Research & Development at Nielsen Biosciences

The active ingredient in our CANDIN product, currently approved as a skin test antigen for the assessment of cellular hypersensitivity to Candida albicans, is currently under investigation for the treatment of Verruca vulgaris or common warts. The antigen in CANDIN is not currently approved for the treatment of common warts but we are exploring whether this biologic product may provide an opportunity to leverage the body’s immune response to more effectively address that condition. Nielsen BioSciences has initiated a Phase 3 clinical trial for evaluation in the treatment of human papilloma virus (HPV) conditions including Verruca vulgaris or common warts.

This program is investigational: CANDIN is not currently approved for the treatment of common warts.

Information on our ongoing clinical trials can be obtained at https://clinicaltrials.gov/search?term=NCT05889845

Results in Phase 2 research involving common and non-common warts among adults were highly encouraging, and we are now advancing clinical research into use of the antigen in common and non-common warts. Though not treated, Plantar, Periungual, Flat, Facial, and Genital warts were evaluated in the Phase 2 subjects.

In addition, based on the Phase 2 results and a significant body of peer reviewed publications, we plan to continue evaluating the Candin antigen active ingredient as a potential treatment for a variety of other viral dermatological conditions, including Molluscum Contagiosum, Plantar Warts, Periungual Warts, Flat Warts, Facial Warts, and Genital Warts

Drug Development Pipeline

Candin development chart

Diseases and Conditions

Common Warts – Common warts are caused by human papillomavirus (HPV) and affect several areas of the body, most commonly fingers and hands. Common warts can be transmitted by touch and can take as long as two to six months to develop after skin has been exposed to the virus. Lesions can cause pain, discomfort, itchiness and embarrassment for patients, which lead them to look for treatment. Common wart treatment today is dominated (70%+) by destructive therapies such as cryotherapy, salicylic acid, surgical removal and blistering agents which can painful and cause scarring.

warts

Molluscum Contagiosum – A contagious viral infection primarily affecting children which usually results in 15 to 30 round, firm lesions that persist an average of 13 months with some cases unresolved after 2+ years. Lack of approved therapy is considered a major unmet medical need. Most often physicians recommend waiting and watching, but the continued presence of these lesions can have significant impact on quality of life.

Molluscum Contagiosum

Plantar Warts – Hard, grainy growths that appear on the heels or balls of the feet. Plantar warts are caused by the human papillomavirus (HPV). These can become irritated and painful.

plantar warts

Genital Warts – Small, flesh-colored bumps or have a cauliflower-like appearance. In many cases, the warts are too small to be visible. This is one of the most common types of sexually transmitted infections. Also caused by the human papillomavirus (HPV).

genital warts

Publications

Significance of interferon gamma in the prediction of successful therapy of common warts by intralesional injection of Candida antigen – https://pubmed.ncbi.nlm.nih.gov/28791682/
Ahmad Nofal, Ayman Marei, Amin Amer, Hanaa Amen (2017)

Immunotherapy with intralesional Candida albicans antigen in resistant or recurrent warts: a study –
https://pubmed.ncbi.nlm.nih.gov/24082180/
Imran Majid, Saher Imran (2013)

Pulsed-dye laser versus intralesional Candida albicans antigen injection in treatment of genital warts –
https://pubmed.ncbi.nlm.nih.gov/30901065/
Eman Hamed Elmaadawy, Shaimaa Saeed Shams, Doaa Salah Hegab, Raghda Ahmed Zaki (2019)

Research & Development at Nielsen Biosciences

Drug Development Pipeline

Diseases and Conditions

Publications

Important Safety Information For CANDIN:

Indication and Usage:

Warning:

Contraindication:

Warnings and Precautions:

Adverse Reactions:

Drug Interactions:

Use in Specific Populations:

Important Safety Information For Spherusol: