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CLINUVEL's company releases, including archives.

Thursday, 26 November 2009 11:00

Appendix 3Y

Appendix 3Y
Monday, 30 November 2009 11:00

The European Medicines Agency grants Clinuvel SME status

The European Medicines Agency grants Clinuvel SME status
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…
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…
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…
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…
Significant pain reduction is demonstrated in light-intolerant patients with erythropoietic protoporphyria (EPP) Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has obtained promising 4-months results in testing afamelanotide in a multicentre randomised double-blind placebo controlled Phase III study in EPP (CUV017). In 2008, afamelanotide was awarded orphan drug designation (ODD) in the treatment of EPP by the FDA and EMEA. EPP patients are known to be absolutely intolerant to visible and UV light. This genetic disorder leads to an accumulation of protoporphyrin IX in the skin and an increased risk of incapacitating phototoxic reactions manifesting…
Thursday, 14 January 2010 11:00

Lapse of Unlisted Share Options

Lapse of Unlisted Share Options
Thursday, 14 January 2010 11:00

Appendix 3B

Appendix 3B
Friday, 29 January 2010 11:00

Appendix 4C

Appendix 4C

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