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

A Single-Center, Open-Label, Pilot Study to Evaluate the 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).

Study Overview

• Status: Withdrawn
• Conditions: Vulvovaginitis; Candidiasis, Vulvovaginal; Vulvovaginal Candidiases; Yeast Infection; Yeast Infection Vaginal
• Intervention / Treatment: Drug: Oral Encochleated Amphotericin B (CAMB)

Detailed Description

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Tolan Park Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAMB 200 mg; 200 mg CAMB Oral Amphotericin B	Drug: Oral Encochleated Amphotericin B (CAMB); Lipid-crystal nano-particle formulation amphotericin B; Other Names: MAT2203
Experimental: CAMB 400 mg; 400 mg CAMB Oral Amphotericin B	Drug: Oral Encochleated Amphotericin B (CAMB); Lipid-crystal nano-particle formulation amphotericin B; Other Names: MAT2203

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects with clinical cure at the Test of Cure visit	Resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment	28 days
The proportion of subjects with mycological eradication at the Test of Cure visit	Negative culture for growth of baseline Candida	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment emergent adverse events	Safety assessments include laboratory assessments, vital signs and physical exam	28 days

Collaborators and Investigators

• Sponsor: Matinas BioPharma Nanotechnologies, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: fluconazole; fluconazole-resistant
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Infections; Communicable Diseases; Candidiasis; Mycoses; Vulvovaginitis; Candidiasis, Vulvovaginal; Anti-Infective Agents; Anti-Bacterial Agents; Antifungal Agents; Antiprotozoal Agents; Antiparasitic Agents; Amebicides; Amphotericin B; Liposomal amphotericin B
• Other Study ID Numbers: MB-70008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No