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EpiTan Limited (ASX: EPT, ADR: EPTNY, XETRA: UR9), Melbourne, Australia has announced that approval has been obtained from the UK's regulatory agency - The Medicines and Healthcare products Regulatory Agency (MHRA) - to begin a human trial for a newly developed topical formulation for its melanin-inducing drug Melanotan.

The Phase I/II clinical trial is scheduled to begin in April 2005 following a one-month stability trial.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK equivalent to Australia's Therapeutic Goods Administration (TGA) and USA's Food and Drug Administration (FDA).

The trial is to be conducted at the William Harvey Research Institute based at St Bartholomew's & The Royal London School of Medicine and Dentistry in London. Up to 30 healthy volunteers will receive increasing doses of Melanotan in a transdermal delivery formulation.

The topical formulations will be applied as a 1 mL solution, sprayed onto the arm daily for ten days. This formulation is expected to enable the drug to be equally distributed throughout the body systemically. The clinical trial's objectives include investigating both the safety and efficacy of Melanotan in this new formulation, as well as establishing the optimal dose. The full details of the trial will be announced on completion of the stability study.

EpiTan filed a provisional patent with the United States Patent and Trademark Office in October 2004 to protect the commercial use of this topical Melanotan formulation.

The patented transdermal delivery technology, known as TDSR, was developed by Florida-based TransDermal Technologies, Inc (TTI). TDS is unique because the composition is specific for each drug. The results of EpiTan's preclinical studies have shown clearly that the TDS formulation can deliver systemically a large peptide through the skin of animals.

About EpiTan

EpiTan Limited is a Melbourne-based specialty pharmaceutical company with a focus on niche prescription dermatology products. Its leading drug candidate MelanotanR stimulates the body to make melanin, the dark pigment of a tan which is known to protect the body from skin damage as a result of exposure to ultra-violet (UV) radiation. UV radiation damage can cause sunburn which is a known prime cause of skin cancer. Simply, Melanotan induces a protective tan without the need to expose the skin to harmful levels of UV radiation. EpiTan recently acquired three products - LinotarR (eczema), ExorexR (psoriasis) and ZindaclinR (acne) - and is currently evaluating the acquisition or in-licensing of other dermatology-based products to add to its portfolio.

About Melanotan

Melanotan has completed a Phase II clinical trial in Australia which demonstrated the drug increases melanin content by up to 100% and reduces sunburn injury by up to 50% in fair-skinned volunteers. This represents a significant breakthrough for people most at risk of sunburn injury and potentially skin cancer. EpiTan is expanding its clinical studies of Melanotan in Europe and the USA. These trials will assess its potential both as a preventative to reduce the effects of UV damage and as a therapy for UV-associated skin disorders such as polymorphous light eruption (PMLE). Melanotan has a number of delivery formulations in development. The most advanced is a user-friendly and biodegradable sustained-release implant, administered by a single injection. The testing of a selection of transdermal formulations is also in progress.

An independent report commissioned by the company identified that there are three potentially lucrative markets for Melanotan. Firstly, the prophylactic market which includes those populations that do not tan well and seek additional protection from UV damage. Secondly, the therapeutic market consisting of patients with UV-associated skin diseases or disorders for which Melanotan may provide a clinical benefit and, finally, the cosmetic market comprising those people who want a tan, but not specifically for health reasons.

About William Harvey Research Institute

The William Harvey Research Institute was founded by the Nobel Laureate Sir John Vane, FRS in 1985. It was established at St. Bartholomew's Hospital with initial financial support from Glaxo. Sir David Jack, former head of Glaxo, was the first Chairman of the Trustees of the William Harvey Research Institute (1995-2000). Pharmaceutical companies from Europe, USA and Japan have funded major research programmes, and the Institute is now world-renowned as a centre of excellence for cardiovascular and inflammation research. In 1996, the Institute became part of Barts and the Royal London School of Medicine and Dentistry (Queen Mary University).

Today, the William Harvey Research Institute has more than 150 researchers and is one of the leading centres for pharmacological research in the United Kingdom. Several senior scientists within the Institute are among the 100-leading pharmacologists in the World and the Institute is ranked among the Top 20 Pharmacological Research institutions (based on citations) in the World (according to The Scientist, 2004).

About TransDermal Technologies, Inc.

TransDermal Technologies, Inc. (TTI), a private company based in Florida, USA, specializes in leveraging its patented rapid acting, drug-specific transdermal delivery technology to develop effective alternative delivery systems for valued drugs.

The company's platform technology, TDSR, is a patented physio-chemical and mathematical process for designing a system capable of temporarily neutralizing the skin's barrier function, enabling delivery to or through the skin, to local tissues or to the whole body, of a very wide range of compounds with pharmaceutical or cosmetic value.

The U.S. Patent & Trademark Office has granted TTI patents on its platform technology and there appear to be no similar technologies.

For more information, call 561/848-9100.
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Publication:Worldwide Biotech
Date:Mar 1, 2005

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