Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis

This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB
dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).

Approximately 16 women with fluconazole-resistant VVC will be randomized to either 200 mg or
400 mg oral CAMB for 14 days. The primary objectives of this study are to assess the clinical
cure rate, mycology eradication and responder outcome. The secondary objective of this study
is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB.

Inclusion Criteria:

- Female 18-65 years

- Informed Consent

- Clinical diagnosis of fluconazole-resistant VVC

- Negative pregnancy test

- Vaginal pH ≤ 4.5

Exclusion Criteria:

- Intolerance or hypersensitivity to any amphotericin B (AMB) product or to azole
antifungal drugs

- Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal
infections requiring antifungal therapy

- Received antifungal treatment for VVC within past 10 days except fluconazole, subjects
must discontinue fluconazole after informed consent

- Has another cause or suspected cause of vulvovaginitis

- Has active HPV

- Has other urogenital infection

- Has other vaginal or vulvar condition that would confound interpretation of clinical
response

- Has significant laboratory abnormality at screening

- Has Type I diabetes, use of insulin, HbA1c>10

- Exposure to any investigational product within 30 days of screening

- Has other condition that would interfere with subject ability to provide informed
consent or put subject at undue risk