Who is Clinuvel Pharmaceuticals?
Clinuvel Pharmaceuticals, Limited is a Melbourne based biopharmaceutical company focused on developing its leading drug candidate afamelanotide.
Currently in Phase II and Phase III clinical trials, afamelanotide is being developed as a preventative photoprotective agent for five clinical applications:
1. Erythropoietic Protoporphyria (EPP)
2. Solar Urticaria (SU)
3. Photodynamic Therapy (PDT)
4. Actinic Keratosis (AK) and Squamous Cell Carcinoma(SCC)
5. Polymorphous Light Eruption (PLE)
What exactly is "Afamelanotide"?
Afamelanotide (formerly CUV1647) acts by increasing the levels of melanin in the skin; and shields against UV radiation (UVR) and sunlight. Afamelanotide is delivered via a subcutaneous dissolving implant approximately the size of a grain of rice. Increased pigmentation of the skin appears after 2 days and lasts up to 2 months. It is proposed that afamelanotide will assist those patients who are most severely affected by UV and light, with the aim of improving their quality of life.
Alpha-Melanocyte Stimulating Hormone (α-MSH) is a naturally occurring peptide hormone which is released by skin cells in response to the stimulation by ultraviolet radiation (UVR). α-MSH has a very short half life (seconds) in the blood stream, sufficient to reach and stimulate other skin cells (melanocytes) which in turn produce and release melanin, a dark brown pigment. Melanin is known for its photoprotective effect.
Afamelanotide is a chemical analogue of α-MSH. Afamelanotide is a linear peptide with 13 amino acids. Two amino acids present in α-MSH have been changed and amplified to produce afamelanotide. This small change creates a more stable molecule with increased potent biologic effects and a longer half life (minutes). Afamelanotide increases melanin content of the skin without exposure of the skin to the damaging effects of UVR.
Clinuvel's mission is to develop afamelanotide for the most severely affected groups of patients susceptible to phototoxicity and photosensitivity of the skin caused by UV, sun and light. Patients diagnosed with porphyria1, polymorphous light eruption, solar urticaria, skin cancers and skin lesions2, as well as patients undergoing photodynamic therapy treatment3 provoked by UV and light are clinically eligible to receive afamelanotide every two months.
Clinuvel Pharmaceuticals Ltd is an ethical pharmaceutical company focused on providing photoprotective care of the skin. Clinuvel is working closely with global regulatory agencies to develop afamelanotide as a prescriptive drug. The company intends to complete Phase III trials in late 2009. Clinuvel has been developing and testing afamelanotide since 2000. Its development is focused on the SAFE and controlled administration of the drug substance.
1 Clinuvel is currently focused on prophylactic treatment of Erythropoietic Porphyrias in clinical trials of afamelanotide.
2 Clinuvel is currently focused on preventing actinic keratosis and squamous cell carcinoma of the skin in organ transplant recipients in clinical trials of afamelanotide.
3 Clinuvel is currently focusing on systemic PDT treatments.
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