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Trial progress

Clinical trials for new pharmaceutical compounds in humans are conducted in “Phases”:

  • Phase I studies test a compound in “healthy” subjects, who do not suffer from specific medical indications for which a compound may be effective;
  • Phase II studies are studies in subjects who suffer from a particular disorder for which the drug may be effective in treating or preventing that disorder. Phase II studies are generally conducted in a small number of patients as ‘proof of concept’; showing that a compound has potential to treat or prevent a disorder;
  • Phase III studies are larger studies in patients suffering from a particular disorder to determine the potential of a drug in a larger number of patients. These controlled studies generally run for much longer than Phase II studies and involve greater numbers of patients. Following a successful Phase III study, showing that a compound is safe and effective to treat a disorder, pharmaceutical developers will generally pursue marketing approval of their product in the jurisdictions of the study;
  • Phase IV studies are also known as ‘post marketing’ studies. These may be requested by regulators after a compound has received marketing approval to validate safety or efficacy data found in Phase III studies.

More information and discussion on clinical trials and pharmaceutical development can be found on the Clinuvel Blog.

Clinuvel has progressed its clinical trial program with afamelanotide to Phase III in Australia and Europe for two indications – Erythropoietic Protoporphyria (EPP) and Polymorphous Light Eruption (PLE).

Phase III trials in Solar Urticaria (SU) are due to commence in the northern hemisphere spring of 2010 in Europe.

The company has commenced Phase II trials in Actinic Keratosis/Squamous Cell Carcinoma in Australia and Europe. For more information on all of the idendified indications for afamelanotide, click here.

Clinuvel intends to begin trials in its clinical indications in the USA in 2010 and is awaiting regulatory approval to continue its program.