SAN DIEGO--(BUSINESS WIRE)--Nielsen BioSciences, Inc. (“Nielsen”), a privately-held, San Diego-based biopharmaceutical company, today announced the first patient enrolled in CFW-3A – a Phase 3, randomized, double-blind, placebo-controlled study of the safety and efficacy of CANDIN® for the treatment of Verruca vulgaris (common warts) in adolescents and adults.

圣地亚哥--（商业新闻短讯）--尼尔森生物科学公司（Nielsen BioSciences，Inc.），一家总部位于圣地亚哥的私营生物制药公司，今天宣布了第一名参加CFW-3A的患者，这是一项关于CANDIN®治疗青少年和成人寻常疣（寻常疣）的安全性和有效性的3期随机双盲安慰剂对照研究。

The study is ongoing and will continue to enroll patients across sites in the U.S. and Japan, making this Nielsen’s first clinical study with global reach. Nielsen is partnering with Maruho Co. Ltd. (“Maruho”) in the clinical development program for CANDIN. Maruho is also planning to commercialize CANDIN in Japan..

这项研究正在进行中，并将继续在美国和日本的各个地点招募患者，这是尼尔森公司首次在全球范围内进行临床研究。尼尔森正在与Maruho有限公司（“Maruho”）合作开展CANDIN的临床开发计划。Maruho还计划在日本将CANDIN商业化。。

“The first patient treated with CANDIN represents a major milestone for the company, and for patients affected by common warts around the world,” said David P. Burney, PhD, MBA, President and Chief Operating Officer at Nielsen BioSciences. “We are proud of this new phase in our continuous effort to develop this new therapy and make it available to a patient population with high unmet need.”.

尼尔森生物科学公司（Nielsen BioSciences）总裁兼首席运营官、MBA博士大卫·P·伯尼（David P.Burney）表示：“第一位接受坎丁治疗的患者代表了该公司以及世界各地受寻常疣影响的患者的一个重要里程碑。”。“我们为这一新阶段感到骄傲，我们不断努力开发这种新疗法，并将其提供给需求未得到满足的患者群体。”。

Verruca vulgaris are benign lesions caused by infection of the skin with the human papillomavirus (HPV). They are raised lesions on the skin, commonly on the fingers, palms, knees, and soles of the feet. Since warts are caused by a viral infection, skin symptoms can be widespread and refractory. Common warts are estimated to affect approximately 10 percent of the global population.1 There are currently no FDA-approved prescription treatments..

寻常疣是由人乳头瘤病毒（HPV）感染皮肤引起的良性病变。它们是皮肤上隆起的病变，通常位于手指，手掌，膝盖和脚底。由于疣是由病毒感染引起的，因此皮肤症状可能广泛且难治。据估计，普通疣会影响全球约10%的人口。1目前还没有FDA批准的处方疗法。。

“We are in dire need of new therapies for wart treatment. I am excited about this trial and the potential to provide patients with an alternative to standard wart removal via acid, surgery, cryotherapy and other methods that can damage skin,” said Sandra Johnson, MD, FAAD, Dermatologist from Fort Smith Arkansas and one of the principal investigators of this clinical trial..

阿肯色州史密斯堡皮肤科医生、该临床试验的主要研究者之一、FAAD医学博士桑德拉·约翰逊（SandraJohnson）说：“我们迫切需要新的疣治疗方法。我对这项试验感到兴奋，并有可能通过酸、手术、冷冻疗法和其他可能损害皮肤的方法为患者提供标准疣切除的替代方案。”。。

About the Study

关于这项研究

The study is a phase 3, randomized, double-blind, placebo-controlled study of the safety and efficacy of CANDIN (Candida albicans Skin Test Antigen for Cellular Hypersensitivity) for the treatment of common warts (Verruca vulgaris) in adolescents and adults. The goal of the clinical trial is to compare outcome in healthy subjects 12 years of age and older with at least 3, but no more than 20, common warts (Verruca vulgaris) following treatment with CANDIN or placebo.

这项研究是一项关于CANDIN（白色念珠菌皮肤试验细胞超敏抗原）治疗青少年和成人常见疣（寻常疣）的安全性和有效性的3期随机双盲安慰剂对照研究。该临床试验的目的是比较12岁及以上的健康受试者与坎丁或安慰剂治疗后至少3个但不超过20个普通疣（寻常疣）的结果。

For more information, please see the study details at ClinicalTrials.gov..

有关更多信息，请参阅ClinicalTrials.gov上的研究详细信息。。

About Nielsen BioSciences

关于尼尔森生物科学

Nielsen BioSciences, Inc. is a privately-held, San Diego-based biopharmaceutical company focused on developing and commercializing biological products with wide-ranging applications in cell-mediated immune responses. For more information, please visit https://nielsenbio.com/about-us/.

尼尔森生物科学公司是一家总部位于圣地亚哥的私营生物制药公司，专注于开发和商业化生物产品，在细胞介导的免疫反应中具有广泛的应用。有关更多信息，请访问https://nielsenbio.com/about-us/.

About CANDIN

关于坎丁

CANDIN (Candida albicans Skin Test Antigen for Cellular Immunity) (“CANDIN”) is currently marketed in the United States for its U.S. Food and Drug Administration-approved use as a skin test antigen for the assessment of cellular hypersensitivity to Candida albicans. CANDIN is not currently approved in the United States or Japan for the treatment of Verruca vulgaris or any other indications.

CANDIN（用于细胞免疫的白色念珠菌皮肤试验抗原）（“CANDIN”）目前在美国上市，用于其美国食品和药物管理局批准用作皮肤试验抗原，用于评估白色念珠菌的细胞超敏反应。CANDIN目前在美国或日本尚未被批准用于治疗寻常疣或任何其他适应症。

In the United States, Nielsen previously completed a Phase II clinical trial investigating CANDIN in the treatment of human papillomavirus (HPV) conditions, including Verruca vulgaris..

在美国，尼尔森之前完成了一项II期临床试验，研究坎丁治疗人乳头瘤病毒（HPV）疾病，包括寻常疣。。

About Maruho

关于Maruho

Maruho Co., Ltd. has its headquarters in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,566 employees (as of the end of September 2023), and net sales were approximately 85.71 billion yen in its fiscal year ending September 30, 2023.

Maruho Co.，Ltd.总部位于大阪，在皮肤病产品的研发、制造和商业化方面处于日本领先地位。Maruho成立于1915年，拥有1566名员工（截至2023年9月底），截至2023年9月30日的财年净销售额约为857.1亿日元。

With the mission 'More smiles, brighter life for you.', Maruho aims to help realize a society where everyone can live with a smile. For more information, please visit https://www.maruho.co.jp/english/.

以“更多的微笑，为你带来更美好的生活”为使命，Maruho旨在帮助实现一个人人都可以微笑生活的社会。有关更多信息，请访问https://www.maruho.co.jp/english/.

1 Wart – StatPearls – NCBI Bookshelf (nih.gov), Accessed on May 5, 2023.

1 Wart–StatPearls–NCBI书架（nih.gov），2023年5月5日访问。