains that CBP intends ... departing the United States , in ... to defeat imposters. Logo - ...
(Date:6/9/2016)... leader in attendance control systems is proud to announce the introduction of fingerprint attendance ... the right employees are actually signing in, and to even control the opening of ... ... ... Photo - ...
(Date:6/2/2016)... 2016   The Weather Company , an IBM Business ... industry-first capability in which consumers will be able to interact ... questions via voice or text and receive relevant information about ... Marketers have long sought an advertising solution that can ... personal, relevant and valuable; and can scale across millions of ...
Breaking Biology News(10 mins):