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Biotech / Medical : Clinuvel Pharmaceuticals Ltd -- Ignore unavailable to you. Want to Upgrade?

To: caly who wrote (22)	3/30/2010 8:42:26 AM
From: caly	Read Replies (1) \| Respond to of 52

Tuesday, March 30, 2010 Clinuvel Pharmaceuticals gets FDA approval for light intolerance drug trial Melbourne-based pharmaceutical company Clinuvel Pharmaceuticals (ASX: CUV) has been given the green light by US Food and Drug Administration to commence US patient trials involving its light intolerance drug. The disease, known as erythropoietic protoporphyria or EPP affects up to 3,000 Americans and is characterized by intolerable pain. Their skin blisters and burns when exposed to normal levels of light and sunlight. The disease is incurable and affects patients for life. Clinuvel will commence the Phase II study (CUV030) of its drug, afamelanotide, in up to 60 patients diagnosed with the rare light intolerance EPP condition. The six month study will be conducted in medical centres in Alabama, California, New York, North Carolina, Texas and Utah, is the first therapeutic trial of afamelanotide in the US. Most EPP patients spend most of their lives indoors and lead a secluded life. Sunscreens are of no use in this disease as they don’t block out visible light (in the blue spectrum), which is the cause of toxic reactions in EPP. Clinuvel has spent over A$70 million the past 10 years developing afamelanotide as the world’s first photoprotective drug. It works to activate a barrier of pigmentation (melanin) between light and a person’s skin. The implantable drug, the size of a rice grain, is able to stimulate and increase skin pigmentation in fair- skin patients who are less protected from UV damage. Afamelanotide has been administered to over 500 patients to date in clinical trials in Europe and Australia, with preliminary Phase III results showing good safety and first signs that EPP symptoms can be prevented. Clinuvel’s CEO, Dr Philippe Wolgen said today, “Clinuvel’s entry to the US to conduct a therapeutic trial is a major step event the company’s existence. In afamelanotide we are developing a unique drug to serve patients whose skin is most affected by ambient light." He said the company's goal is to develop a safe preventative therapeutic option for EPP patients, who are most severely affected by light and UV. The company is now in the position to develop afamelanotide for an orphan indication in the US.