Research & Development

CANDIN^® (Candida albicans skin test antigen for Cellular Hypersensivity) is in Phase 2 clinical studies for evaluation in the treatment of human papilloma virus (HPV) conditions including Verruca vulgaris or common warts. Approximately 20 million people are currently infected in the United States. Of the more than 40 HPV types that infect human mucosal surfaces, certain oncogenic types cause cervical cancer and other less common cancers. Other non-oncogenic HPV types can cause common warts, genital warts, plantar warts, flat warts, and, rarely, respiratory tract warts in children as a condition called juvenile-onset recurrent respiratory papillomatosis (RRP). CANDIN may provide an opportunity to leverage the body’s immune response to more effectively eliminate warts.

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

Leishmania Skin Test Antigen is made from the promastigote form of the parasite Leishmania. Phase 2 studies have been completed. Parasites of the genus Leishmania are found worldwide and cause the diseases of cutaneous or visceral leishmaniasis. The World Health Organization estimates there are 12 million cases of leishmaniasis from a population of 350 million at-risk individuals.

Veterinary Products
Nielsen BioSciences, Inc. is continuing to leverage its platform of diverse antigenic biologics in the diagnosis and prevention of important human and veterinary diseases. CANDIN^® has completed initial clinical veterinary trials for the treatment of canine and equine oral papilloma.

Information on our ongoing clinical trials can be seen at ClinicalTrials.gov
Use the key word “Nielsen BioSciences.”

INDICATION AND USAGE

CANDIN is a skin test antigen to assess cellular hypersensitivity to Candida albicans. CANDIN should not be used to diagnose or treat Type 1 allergy to Candida albicans.

IMPORTANT SAFETY INFORMATION FOR CANDIN:

WARNING:

The expected response to CANDIN 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.

CANDIN should never be given intravenously.

Contraindication:

CANDIN should not be used after a previous unacceptable adverse reaction to this antigen or to a similar product, i.e., extreme hypersensitivity/allergy.

Warnings and Precautions:

The antigen must be injected intradermally. Do not inject intravenously.

As has been observed with other, unstandardized, antigens used for DTH skin testing, it is possible that some patients may have exquisite immediate hypersensitivity to CANDIN.

Physicians using this product must have facilities, equipment and medication necessary to treat potential side effects. Epinephrine and oxygen must be immediately available in the event of a serious systemic response.

Adverse Reactions:

Immediate hypersensitivity local reactions can include itching, swelling, pain and blistering at the test site occurring 15-20 minutes after administration. Necrosis is possible.

Systemic reactions to CANDIN have not been observed, however all foreign antigens have the remote possibility of causing Type 1 anaphylaxis and even death when injected intradermally.

Drug Interactions:

Pharmacologic doses of corticosteroids may variably suppress the DTH skin test response after two weeks of therapy.

Patients receiving beta-blocking drugs may be refractive to the usual dose of epinephrine, in the event that epinephrine is required to control an adverse allergic reaction

Use in Specific Populations:

It is not known whether CANDIN can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. CANDIN should be given to pregnant women only if clearly needed.

It is not known whether CANDIN is excreted in human milk. Caution should be exercised when administered to a nursing woman.

Use in pediatric populations has not been established.

Geriatric populations may have a diminished response to the skin test.This Important Safety Information does not contain all the information needed to use CANDIN safely and effective. Please see Full Prescribing Information for additional information.