Phase II clinical trial results presented at the American Academy of Dermatology 2019 Annual Meeting

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.

David P. Burney, Ph.D., MBA new President and Chief Operating Officer of Nielsen Biosciences

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’ SPHERUSOL® Valley Fever Test Incorporated into Medicare Payment for Coccidioidomycosis Skin Test

/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’ SPHERUSOL Provides Physicians with New Test for Valley Fever

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.