325 subjects enrolled across the United States and Japan in the first Phase III clinical trial for the treatment of warts in children and adults.
Results from the CFW-3A trial are expected by the end of 2025.
SAN DIEGO--(BUSINESS WIRE)--Nielsen BioSciences, Inc. (“Nielsen”), a privately-held, San Diego-based biopharmaceutical company, announced the final patient has been successfully enrolled in CFW-3A – 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. CANDIN is not currently approved for the treatment of common warts.
“I am pleased that the study accomplished this important milestone. Candida albicans has been well studied, but this is the first time that a randomized controlled Phase 3 clinical study to investigate safety, efficacy and optimal dosing for the treatment of warts has been conducted,” said Sandra Johnson, MD, FAAD, Dermatologist from Fort Smith Arkansas and one of the principal investigators of this clinical trial. “We look forward to the conclusion and analysis of this data to hopefully improve the treatment of common warts in adolescents and adults.”
“Warts are a cutaneous manifestation of human papilloma virus (HPV) infection. Therefore, an immunological therapy directed at eliminating the viral infection has the potential to be an improvement to removal of the wart versus acid, surgery, cryotherapy and other methods that can damage skin,” said H. Stewart Nielsen, Jr., Ph.D., Vice Chairman and Founder of Nielsen.
During the trial, participants will receive an injection of either Nielsen’s purified candida antigen (CANDIN) or a placebo every two weeks until either clinical clearance of the treatment wart is achieved, or a total of 10 injections have been administered. The primary endpoint of the trial is complete resolution of the treatment wart without recurrence at week 12. Results are expected by the end of 2025.
Nielsen is planning regulatory submissions in the US following the successful conclusion of the trial and has partnered with Maruho Co., Ltd. for the regulatory submission and commercialization of CANDIN in Japan. Nielsen is currently evaluating options and engaging in partnership discussions for commercialization in the US and other geographies.
About the Study
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. For more information, please see the study details at ClinicalTrials.gov.
About Nielsen BioSciences
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 www.nielsenbio.com
About CANDIN
CANDIN (Candida albicans Skin Test Antigen for Cellular Hypersensitivity (“CANDIN”) is currently licensed 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.
About 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 1,620 employees (as of the end of September 2024), and net sales were approximately 86.98 billion yen in its fiscal year ending September 30, 2024. 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/
Contacts
Nielsen BioSciences Contact Information:
Rachel Ford Hutman
Rachel@fordhutmanmedia.com
+1-301-801-5540
