The study represents a potential breakthrough in the treatment of common warts

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. 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.

“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.”

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.

“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.

 

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 https://nielsenbio.com/about-us/.

 

About CANDIN

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. 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.

 

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 1,566 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. 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/

 

Nielsen Bio Contact Information:
Rachel Ford Hutman
Rachel@fordhutmanmedia.com
+1-301-801-5540

 

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

• 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, May 16, 2023 – 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 https://nielsenbio.com/about-us/

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 https://www.maruho.co.jp/english/

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.

Contact Information:

Nielsen BioSciences, Inc.
11125 Flintkote Ave, Suite G
San Diego, CA 92121

For Medical or Clinical Information, contact:
David P. Burney, President & COO
Tel: 858-571-2726 Fax: 858-571-2759
medinfo@nielsenbio.com

For Corporate Development Inquiries, contact:
David E. Thomas Jr., Chairman
727-542-3200
Dave.Thomas@HillRiverCapital.com

For Media Inquiries, contact:
Rachel Ford Hutman
Rachel@fordhutmanmedia.com
+1-301-801-5540

 

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

Dr. Stacy R. Smith presented an abstract entitled – “Successful Treatment of Common Warts with Candida Extract – a Phase II study” at the Annual Meeting of the American Academy of Dermatology in Washington DC. Read More –

Candida albicans Skin Test Antigen for Cellular Hypersensitivity has not been proven safe and effective for use in warts.  Nielsen BioSciences intends to pursue FDA approval in the near future.

Nielsen BioSciences, Inc., a privately held biopharmaceutical company based in San Diego, announces the appointment of David P. Burney, Ph.D., MBA as President and Chief Operating Officer, effective October 15, 2017. Dr. Burney joins Nielsen BioSciences with more than 20 years’ executive experience in the pharmaceutical industry with specific experience in biologics manufacturing, quality and regulatory functions. Dr. Burney is familiar with Nielsen BioSciences having served as Vice President and Chief Operating Officer of Greer Laboratories, Inc., and having been a shareholder in Nielsen BioSciences since its spin-off from an affiliated entity of Greer Laboratories in 2013.

Dr. Burney has a proven track record of performance with extensive cGMP, FDA and compliance experience in biologics and sterile products. Most recently, he served as Vice President of Quality Operations at Biotest Pharmaceutical Corp. in Boca Raton, Florida, where he managed all aspects of quality for a manufacturer of plasma derived biological sterile drugs. In prior experience at Greer Laboratories, he managed the Quality, Manufacturing and Regulatory Affairs Departments for allergenic extracts. Dr. Burney holds a Ph.D. in Chemistry from the University of Memphis and an MBA from Ashland University.

Speaking on behalf of Nielsen BioSciences’ Board of Directors, David E. Thomas, Chairman, said: “We are delighted to welcome Dr. Burney aboard. The entire Nielsen Board of Directors is very familiar with David. He served our predecessor companies, Greer Laboratories and Allermed, as a senior executive since 2010. We believe his prior experience and deep understanding of our industry and our business will continue to enhance Nielsen BioSciences’ core competencies of developing and commercializing antigen-based products.”

“I have known and followed Nielsen BioSciences since its inception and am excited to join the team as President and COO. I am enthusiastic about the opportunities to build upon the current accomplishments and to continue to grow the business,” said Burney.  

Nielsen BioSciences, Inc. a FDA-licensed manufacturer moves its corporate headquarters to Flintkote Avenue in the center of Sorrento Valley, a major hub for the BioTech industry in San Diego. Nielsen occupies 7,600 square feet of state of the art mixed use laboratory and office space at its new location.

/PRNewswire/ — Nielsen BioSciences announced today that the Centers for Medicare & Medicaid Services (CMS) updated the payment rate for the coccidioidomycosis skin test to recognize the cost of SPHERUSOL® (Coccidioides immitis Spherule-Derived Skin Test Antigen).  The skin test is used in patients with Valley Fever.

“CMS’ decision to update the reimbursement rate for the coccidioidomycosis skin test will support access to the critical information SPHERUSOL provides to help manage this devastating disease, Valley Fever,” said Tom Carpenter, DVM, Ph.D., president and chief operating officer of Nielsen BioSciences. “SPHERUSOL can aid physician assessments about how the patient’s immune system is fighting the disease, information that they otherwise would not be able to attain from other commercially available tests for Valley Fever. We are pleased to see the decision by CMS, which will enable physicians to get appropriate reimbursement when testing patients impacted by this serious disease.”

