Monday, August 28, 2006
Clinuvel (epitan / melanotan) completes small Phase II trial - "ample challenges ahead"
Clinuvel (was Epitan) has completed a small Phase II trial with patients suffering from Polymorphous Light Eruption (PLE). This is part of their strategy of ensuring targeting relevant dermatological diseases that benefit from increased sun protection via melanin.
"We have made a significant step forward in the development of CUV1647, but there are ample challenges ahead” said Clinuvel’s CEO, Dr Philippe Wolgen."
There is also an update on when Phase III trials are to start (they haven't yet), and complete (now slated for 2009...).
"Clinuvel is preparing to start Phase III clinical trials in Europe, Australia and the United States and remains on target to complete these by 2009. Following completion of the clinical development program, Clinuvel’s next steps will be to continue to work with regulators to facilitate the regulatory evaluation process."
Phase III trials in Australia have been cancelled and will now go ahead in Europe instead, they are planning to start them in 2007.
"CEO Philippe Wolgen
We’ve scheduled to begin PLE Phase III trials in Europe in early 2007. We’ve
already finalised the protocols and agreed trials with nine European sites and
are pressing for medical/ethical approval in EU countries. We are well on
target to start Phase III trials in early 2007. The PLE Phase III trials in
Australia are no longer planned. Focussing on one continent to do the Phase III
trial rather than spreading over two continents made more sense from an
organisational point of view." (source)
Worth noting that recently a rosacea sufferer posted about his positive experiments with the peptide Melanotan II (not Melanotan, which is the drug Clinuvel is developing). See the melanotan forums for more information on these drugs (note: I would assume that experimenting with unapproved peptides is potentially very dangerous -- please wait for the licensed version after 2009!).
See also the 28th August Q&A session with the CEO
"We have made a significant step forward in the development of CUV1647, but there are ample challenges ahead” said Clinuvel’s CEO, Dr Philippe Wolgen."
There is also an update on when Phase III trials are to start (they haven't yet), and complete (now slated for 2009...).
"Clinuvel is preparing to start Phase III clinical trials in Europe, Australia and the United States and remains on target to complete these by 2009. Following completion of the clinical development program, Clinuvel’s next steps will be to continue to work with regulators to facilitate the regulatory evaluation process."
Phase III trials in Australia have been cancelled and will now go ahead in Europe instead, they are planning to start them in 2007.
"CEO Philippe Wolgen
We’ve scheduled to begin PLE Phase III trials in Europe in early 2007. We’ve
already finalised the protocols and agreed trials with nine European sites and
are pressing for medical/ethical approval in EU countries. We are well on
target to start Phase III trials in early 2007. The PLE Phase III trials in
Australia are no longer planned. Focussing on one continent to do the Phase III
trial rather than spreading over two continents made more sense from an
organisational point of view." (source)
Worth noting that recently a rosacea sufferer posted about his positive experiments with the peptide Melanotan II (not Melanotan, which is the drug Clinuvel is developing). See the melanotan forums for more information on these drugs (note: I would assume that experimenting with unapproved peptides is potentially very dangerous -- please wait for the licensed version after 2009!).
See also the 28th August Q&A session with the CEO
