Nielsen Begins Phase 3 Trial for CANDIN Wart Treatment

Nielsen BioSciences, a San Diego-based biopharmaceutical firm, has initiated a pivotal Phase 3 clinical trial, CFW-3A, to assess the safety and effectiveness of CANDIN® in treating Verruca vulgaris, commonly known as common warts. The trial marks a significant step in addressing a prevalent condition with limited FDA-approved treatments. The study is designed to be double-blind and placebo-controlled, involving participants from the U.S. and Japan, reflecting Nielsen's commitment to global healthcare solutions.

David P. Burney, President and COO of Nielsen BioSciences, expressed pride in reaching this stage, highlighting the company's dedication to developing innovative therapies for patients with significant unmet medical needs. Common warts, caused by the human papillomavirus (HPV), are a widespread issue affecting approximately 10% of the world's population. These benign skin lesions often occur on the fingers, palms, knees, and soles and can be challenging to treat, with current methods including acid application, surgery, and cryotherapy, which may cause skin damage.

Sandra Johnson, MD, a dermatologist and principal investigator of the trial, emphasized the urgent need for new wart treatments and the potential of CANDIN to offer a less invasive alternative.

The Phase 3 study aims to evaluate the outcomes of CANDIN treatment in healthy individuals aged 12 and above with a specific range of common warts. CANDIN, a Candida albicans Skin Test Antigen, is currently used in the U.S. for assessing cellular hypersensitivity to Candida albicans and is not yet approved for treating warts or other conditions. Nielsen had previously conducted a Phase II trial investigating CANDIN's potential in treating HPV-related conditions.

Maruho Co., Ltd., a leading Japanese dermatological products company, is collaborating with Nielsen in the development and potential commercialization of CANDIN in Japan. Established in 1915, Maruho is dedicated to improving lives through its dermatological products, with a mission to bring more smiles and brighter lives to people.

Nielsen BioSciences is a privately-owned company specializing in the development and commercialization of biological products for cell-mediated immune responses. CANDIN's ongoing trial represents a significant advancement in the search for effective treatments for common warts, a condition that impacts a large portion of the global population and currently lacks FDA-approved prescription options.