Valley Fever is a serious infection that usually affects the lungs and is caused by inhaling airborne spores of the Coccidioides fungus, which grows in dry desert soil of the western United States. According to the Centers for Disease Control and Prevention, of the estimated 150,000 people per year who become infected with the Valley Fever fungus, 40 percent will develop symptoms, including fever, cough, chest pain, headaches, weight loss, night sweats, lethargy, and/or rashes. In severe cases, the fungal infection spreads from the lungs to other parts of the body, such as the central nervous system (brain and spinal cord infection), skin, bones and joints, can have life-long consequences and be life-threatening.

CMS’ updated reimbursement rate for the coccidioidomycosis skin test is $70.58 per test under the CMS Medicare Physician Fee Schedule for 2016. The updated reimbursement rate went into effect at the beginning of January. The Medicare reimbursement rate is also an importance source of information that may be used by private insurers and state health care plans to determine their own rate of reimbursement.

The CMS Medicare Physician Fee Schedule for 2016 can be found here: https://www.gpo.gov/fdsys/pkg/FR-2015-11-16/html/2015-28005.htm

 

About SPHERUSOL

SPHERUSOL is a skin test antigen administered by heath care professionals and is indicated for the detection of delayed-type hypersensitivity to Coccidioides in individuals with a history of pulmonary coccidioidomycosis. SPHERUSOL is a commercially available test specifically designed to see if a patient’s cellular immune system is responding to the fungus (Coccidioides) that causes Valley Fever.

The safety and effectiveness of SPHERUSOL have not been established in pregnant and nursing women, the pediatric population, or individuals > 65 years of age. The use of SPHERUSOL to detect delayed-type hypersensitivity response in a general population with unknown exposure to Coccidioides has not been evaluated. Persons with acute or disseminated coccidioidomycosis may not develop a delayed-type hypersensitivity response to SPHERUSOL. Persons with immunodeficiency and a history of coccidioidomycosis may not develop a delayed-type hypersensitivity response to SPHERUSOL.

 

Boxed Warning

The expected response to SPHERUSOL is a local area of inflammation at the site of the skin test. The reaction is usually dime to quarter size reaching maximum diameter between 24 and 48 hours. Larger accelerated reactions can occur, which may require treatment with local cold compresses and anti-inflammatory medication. Systemic reactions can occur with skin test antigens and in certain individuals these reactions may be life-threatening or cause death. Emergency measures and personnel trained in their use should be immediately available. Patients should be observed for at least 20 minutes following the administration of a skin test. SPHERUSOL should never be given intravenously. 

 

Additional Safety Information

The most common side effects in clinical studies were itching, swelling, pain and ulceration at the site. Certain drugs that suppress the immune system, such as corticosteroids, can prevent a delayed-type hypersensitivity response to SPHERUSOL.

See www.nielsenbiosciences.com for full prescribing information.

 

About Nielsen BioSciences 

Nielsen BioSciences develops products to help in the evaluation, treatment, or prevention of immune-mediated diseases that can be missed by narrowly targeted diagnostic strategies. In addition to SPHERUSOL, Nielsen markets CANDIN® (Candida albicans skin test antigen for cellular immunity.) FDA-approved for detecting delayed-type hypersensitivity, CANDIN is also a drug candidate in ongoing investigational studies evaluating its use in the treatment of human papilloma virus (HPV) lesions. For more information, visit www.nielsenbiosciences.com.

Nielsen BioSciences announced today the launch of SPHERUSOL® (Coccidioides immitis Spherule-Derived Skin Test Antigen), a skin test that provides valuable data to physicians managing Valley Fever infections. SPHERUSOL has been approved by the U.S. Food and Drug Administration as the only skin test to detect an immune response to the fungus called Coccidioides, or “cocci,” in patients with history of the disease. Valley Fever is a serious infection that usually affects the lungs and is caused by inhaling airborne spores of the cocci fungus, which grows in dry desert soil of the western United States from Washington to Texas, with the bulk of cases occurring in Arizona and California. Until now, tests available to physicians for Valley Fever have been limited to blood tests, X-rays, cultures and biopsies, none of which provide information about the cellular immune response, which is comprised of disease-fighting cells responsible for overcoming the disease.

“SPHERUSOL fills critical gaps in the current testing of Valley Fever,” explained Tom Carpenter,  DVM, Ph.D., senior vice president and chief development officer of Nielsen BioSciences. “With SPHERUSOL now broadly available, physicians have access to an important new tool to further inform their treatment decisions and incorporate into their standard of care of patients with this fungal disease.” Of the estimated 150,000 people per year who become infected1 with the Valley Fever fungus, 40 percent will develop symptoms, including fever, cough, chest pain, headaches, night sweats, or rashes(2). Diagnosis is often delayed for months as symptoms can be confused with the flu or bacterial pneumonia. The average patient misses a month of work or school. In severe cases, the fungal infection spreads from the lungs to other parts of the body, such as the central nervous system (brain and spinal cord infection), skin, bones and joints, can have life-long consequences and be life-threatening3.

