Clinuvel receives approval to begin Phase III trials
Wednesday 24th January 2007
Melbourne, Australia
Clinuvel Pharmaceuticals Limited (ASX:CUV) is pleased to announce that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval, with immediate effect, to commence Phase III clinical trials of Clinuvel’s photo-protective drug, CUV1647, in Polymorphous Light Eruption (PLE).
PLE (or PMLE) is a condition also known as moderate to severe sun-poisoning in patients following exposure to UV-radiation. The disease is characterised by a severe skin rash marked by red blisters, vesicles and patches presented on areas of sun exposed skin. The reported incidence of PLE varies between 10-20%. The current therapy available to patients essentially consists of sun avoidance and/or the use of steroids and/or phototherapy. PLE usually has a significant impact on the quality of life of sufferers as they are unable to go into sunlight during spring and summer.
The primary objective of the multi-centre, double blind, placebo controlled trials is to confirm whether CUV1647 prevents or reduces the severity of PLE symptoms. Up to 200 patients are planned to participate in the trials, scheduled to run across the 2007 and 2008 spring and summer seasons. Preliminary data on the first season will be available in late 2007, early 2008.
Applications to begin Phase III trials across Europe have also been submitted to the relevant Medical Ethics Committees (MEC). Pending the MEC’s approval, Clinuvel plans to initiate the multi-centre trials in April 2007 (European spring).
The results of the Phase III trials will also assess the safety and efficacy profile of CUV1647 in treating patients with PLE. Following the successful completion of the trials, Clinuvel will seek regulatory approval for CUV1647 to gain market approval.
Philippe Wolgen, Clinuvel’s CEO said:
“The approval of Phase III clinical trials by a leading regulatory agency in Europe, the MHRA, is a major milestone in Clinuvel’s development of CUV1647. We are currently developing CUV1647 in four UV-related disorders, with PLE being the first indication to advance into Phase III.
Every effort has gone into optimising the clinical protocols and engaging with photo-dermatologists and experts worldwide. The relatively novel field of photobiology has virtually no available drugs to treat these patients.
Monitoring the safety and efficacy of the drug will continue to be my primary focus over the next 24 months”, he said.
Regulatory approval to begin Phase III trials follows a number of significant strategic achievements in 2006 including:
• The start of Phase II trials in Erythropoietic Protoporphyria (EPP) in Europe
• Successfully met endpoints in the Phase II trial on PLE (Melbourne) and Photo-protective efficacy trial (Sydney)
• Strengthened the intellectual property surrounding CUV1647
• Established a US office in San Francisco
• Raised $41.2 million in capital raisings
About Clinuvel Pharmaceuticals Limited
Clinuvel Pharmaceuticals Limited (ASX:CUV) is an Australian biopharmaceutical company developing its leading drug CUV1647 for the treatment of UV-related skin disorders. Clinuvel’s pioneering work aims to assist in preventing the global problem of UV related skin disorders, by developing CUV1647 in areas of unmet medical need.
Phase I and II human clinical trials using CUV1647 have demonstrated that it is well tolerated and no significant safety concerns have been identified.
Clinuvel is presently preparing to start further Phase II and begin Phase III clinical trials, with a view to complete them in 2009. Over the next few years and following completion of the clinical development program, Clinuvel will work closely with global regulators to facilitate market approval of CUV1647. |
