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Biotech / Medical : Clinuvel Pharmaceuticals Ltd

CLVLY 7.350

-2.3%

Oct 31 9:30 AM EST

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To: caly who wrote (8)	3/6/2005 8:34:24 PM
From: caly	Read Replies (1) of 52

Monday 7 March 2005 EpiTan receives ethics approval for Phase II “Endpoint” study in Sydney Melbourne, Australia EpiTan Limited (ASX: EPT, ADR: EPTNY, XETRA: UR9) today announced it had obtained ethics approval for a Phase II study to evaluate the photoprotective effect of a sustained release dose of Melanotan ® . (See Appendix 1). The trial is designed to validate a specific endpoint for Melanotan for fair-skinned Caucasians – the expected targeted patients for this therapy. The trial aims to establish a “protection” rating for Melanotan similar to that used in sunscreens i.e. Sun Protection Factor or “SPF”. Subject to regulatory acceptance, this endpoint will be used in Phase III studies. The Principal Investigator for the trial will be Professor Ross Barnetson, Head of Dermatology at the Royal Prince Alfred Hospital, Sydney. Professor Barnetson was the Principal Investigator for the company’s Phase II Sunburn trial in 2003 using daily liquid injections. The endpoint trial is scheduled to begin in April 2005 and is expected to take six months to complete. It is anticipated that it will be one of the final trials of Melanotan ahead of Phase III studies.

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