Clinuvel’s Drug Begins Global Phase II Skin Cancer Trials

Australia’s photo-protective drug company Clinuvel Pharmaceuticals has commissioned an immediate start to Phase II trials to test its drug CUV1647 as a preventative for sun damage and actinic keratosis (AK), which forms a precursor to skin cancer (SCC/BCC).

This announcement heralds the start of the Phase II trial in a precursor to skin cancer indication for the drug, aimed at providing prophylactic treatment for a large population of fair-skinned patients.

The trial will evaluate the drug’s ability to reduce the incidence of AK and irreversible skin damage in immune compromised organ transplant patients.

Fair skinned patients who have received organ transplants are 65-100 times more likely to subsequently contract skin cancers because of the side effects of critical life-long administration of immune suppressive drugs.

Around 150 patients at The Royal Melbourne Hospital and centres in Brisbane, Adelaide, and Europe will participate in the trial. The trial is expected to take two years.

CUV1647 stimulates the natural production of melanin, the natural pigmentation of the skin. Pigmentation protects skin from ultraviolet (UV) damage.

CUV1647 is delivered through a subcutaneous implant every 2 months, providing controlled release of CUV1647. Patients requiring long-term protection against UV-induced and irreversible skin damage, may receive multiple implants or continuous dosing during the years following successful transplant surgery.

Over the past years, Clinuvel has validated the photo-protective effect induced by CUV1647 in extensive animal studies and clinical trials. More than 300 patients worldwide have been treated with CUV1647 to date, and the drug has been shown to have a good safety profile.

The drug is currently being tested in two Phase III clinical trials, for the seasonal sun poisoning skin disease PLE and the absolute sun intolerance disease EPP.

Clinuvel is advancing its clinical program to develop a drug that offers photo protection for a population who are at high risk from UV exposure and damage.

During the past 18 months, investors have supported the Company with $67 million in funding enabling the Clinuvel to develop CUV1647 to gain market approval in 2009.