Melbourne, Australia October 31st 2007
Photo-protective drug company Clinuvel Pharmaceuticals (ASX: CUV; XETRA-DAX: UR9; US ADR: CLVLY) 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.
Dr Philippe Wolgen, Managing Director of Clinuvel said:
“Skin damage resulting from UV exposure and subsequent risk of skin cancer will touch most of us either directly or indirectly during our lives. There is clearly a great need to develop better protection against UV and the sun, especially in the changing environment of recent years.
After 2 years of preparation, we’re excited to begin testing of a treatment that is expected to prove to be a successful preventive therapy for organ transplant patients, who suffer the highest risk from UV and sun damage. If we are able to prove that we can reduce actinic keratoses and hence the development of skin cancer in these patients, we will have truly broken new ground. All empirical and clinical evidence to date suggests that skin pigmentation protects these patients. To succeed in this development program, we will need to remain vigilant and continue to carefully monitor safety and efficacy profiles in the trials over the next 24 months.”
“Our drug could serve larger patient populations if we are able to prove that melanin protects fair skinned organ transplant patients against UV and sun damage. In the meantime, we focus on advancing the development of CUV1647 as a photo protective drug in Phase III trials for EPP and PLE. ”
Clinical endpoints of the skin cancer trials in organ transplant recipients:
Primary endpoint: to determine the effect of CUV1647 on the number of actinic keratoses (AKs) on the head, back of hand and forearms during a 24 month test period.
Secondary endpoint: to determine the effect of CUV1647 on the number of squamous cell carcinomas (SCCs) on the head, back of hand and forearms during a 24 month test period.
Blinding status: double blind study
Product development status: controlled release formulation
Treatment method : one CUV1647 implant of 16 mg every 2 months for 24 months
Description of control group: one placebo implant of 16 mg every 2 months for 24 months
Trial standard: Phase II to ICH GCP standard
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 in cancer related treatments.
The five indications are:
Indication Description Clinical Trial Status
Polymorphic Light Eruption (PLE / PMLE) Sun poisoning Phase III trials began May 2007
Erythropoietic Protoporphyria (EPP) Absolute sun intolerance Phase III trials began June 2007
Squamous Cell Carcinoma (SCC) and Actinic Keratosis (AK) in organ transplant patients Non-melanoma skin cancers / precursor to skin cancers Phase II trials planned to begin 2007
Solar Urticaria (SU) Acute anaphylactic reaction to sun Phase II trials planned to begin 2007
Phototoxicity associated with Photodynamic Therapy (PDT) Photo-sensitivity associated with cancer treatment Phase II trials planned to begin 2007
Phase I and II human clinical trials using CUV1647 have demonstrated that the drug is well tolerated and no significant safety concerns have been identified to date.
Following successful conclusion of the development program, Clinuvel will work closely with global regulators to facilitate marketing approval of CUV1647.
For more information contact:
Colin Mackie Head of Corporate Development Clinuvel Pharmaceuticals Limited Tel: +61 3 9660 4900
investorrelations@clinuvel.com
Clinuvel is an Australian biopharmaceutical company focussed on developing its leading drug candidate, CUV1647, for a range of UV-related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward-looking statements), investors should note the following:
· actual results may and often will differ materially from these forward-looking statements;
· no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for CUV1647 can or will be achieved;
· no assurances can be given by Clinuvel that, even if its development programme for CUV1647 is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place
Level 11 / 330 Collins Street Melbourne, Victoria 3000 Australia T +61 3 9660 4900 clinuvel.com F +61 3 9660 4999
