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CLINUVEL's company releases, including archives.

Phase II trial of novel drug in erythropoietic protoporphyria (EPP) to commence immediately Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the US Food and Drug Administration (FDA) has agreed for Clinuvel to proceed under its current Investigational New Drug (IND) to conduct a Phase II clinical trial (CUV030) to evaluate afamelanotide as a first-in-class photoprotective drug in patients diagnosed with erythropoietic protoporphyria (EPP). This outcome is a breakthrough in Clinuvel’s global clinical program and will be the first therapeutic clinical trial of afamelanotide in the US. Afamelanotide was granted orphan drug designations (ODD) for EPP…
Clinuvel’s afamelanotide to be tested for absolute light intolerance in the United States A novel Australian drug to protect patients who are intolerant of light and sunlight will begin trials in the US next month. The US Food and Drug Administration (FDA) has given clearance to Melbourne’s Clinuvel Pharmaceuticals to commence a Phase II study (CUV030) of its drug, afamelanotide, in up to 60 patients diagnosed with the rare light intolerance erythropoietic protoporphyria (EPP). The six month study, to be conducted in medical centres in Alabama, California, New York, North Carolina, Texas and Utah, is the first therapeutic trial of…
Tuesday, 30 March 2010 10:00

Corporate Presentation - 30 March 2010

Corporate Presentation - 30 March 2010
Friday, 09 April 2010 09:00

Lapse of Unlisted Share Options

Lapse of Unlisted Share Options
Wednesday, 07 February 2007 11:00

Appendix 3X Ms Brenda Shanahan

Appendix 3X Ms Brenda Shanahan
Tuesday, 06 February 2007 11:00

New Non-Executive Director

Clinuvel Pharmaceuticals Limited (ASX:CUV) is pleased to announce that Ms Brenda Shanahan has been appointed to the Clinuvel Board of Directors as a non-executive Director. With over 20 years of experience in Australian and overseas economies and share markets, Ms Shanahan brings considerable financial and business expertise to Clinuvel. Ms Shanahan is well known in the business and financial community; her insights willadd significant value to the current Board and the company. Ms Shanahan is currently Chair of both St Vincent’s Health and St Vincent’s Medical Research Institute in Melbourne. She is a nonexecutive Director of JM Financial Group Ltd…
Wednesday, 31 January 2007 11:00

Open Briefing Clinuvel Phase III PLE Trials

Open Briefing Clinuvel Phase III PLE Trials
Clinuvel Pharmaceuticals Limited (ASX:CUV) is pleased to announce that ethics approval has been granted by the United Kingdom’s Central Office for Research Ethics Committees (COREC) to commence a Phase III clinical trial of Clinuvel’s photo-protective drug, CUV1647, in Polymorphous Light Eruption (PLE). This approval follows the company’s recent announcement regarding the approval of the Phase III PLE trial by the Medicines and Healthcare products Regulatory Agency (MHRA). The trial, to be conducted at Hope Hospital in Manchester, UK, is the first site to be granted the necessary regulatory and Medical Ethics Committees (MEC) approval. Patients are currently being recruited. Clinuvel’s…
Tuesday, 30 January 2007 11:00

Appendix 4C December 2006 Quarterly Report

Appendix 4C December 2006 Quarterly Report
Thursday, 25 January 2007 11:00

EGM Results

EGM Results

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