EPITAN - Clinuvel Pharmaceuticals

EPITANincreased melanin density in healthy adult subjects. The implant dose range used was5mg-40mg. Preliminary results have indicated that only one-tenth of the dose used inthe original daily liquid dosing regime may required to be released by the implant andthat pigmentation is achieved at a quicker rate. Compared to the original dailysubcutaneous liquid injection studies, there were significantly fewer adverse events.Current and future clinical trialsPrevention of sunburn injuryEpiTan has now received ethics committee approval to conduct a Phase II trial(EP008) to evaluate the photoprotective effect of a sustained release dose ofMELANOTAN. The aim of the study is to evaluate MELANOTAN sustainedrelease for the protection of sunburn injury, as a prophylactic drug for people withFitzpatrick types I and II, by establishing a protection rating for MELANOTAN similarto that used in sunscreens. The trial is scheduled to begin in April 2005 in Australia andrun for approximately six months. The results from this trial will be put to regulators forapproval to conduct a Phase III trial (EP009).A further trial (EP003) is planned to begin in June/July 2005 to evaluate the efficacy ofthe implant in individuals with normal and variant genotypes for the Melanocortin 1receptor. These polymorphisms can lead to a loss or reduction in melanin production. Ifpositive results are obtained this would provide supportive information for theprescribing of MELANOTAN for individuals of Fitzpatrick types I and II where a largeproportion of the individuals are likely to have a variant genotype. The trial is likely torun for 12-18 months and will therefore run alongside the planned Phase III trials.The final clinical trial in the development of MELANOTAN for the prevention ofsunburn injury is likely to be the Phase III multi-centre worldwide trial (EP009). Weexpect this trial to begin in 2006 and include approximately 1,600 individuals. Ifsuccessful we expect the product to be filed for approval with regulatory authorities inEurope, US and Australia in 2007, with marketing approval likely in 2008.Treatment of PMLEIn January 2005, EpiTan commenced a Phase II clinical trial (EP005) in Germany toevaluate the safety, tolerability and efficacy of the subcutaneous implant ofMELANOTAN in patients suffering from PMLE. The trial was expanded to Finland inMarch 2005 with the total number of patients in the trial expected to be 20. Dependenton the results of this trial, we expect EpiTan to begin a Phase III trial in PMLE in early2006 in Europe in approximately 200 patients.Topical formulationAlthough EpiTan is currently progressing the sustained release implant as its leadformulation, it is also evaluating further delivery formulations which could easeadministration and potentially expand the market for the product.The lead alternative formulation is a transdermal delivery system (TDS) containingMELANOTAN. TDS has been developed by Transdermal Technologies Inc.,Florida, US. In April 2005, clinical trial EP007 will commence to investigate the safetyand efficacy of this spray formulation and to establish the optimal dosing. The trial willbe conducted by the William Harvey Research Institute at Queen Mary, University ofLondon. If successful we would expect EpiTan to proceed with further trials for thisformulation.An additional transdermal lotion is also under development. In May 2003, EpiTaninitiated a collaboration with CollaGenex Pharmaceuticals (US) and Thomas Sköld(Sweden) to develop a lotion using Restoraderm ® technology for the topical delivery ofMELANOTAN. This could also provide an additional alternative formulation ofMELANOTAN which may further expand the potential market for the product.11