Candida antigen(Nielsen BioSciences, Inc.)

Common warts are estimated to affect 10 percent of the global population Currently no FDA-approved prescription treatment for common warts Phase III patient enrollment expected to start in the second half of 2023 SAN FRANCISCO, June 14, 2023 /PRNewswire/ -- Vial, a global tech-driven CRO providing next-generation clinical trial management services, has partnered with Nielsen BioSciences, Inc. (Nielsen), a privately-held biopharmaceutical company based in San Diego, CA, to study the safety and efficacy of CANDIN® for the treatment of common warts. Nielsen focuses on developing and commercializing biological products with wide-ranging applications of cell-mediated immune responses. Vial will support Nielsen with their Phase III, randomized, double-blind, placebo-controlled clinical study of CANDIN for the treatment of Verruca vulgaris (common warts) in adolescents and adults in the U.S. and Japan. CANDIN is an approved diagnostic skin test and currently not approved by the FDA or Japan's Pharmaceuticals and Medical Devices Agency for the treatment of common warts. Vial's Dermatology CRO will work closely with the Nielsen Biosciences team through the completion of the Phase III clinical trial. "Vial is thrilled to collaborate with Nielsen on their Phase III clinical trial in the U.S. and Japan. We are committed to delivering high-quality trials powered by innovative technology that are affordable for sponsors. We have full confidence in our ability to drive optimal outcomes for this important study," said Wendy Pinson, Senior Director of Clinical Operations at Vial. Vial promises to deliver faster, more efficient trials for biotech sponsors at an affordable rate. Vial's Dermatology CRO distinguishes itself by leveraging digital technology, such as its Vial Technology Platform, combining eSource, EDC, and ePRO in one connected system to streamline site processes. Vial EDC is a modern, intuitive, and hyper-responsive EDC platform delivering a consumer-grade experience and next-generation performance to eClinical software. These best-in-class CRO services will accelerate the development of new therapies and devices for sponsors and patients. "Common warts are estimated to affect 10 percent of the global population but have no prescription-approved treatment. We look forward to partnering with the Vial team on CANDIN's Phase III clinical trial," said David P. Burney, Ph.D., MBA, President and COO at Nielsen BioSciences. "Our thoughtful discussion with their team, combined with an outstanding comprehensive presentation, gave us full confidence that this important clinical trial for common warts will be managed to the highest standards in the industry." 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. About Vial: Vial is a tech-enabled, next-generation CRO that promises faster and higher-quality execution of trials for less cost. The Vial Contract Research Organization (CRO) delivers on the promise of more efficient trials through its innovative technology platform that powers trials end-to-end from site startup to database lock. Vial's technology platform combines modern, intuitive eSource, EDC, and ePRO into one connected system, streamlining site processes and enabling considerable efficiencies. Vial operates across multiple Therapeutic Areas (Dermatology CRO, Ophthalmology CRO, Oncology CRO, Gastroenterology CRO, Neurology CRO, Cardiology CRO, Medical Device CRO, Rare Disease CRO, and Digital Therapeutics CRO). Vial is a San Francisco, California-based company with over 100+ employees. About Nielsen: Nielsen BioSciences, Inc. is a privately-held, San Diego-based biopharmaceutical company focused on developing products with wide-ranging applications of immune responses. For more information, please visit About CANDINⓇ:: CANDIN® (Candida albicans Skin Test Antigen for Cellular Immunity) ("CANDIN®") product 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. Neither CANDIN® nor the compound is currently approved in the United States or Japan for the treatment of Verruca vulgaris or any other indications. In the United States, Nielsen has completed a Phase II clinical trial investigating the compound in the treatment of human papillomavirus (HPV) conditions, including Verruca vulgaris. Nielsen has one United States Patent and one United States Patent Application, and ten Patent Applications outside the United States associated with its development and use of CANDINⓇ. Forward-Looking Statements This press release contains forward-looking statements regarding the development of a treatment for verruca vulgaris. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from our expectations and projections. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this press release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this press release. SOURCE Vial

Common warts are estimated to affect 10 percent of the global population Currently no FDA-approved prescription treatment Phase III patient enrollment expected to start in the second half of 2023 SAN DIEGO--(BUSINESS WIRE)-- Nielsen BioSciences, Inc. (“Nielsen”), a privately-held, San Diego-based biopharmaceutical company, today announced that it has entered into a license agreement with Maruho Co., Ltd. (“Maruho”), granting Maruho exclusive rights to market CANDINⓇ in Japan for the treatment of Verruca vulgaris (common warts). CANDIN is an approved diagnostic skin test and currently not approved by the FDA or Japan’s PMDA for the treatment of common warts. Enrollment in Nielsen’s phase III trial for common warts treatment is expected to begin in the second half of 2023. Under the terms of the license agreement, Nielsen grants Maruho an exclusive license for the post-launch sales and promotional activities of CANDIN in Japan after it is developed by Nielsen and approved by regulatory authorities. For the exclusive Japanese license, Maruho will pay Nielsen a substantial upfront payment, and additional development, regulatory and sales milestone payments based on outcomes. With the upfront payment and milestones, Nielsen has the potential to earn greater than $100 million from the license agreement with Maruho. Nielsen has one United States Patent and one United States Patent Application, as well as 10 Patent Applications outside the U.S., which is associated with its development and use of CANDIN. “Verruca vulgaris is not purely cosmetic in nature and can cause physical discomfort, bleeding, and psychological distress. It can also lead to other more serious conditions if left untreated. There is currently no FDA-approved prescription treatment,” said David P. Burney, PhD, MBA, President and COO at Nielsen BioSciences. “We are proud to continue the development of this potential new therapy and make it available to patients in need.” 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 10 percent of the global population.1 “This immunotherapy biologic holds great promise for providing patients with a non-invasive form of treatment for the millions of people who develop common warts yearly,” said H. Stewart Nielsen, Jr., Ph.D., Vice Chairman and Founder of Nielsen BioSciences. “The investigational treatment is given via an injection, which promises to be a potential improvement to standard removal of the wart via acid, surgery, cryotherapy and other methods that can damage skin.” Raymond James acted as the financial advisor to Nielsen on this transaction. About Nielsen 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 About CANDINⓇ CANDIN® (Candida albicans Skin Test Antigen for Cellular Immunity) (“CANDIN®”) product 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. Neither CANDIN® nor the compound is currently approved in the United States or Japan for the treatment of Verruca vulgaris or any other indications. In the United States, Nielsen has completed a Phase II clinical trial investigating the compound in the treatment of human papillomavirus (HPV) conditions, including Verruca vulgaris. Nielsen has one United States Patent and one United States Patent Application and ten Patent Applications outside the United States associated with its development and use of CANDINⓇ. About Maruho Maruho Co., Ltd. has its head office in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,547 employees (as of the end of September 2022), and net sales were approximately 85.67 billion yen in its fiscal year ended September 30, 2022. 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 Forward-Looking Statements This press release contains forward-looking statements regarding development of a treatment for Verruca vulgaris. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from our expectations and projections. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this press release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this press release. ____________________ 1 Wart - StatPearls - NCBI Bookshelf (nih.gov), Accessed on May 5, 2023.