CelAgace™ OraRinse Solution for Treatment of Candidiasis

CelAgace™ OraRinse (CAOR) Pilot Clinical Study for Management of Candidiasis Associated With Grade 0-II Mucositis

CelAgace™ OraRinse (silver citrate complex and acemannan) Solution is planned to be evaluated for safety and effectiveness as a potential treatment for candidiasis, a yeast infection, commonly known as thrush, which is associated with mouth sores.

CelAgace™ contains two active ingredients, a silver citrate complex salt (0.01mg/ml) that has demonstrated laboratory effectiveness against yeast organisms and acemannan (4.0mg/ml), a purified extract isolated from the inner leaf gel of the Aloe vera plant that has been used as a key ingredient in other oral care products. Patients will swish and spit the product 4 times daily (after meals and at bedtime) for 14 days. Following an initial office visit, patients will be evaluated on days 7 and 14 to determine response to the product.

Inclusion Criteria:

• Radiation induced oral mucositis with resulting candidiasis
• Chemotherapy induced oral mucositis with resulting candidiasis
• Oral mucositis due to being immunocompromised with resulting candidiasis
• Stomatitis due to other causes with resulting candidiasis
• Currently have mild to moderate mucositis

Exclusion Criteria:

Patient:

• under the age of 18
• pregnant or breastfeeding
• inability to use an oral rinse
• hypersensitivity to Aloe Vera and/or Silver
• whose candida rinse culture was performed greater than 10 days prior to study entry.
• has any sort of removable dental appliance
• with previous or current history of any cancer of the oral cavity
• who received therapy for candidiasis within the past 30 days
• who used antifungal medication in the last 30 days
• who has severe to life threatening oral muositis (Grade III-IV) oral mucositis
• with impaired renal or hepatic function
• receiving high dose chemotherapy and total body irradiation in preparation for Hemopoietic Stem Cell Transplant (HSCT) or Concomitant use of Kepivance® (palifermin or rhKGF)