“The information SPHERUSOL provides is important for tracking patients’ active infections and is critical to determining the urgency of care required for each individual. Knowing a patient’s skin test status helps me in managing my patients with Valley Fever,” said pulmonologist and author Craig Rundbaken, D.O., F.A.C.O.I., F.C.C.P., founder of the Arizona Institute of Respiratory Medicine and Valley Fever Clinic, in Sun City West, AZ.

Introduction of a new test for Valley Fever was also noted by U.S. House Majority Leader Kevin McCarthy (R-CA) and U.S. House Representative David Schweikert (R-AZ), who serve as the co-chairs of the bipartisan Congressional Valley Fever Task Force and are from the two states where the disease is most prevalent.

“As new advancements are made, the fight against Valley Fever continues to move forward. We must continue to work to improve the way we treat and prevent this disease,” said Majority Leader McCarthy.

“Valley Fever has silently affected entire communities in the southwest, including our families, friends, and even our beloved pets,” said U.S. House of Representative David Schweikert. “I am honored to be working with both our local businesses and constituency to help expand our efforts.  I see new developments, such as the introduction of the Spherusol skin test, as vital steps forward in the fight against Valley Fever.”

While Valley Fever is viewed as a regional disease of the desert west, the impact on the lives and economies of the region is substantial. Nationally in 2013 as many people were reported diagnosed with Valley Fever as were with the better-known disease tuberculosis.(4)

 

About SPHERUSOL

SPHERUSOL is a skin test antigen indicated for the detection of delayed-type hypersensitivity to Coccidioides in individuals with a history of pulmonary coccidioidomycosis.

Until now, clinicians had no commercially available test to see if the patient’s cellular immune system is responding to the disease. Spherusol addresses this unmet need because it is specifically designed to test the response of these disease-fighting cells to Valley Fever.

The safety and effectiveness of SPHERUSOL have not been established in pregnant and nursing women, the pediatric population, or individuals > 65 years of age. The use of SPHERUSOL to detect delayed-type hypersensitivity response in a general population with unknown exposure to Coccidioides has not been evaluated. Persons with acute or disseminated coccidioidomycosis may not develop a delayed-type hypersensitivity response to SPHERUSOL. Persons with immunodeficiency and a history of coccidioidomycosis may not develop a delayed-type hypersensitivity response to
SPHERUSOL.

 

Boxed Warning

The expected response to SPHERUSOL is a local area of inflammation at the site of the skin test. The reaction is usually dime to quarter size reaching maximum diameter between 24 and 48 hours. Larger accelerated reactions can occur, which may require treatment with local cold compresses and anti- inflammatory medication.
Systemic reactions can occur with skin test antigens and in certain individuals these reactions may be life-threatening or cause death. Emergency measures and personnel trained in their use should be immediately available. Patients should be observed for at least 20 minutes following the administration of a skin test. SPHERUSOL should never be given intravenously.

 

Additional Safety Information

The most common side effects in clinical studies were itching, swelling, pain and ulceration at the site. Certain drugs that suppress the immune system, such as corticosteroids, can prevent a delayed-type hypersensitivity response to SPHERUSOL.

See www.nielsenbiosciences.comfor Full Prescribing Information.

 

About Nielsen BioSciences

Nielsen BioSciences is a privately held biotechnology company based in San Diego and founded in 2013. The company focuses on developing products with wide-ranging applications of immune responses, to help in the evaluation, treatment, or prevention of diseases that can be missed by narrowly  targeted strategies. In addition to SPHERUSOL, Nielsen markets CANDIN® (Candida albicans skin test antigen for cellular immunity). FDA-approved for detecting delayed-type hypersensitivity, CANDIN is also a drug candidate in ongoing investigational studies evaluating its use in the treatment of human papilloma virus (HPV) lesions.

For more information, visit www.nielsenbiosciences.com.

 

 

Notes
1.   “Valley Fever: Awareness Is Key.” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 27 June 2013. Web. 01 Apr. 2015.
2.   “Press Release.” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 28 Mar. 2013. Web. 01 Apr. 2015.
3.   Valdivia L., Nix D, Wright M, et al. Coccidioidomycosis as a common cause of community- acquired pneumonia. Emerg Infect Dis. 2006;12(6):958-962.
4.   “Valley Fever (Coccidioidomycosis) Statistics.” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 20 Nov. 2014. Web. 01 Apr. 2015; and “Fact  Sheet.” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 18 Dec. 2014. Web. 01 Apr. 2015.