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Epitan Completes Recruitment
and Dosing for Photoprotection Trial in Sydney
Thursday 29 September 2005 -
Melbourne, Australia: Epitan
Limited announced today that it has completed recruitment for its Phase II
photoprotection clinical trial (EP008). The trial is designed to measure the
photoprotective effects of its melanin-producing drug EPT1647 on the skin
following a single subcutaneous administration of a sustained release implant.
The 45 subjects have now received study medication. The trial is expected to be completed in early 2006 with the final report available in June 2006. The Principal Investigator is Professor Ross Barnetson, Head of Dermatology at the Royal Prince Alfred Hospital, Sydney. Over a 12 week period, the study is designed to measure both increases in melanin density at various anatomical sites and the sensitivity of the skin as measured by the minimal erythema index (skin reddening following exposure to UV radiation). Iain Kirkwood, CEO and Managing Director of Epitan, said: "Erythema is one of the main exaggerated symptoms of sufferers of Polymorphous Light Eruption (PMLE), so this trial will contribute important safety data towards our marketing application as well as further test our sustained release implant. "Another important aspect of this trial is to continue to determine the relationship between the types of MC1-receptor of each subject versus their response to EPT1647. It is known that people with certain receptor variations are potentially more susceptible to UV-induced skin damage." About Epitan Epitan Limited (ASX: EPT, ADR: EPTNY, XETRA: UR9) is a Melbourne-based pharmaceutical company with a focus on prescription dermatology products. Epitan has two primary activities: (1) to complete the remaining clinical development of its leading drug candidate EPT1647, for which Epitan holds exclusive worldwide rights in the field of use for melanogenesis and (2) marketing and selling prescription dermatology products in Australia and New Zealand. As at September 2005, Epitan has five drugs in its portfolio of dermatology products. Epitan continues to evaluate the in-licensing of additional similar products although its main focus is to complete the development and commercialisation of EPT1647 for the world markets. About EPT1647 EPT1647 is the new non-proprietary name for Epitan's MELANOTAN. MELANOTAN is Epitan's brand name for [Nle4, D-Phe7]-α-MSH. From June 2005, Epitan is using EPT1647 rather than its brand name to avoid any confusion between MELANOTAN (or MT-I) and other chemicals such as Melanotan-II (or MT-II) and melatonin. EPT1647 stimulates the body to make eumelanin, the dark pigment of the skin which is known to have protective effects on the skin from exposure to both UV-A and UV-B radiation. Simply, EPT1647 is a photoprotective agent that acts by increasing the levels of eumelanin in the skin without the need to expose the skin to UV radiation. Therefore, it has the potential to be used as a photoprotective agent for those persons seeking additional protection from UV damage, because their levels of eumelanin do not normally increase when they are exposed to UV radiation or persons who suffer from the clinical symptoms of UV associated skin diseases and disorders, such as Polymorphous Light Eruption (PMLE). For more information contact: Davina Gunn, Investor Relations & Marketing, Epitan Limited, Tel: +61 3 9660 4900 investorrelations@epitan.com.au Richard Allen, Oxygen Financial Public Relations, Tel: +61 3 9915 6341 Richard Allen Oxygen Financial Public Relations Level 13, 90 Collins Street Melbourne, 3000, Victoria, Australia Ph: +61 (0)3 9915 6341 email: richard@oxygenpr.com.au |
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