About CLINUVEL

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Absolute light intolerance: Erythropoietic protoporphyria (EPP)

10 Jan 2010
Erythropoietic protoporphyria (EPP) is a rare and severe UV/light related skin disorder. The Australian outdoor lifestyle has ingrained in us a distinct awareness and understanding of the dangers of sunlight and UV exposure. This unique insight makes knowledge of photodermatoses (UV/Light related skin disorders) all the more profound. Erythropoietic protoporphyria (EPP) is a rare genetic disease where patients have a deficiency of an enzyme called ferrochelatase. These patients aren’t able to convert protoporphyrin IX (PPIX) into heme and so they accumulate PPIX in their body. When exposed to light and UV, PPIX causes a phototoxic reaction, resulting in intolerable burning pain and causing EPP patients to avoid light/UV exposure. CLINUVEL, an Australian Company, understands the needs of Australians to enjoy the great outdoors and the needs of people globally suffering…

"Separate yourself from the pain"

06 Jan 2010
Adrian was diagnosed with the genetic disease Erythropoietic Protoporphyria (EPP) when he was 5. Exposure to light causes him excruciating pain. EPP is characterised by the accumulation of toxic compounds in the body of patients. Exposing an EPP patient’s skin to light, particularly blue light, causes excruciating pain: intense burning, stinging heat. Adrian describes EPP as similar to having badly sunburnt skin scrubbed with a wire brush. Swelling and blistering can also form after extended time exposure. Even artificial lights, such as those in supermarkets and laptop screens can cause acute pain. EPP is a lifelong disorder presenting in early childhood. The onset of the disease is traumatic for both children and parents. Sun avoidance is the mainstay of treatment for EPP: patients are often forced to remain indoors, severely…

Clinuvel, improving quality of life

02 Jan 2010
Afamelanotide holds promise as a preventative pharmaceutical treatment, improving quality of life for patients with advanced stage bile duct cancer, who are eligible to undergo Photodynamic Therapy (PDT). CLINUVEL is committed to caring for patients who do not receive medical attention for light and UV related diseases. We believe strongly in prevention and we are aware of the importance of quality of life. In 1993 the US NCI provided the seed funding to research a molecule for the prevention of skin cancer. CLINUVEL spent 9 years to commercially develop this molecule into a viable preventative product to treat severe light and UV related skin disorders. Through study of preventative applications we have uncovered afamelanotide's potential as a treatment for cancer patients undergoing PDT. In PDT, similar phototoxic reactions are observed…

"Where no one has gone before"

03 Oct 2009
CLINUVEL Non-Executive Director Jack Wood discusses commercialization. CLINUVEL is developing a breakthrough photoprotective drug, Scenesse (afamelanotide), to be administered every 60 days. Scenesse is selective in its pharmacologic action by activating skin's own pigment, melanin. It is due to melanin that a physical barrier between skin and light of all wavelengths -particularly UV- is provided. Medically this is known as photoprotection. The CLINUVEL team worldwide is testing Scenesse in 5 indications currently in Phase II and III clinical trials. Eligible for these trials are patients who suffer from UV and light related skin disorders, ranging from those who suffer from porphyrias to those affected by skin cancer.

"the golden age?"

09 Sep 2009
CLINUVEL Non-Executive Chair Brenda Shanahan and Non-Executive Director Roger Aston discuss the progress of CLINUVEL's clinical program with Scenesse (Afamelanotide) Administered by physicians as a controlled-release resorbable implant, Scenesse is a preventative drug activating melanin - pigmentation - in the skin. Melanin provides a biological barrier, protecting skin from UV and visible light. Medically, this is known as photoprotection. Scenesse is released over 10 days by the implant, while activating melanin for up to 60 days. The breakthrough controlled-release formulation maximizes the effect of the drug, while minimizing patient exposure to drug substance. CLINUVEL’s ongoing clinical program aims to demonstrate the safety and efficacy of Scenesse as a medicinal photoprotective drug.

Clinuvel's regulatory strategy

29 Aug 2009
CLINUVEL's CSO, Dr Hank Agersborg, on the final year of drug filing CLINUVEL's ASX announcement on the SU results can be found here. Read the CEO's Technical note on the Phase II results here. This audio file is available for download in mp3 format. Right click here and select "Save target as" to save this file to your computer.

The evolution of pharmaceutical development

16 Aug 2009
CSO, Dr Hank Agersborg, discusses drug development at CLINUVEL This audio file is available for download in mp3 format. Right click here and select "Save target as" to save this file to your computer.

Final year of filing MAA

13 Jul 2009
CLINUVEL's CSO, Dr Hank Agersborg, on the final year of drug filing CLINUVEL's ASX announcement on the SU results can be found here. Read the CEO's Technical note on the Phase II results here. This audio file is available for download in mp3 format. Right click hereand select "Save target as" to save this file to your computer.

"Clinical and regulatory goals"

19 May 2009
CLINUVEL's senior management in regulatory affairs and clinical research discuss the development of CLINUVEL's proprietary first-in-class drug, SCENESSE® (afamelanotide). Administered by physicians as a controlled-release resorbable implant, SCENESSE® is a preventative drug activating melanin - pigmentation - in the skin. Melanin provides a biological barrier, protecting skin from UV and visible light. Medically, this is known as photoprotection. SCENESSE® is released over 10 days by the implant, while activating melanin for up to 60 days. The breakthrough controlled-release formulation maximizes the effect of the drug, while minimizing patient exposure to drug substance. CLINUVEL’s ongoing clinical program aims to demonstrate the safety and efficacy of SCENESSE® as a medicinal photoprotective drug.

Light & UV In Australia

10 May 2009
Australians have a love for their outdoors and a great appreciation for sunshine. With our appreciation comes understanding, and with that understanding, a healthy respect of the sun. In Australia, sun safety is paramount and education starts early. Year round, Australians are exposed to high levels of UV; two in three Australians are expected to be diagnosed with skin cancer by the age of 80. Education in sun awareness is essential: even during a Melbourne winter, UV levels can be high, skin damage can occur on overcast days. Recognising the potentially harmful properties of both controlled artificial light and natural light, at Clinuvel we have built an Australian company to compliment Australia's awareness in light and UV: using this understanding in our research into medicinal photoprotection.
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