CLINUVEL has trialed or is currently trialing SCENESSE® (afamelanotide 16mg) as a photoprotective drug in a range of skin conditions which are caused or onset by exposure of skin ultraviolet and visible light. These are broadly grouped in two categories according to the length of light exposure required to elicit a symptomatic response: acute and chronic. The Company is focused on getting marketing authorisation for SCENESSE® for the orphan indication erythropoietic protoporphyria.
Chronic conditions: skin cancer
CLINUVEL is has conducted one clinical trial of SCENESSE® in a chronic light related skin disorder to determine the drug’s ability to prevent pre-cancerous and cancerous skin lesions in organ transplant recipient (OTR) patients. This two year study (CUV011) was conducted at sites across Europe and Australia. Read more…
Acute conditions: polymorphous light eruption, solar urticaria, photodynamic therapy
Trials of SCENESSE® in acute conditions have focused on two light related skin disorders (photodermatoses) and as an adjunct therapy to a common light therapy. Our lead program in acute skin conditions is for a form of porphyria called erythropoietic protoporphyria; you can read more about this program here.
Polymorphous light eruption (PLE) is the most common recurrent photodermatosis causing sensitivity and, after sunburn (solar erythema), is the most common sun-related problem seen by physicians. PLE is a distressing seasonal skin condition with episodes typically beginning in spring and resolving by late-summer or autumn, and symptoms include non-scarring, burning red papules, vesicles or plaques which appear on sun-exposed skin 30 minutes to several hours following exposure to sunlight. Data from a Phase III trial of SCENESSE® in PLE is currently being analysed.
Solar urticaria (SU) is a photodermatosis, with diverse clinical presentations and causes. SU is a rare subset of physical urticaria, where symptoms are induced by direct exposure of the skin to sunlight. As little as 5 minutes of sun exposure can cause flares and whealing on exposed skin sites, accompanied by severe itching. These symptoms can vary in manifestation, and anaphylaxis is a clinical risk. In 2009 CLINUVEL completed a Phase II study of SCENESSE® in 5 patients diagnosed with SU. Read the company’s Phase II solar urticaria results announcement.
Systemic photodynamic therapy is a treatment for cancers and premalignancies. In PDT, a photosensitising drug (PhotofrinTM) is administered intravenously to enhance and accelerate tumour treatment by LASER illumination. The photosensitiser in the tumour absorbs the light and produces an active form of oxygen that destroys nearby cancer cells.
Photosensitising agents such as porfimer sodium (PhotofrinTM) make skin and eyes ultra sensitive to light for up to 90 days following treatment. Patients suffer intense pain and second degree burns associated with this phototoxicity and are forced to avoid sunlight/artificial light for up to 90 days following treatment.
In 2009 CLINUVEL completed a Phase II study of SCENESSE® in patients undergoing PDT. Read the company’s Phase II PDT results announcement.