Phase III trial of CUV1647 begins in Polymorphic Light Eruption
Monday 21st May 2007
Melbourne, Australia
Clinuvel Pharmaceuticals Limited (ASX:CUV, XETRA-DAX:UR9) is pleased to announce that the Phase III
trial of CUV1647 in Polymorphic Light Eruption (PLE/PMLE) has begun in Europe. The first group of patients
has received either the active implant containing photo-protective CUV1647 or a placebo implant.
This Phase III multicentre, randomised, double blind, placebo controlled study follows the Phase II results
from August 2006 in which CUV1647 significantly reduced the need for rescue medication, in the form of
steroids or anti-inflammatory drugs, in PLE patients. The Phase III trial will further determine whether
CUV1647 can prevent or reduce the severity of symptoms in patients with PLE/PMLE and also reduce the
use of rescue medication.
PLE/PMLE is a common sun induced skin disorder, known as sun poisoning. It consists of an intense and
persistent itchy rash with red blisters, bumps and patches on sun exposed skin. The current therapy
consists of sun avoidance and/or the use of steroids and/or phototherapy. PLE/PMLE can have a significant
social impact on sufferers because of their inability to go into bright sunlight in spring and summer.
Research has demonstrated that general practitioners are often unfamiliar with this disease. This fact,
combined with the lack of available and efficacious treatments other than steroids, results in only a fraction of
patients suffering from PLE/PMLE receiving effective treatment for their condition. Depending on the
outcome of the trial, Clinuvel aims to provide sufferers with a preventative treatment for PLE/PMLE.
The first site to start the Phase III trial is Hope Hospital, Manchester, UK. The remaining trial sites across
Europe are due to start administration of the implant soon. The trial will run across the 2007 and 2008
northern hemisphere spring and summer seasons and is scheduled to be completed in 2009. It is anticipated
that up to 150 patients will participate. Preliminary data will be available in 12 months (Q2, 2008) with the
final results in 2009.
Following the successful completion of the trial, Clinuvel will seek regulatory approval for CUV1647 to gain
market approval.
Clinuvel’s Chairman, Dr Roger Aston said:
“Starting the company’s first Phase III clinical trial is a major milestone for Clinuvel. These achievements will
bring us closer to the final goal of commercialising CUV1647.”
About Clinuvel Pharmaceuticals Limited
Clinuvel Pharmaceuticals Limited (ASX:CUV, XETRA/DAX:UR9, ADR:CUVLY) is an Australian
biopharmaceutical company developing its photo-protective drug CUV1647 as a preventative treatment for a
range of UV-related skin disorders as well as oncology related treatments. |
