This blog is dedicated to all the Porphyria patients worldwide.
The American Porphyria Foundation will provide updates and information here, as well as on the main site - http://porphyriafoundation.com .
Sunday, April 28, 2013
SCENESSE~ What is it and how does it help Porphyria Patients
SCENESSE® (INN: afamelanotide) is Clinuvel's proprietary first-in-class photoprotective drug. Clinuvel has submitted a marketing authorisation application (MAA) for SCENESSE® to the European Medicines Agency for the orphan diseaseerythropoietic protoporphyria (EPP). Further studies of SCENESSE® are underway as a repigmentary agent in vitiligo and as a photoprotective for organ transplant recipient (OTR) patients.
SCENESSE® (pronounced "sen-esse") acts by increasing the levels of melanin in the skin; and shields against UV radiation (UVR) and sunlight. SCENESSE® is delivered via a subcutaneous dissolving implant approximately the size of a grain of rice. Increased pigmentation of the skin appears after two days and lasts up to two months.
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.
The skin's response to damage from UV radiation - Human tanning response
SCENESSE® is a chemical analogue of α-MSH and 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). SCENESSE® increases melanin content of the skin without exposure of the skin to the damaging effects of UVR.
Clinuvel is currently trialing SCENESSE® in a range of light and UV related skin disorders (photodermatoses) and as a repigmentation therapy in vitiligo. It is proposed that SCENESSE® will provide prophylactic treatment to patients suffering from photodermatoses by stimulating melanin to act as a photoprotective filtering the impact of UV to the skin. In vitiligo the drug is being evaluated in combination with narrowband ultraviolet B phototherapy (NB-UVB).
Over 700 patients have been treated with SCENESSE® in more than 20 clinical trials over several indications. Results to date suggest that the drug is well tolerated. In EPP trials, SCENESSE® has been shown to reduce the incidence and severity of phototoxic reactions.
Biomimicry of the human tanning response
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 SCENESSE® as a prescriptive drug. Clinuvel has been developing and testing SCENESSE® since 2000. Our development is focused on the SAFE and controlled administration of the drug substance.
WE STILL NEED YOUR PERSONAL LETTERS ON HOW THESE DRUG HAS HELPED YOU! TIME IS RUNNING OUT. CONTACT THE APF 866-APF-3635 FOR MORE DETAILS. WE NEED THIS DRUG APPROVED.