2009 Announcements

Trial in polymorphic light eruption (PLE) to support the final registration dossier of afamelanotide Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has obtained preliminary results in its multicenter randomised double-blind placebo controlled PLE study (CUV015) evaluating the safety and efficacy of afamelanotide 20 mg implants. PLE is a recurrent seasonal UV-related skin disorder seen mostly in fair-skinned patients (10-20% incidence) in the northern hemisphere. Preliminary evaluation of 36 patients with recurrent PLE revealed a trend toward reduction of characteristic dermal symptoms. Analysis of the physician’s Global Severity Index during the 120 days and 150…

US Office for Orphan Products Development (OOPD) issues designation for the use of afamelanotide in the management of sun-induced solar urticaria. Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its photoprotective drug afamelanotide has been granted an orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for the management of solar urticaria (SU). This is the second ODD granted to afamelanotide by the FDA since its awarded afamelanotide its ODD status for the treatment of erythropoietic porphyrias, a genetic haematological disorder. The FDA’s orphan drug designation is reserved for new drugs or therapies…

Afamelanotide as an adjunct therapy effective in pilot study of gastro-intestinal cancer treatment Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it had obtained positive results from an experimental trial evaluating the photoprotective effect of afamelanotide in 16 patients. The objective of this pilot Phase II trial was to determine the effect of a single 16mg dose of afamelanotide on the quality of life and phototoxicity in patients undergoing systemic photodynamic therapy (PDT), a treatment for certain gastro-intestinal cancers, in four clinics in France. In total 16 Caucasian patients were included, nine patients were administered afamelanotide…

Pilot study evaluating afamelanotide as adjunct therapy in systemic photodynamic therapy (PDT) Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it had obtained positive results from an experimental randomised placebo-controlled Phase II trial (CUV025) evaluating the photoprotective effect of afamelanotide in 16 patients. Objectives and results The objective of this exploratory trial was to determine the effect of a single 16mg dose of afamelanotide on the quality of life and phototoxicity in patients undergoing PDT. The trial was conducted by 4 French academic departments of gastro-enterology. Patients were followed up during 90 days. In total 16…

The European Medicines Agency grants Clinuvel SME status

Appendix 3Y

Results of Meeting

Clinuvel AGM 2009 Chair and CEO Presentation

Open Briefing. Clinuvel. CEO on MAA application to EMEA