Clinuvel Pharmaceuticals (ASX: CUV) is an Australian biopharmaceutical company developing a photoprotective pharmaceutical under the generic name afamelanotide. The company's focus is to gain market approval for afamelanotide to manage the symptoms of severe sufferers of UV and light related skin disorders.
Clinuvel Pharmaceuticals’ U.S. trial shows positive results of accelerated repigmentation in people
Clinuvel Pharmaceuticals (ASX: CUV) has had early positive results from a U.S. clinical trial of its novel drug SCENESSE in patients with a loss of melanin (pigment) production that shows a possible acceleration in the repigmentation in patients.
Vitiligo is a disease in which there is a loss of melanin production resulting in white or off-white depigmented skin lesions on different parts of the body. Nonsegmental vitiligo, the most common subtype of the disease, affects more than 45 million patients worldwide.
Early observations in 21 patients with nonsegmental vitiligo (NSV) shows that monthly dosing of afamelanotide (SCENESSE), through a 16 milligram implant, in combination with narrowband ultraviolet B (NB-UVB) radiation therapy, has the capacity to achieve accelerated and deeper pigmentation of vitiliginous skin lesions.
Under the open label Phase II pilot trial, 50% of the patients enrolled are undergoing repigmentation treatment with NB-UVB therapy in combination with SCENESSE, while the remaining 50% are being treated with NB-UVB alone.
NB-UVB clinically administered three times per week over 18 months is considered the standard of care in NSV to stimulate repigmentation in depigmented skin and prevent the progression of lesions, but it is only partially effective as a standalone therapy.
A number of patients in this trial have required less NB-UVB dosing during the course of combination treatment. The majority of patients in this first cohort were African-Americans and Hispanic patients who have been diagnosed with NSV within the last five years.
The clinical objectives of the Phase II pilot trial are to determine whether SCENESSE reduces the total dose of radiation (NB-UVB) and the time required to reactivate skin pigment producing cells (melanocytes) in vitiliginous lesions.
Clinuvel announced the early clinical observations from the US open label Phase II pilot trial of Scenesse at the European Academy of Dermatology and Venereology meeting in Lisbon overnight.
The trial is ongoing across three centres in the U.S. – California, Michigan and New York – and is expected to be complete in early 2012.
A parallel study is under way in Europe across three centres in France, Italy and Switzerland. The two studies, the first in Clinuvel’s International SCENESSE Pilot Repigmentation Evaluation program, will recruit between 80 and 120 patients in total. Interim results from both studies are expected to be announced in the middle of 2012.
