白癜风新药SCENES SE即将在欧美地区进入实验

一个治疗世界上最令人痛苦的皮肤病之一——白癜风药物的试验即将在美国和欧洲开始。美国FDA已经同意新药SCENES SE（afamelanotide）进行预试验，以确定其是否可以帮助白癜风患者的皮肤重新着色。

白癜风是一种自身免疫性疾病，可导致片状皮肤颜色减退，且“病损”可扩散至全身。

SCENESSE是一种可模仿人体激活皮肤黑色素自然能力的注射用药物。该试验将对最常见的类型的白癜风即非节段性白癜风进行开展。

这种药物将与窄波段紫外线B光疗 (NB-UVB)联合进行试验，窄波段紫外线B光疗是一种经验证有效的治疗方法，但是需要持续接受治疗18个月，且每周2次或3次才能使皮肤恢复正常颜色。该试验的目的是确定SCENESSE是否可减少NB-UVB激活白斑病变区的皮肤色素细胞所需的剂量和时间。

该项研究的主要研究者、南加州色素沉着和白癜风研究所主任Pearl E Grimes医学博士对这种潜在新型白癜风治疗方法抱有乐观态度。

Grimes说到，白癜风是一种复杂的疾病，且治疗反应不一。这种潜在新型治疗方法联合现有的治疗很有前途，我们期待第一个临床结果的发布。

这项研究的赞助商生物制药公司Clinuvel正在全球6个专业白癜风中心对120例患者进行临床试验，美国（加利福尼亚州，密歇根州和纽约）和欧洲各3个。已在意大利获准进行试验，法国和瑞士正在等待审批。

Clinuvel 公司首席执行官PHilippe Wolgen博士说道，该公司收到了INSPIRE（国际SCENESSE复色评估）的试验众多人的询问。

在为期10年以上超过550例呼患者的临床试验中，已经证明SCENESSE的安全性与阳光和光保护药物一样。2012年在欧洲将可得到治疗罕见的光不耐受性红细胞生成性原卟啉病的药物，目前该药的试验正在进行。

Clinuvel to begin trial of Scenesse in US and Europe
Pilot trials of Clinuvel’s skin repigmentation treatment, Scenesse (afamelanotide), will begin in the US and Europe to treat vitiligo.
 
Clinuvel will initiate pilot trials of its drug Scenesse (afamelanotide) in the US and in Europe for patients with vitiligo.

Vitiligo is a disease which causes patchy loss of skin colour in ‘lesions’ which spread over the body. Onset of the disease can be sudden and lesions can spread quickly.

Read more about Clinuvel.

Scenesse is an injectable that mimics the body’s natural ability to activate the skin pigment melanin, and will be trialled in nonsegmental vitiligo, the most common form of the disease, which affects over 45 million individuals globally.

The drug will be tested in combination with narrow-band ultraviolet B (NB-UVB) light therapy, a recognised treatment but one which takes up to 18 months of twice- or thrice-weekly clinical visits to return pigment to the skin.

The goal of the trial is to determine whether Scenesse will reduce the dose of radiation (NB-UVB) and the time required to reactivate skin pigment producing cells in vitiliginous lesions.

Clinuvel is conducting the trial of up to 120 patients at six expert global vitiligo centres, three each in the US (California, Michigan and New York) and Europe. Approval for the trial has been granted in Italy with applications pending in France and Switzerland.