Clinical and Regulatory Development of Antibiofilm Drugs: The Need, the Potential, and the Challenges - Antibiofilm Agents: From Diagnosis to Treatment and Prevention - page 471

models of sinusitis
conducted by two
independent investi-
gator groups

Toltec Pharmaceuti-
cals (No website)

TOL-463 Undisclosed Phase I completed Antibiofilm activity dem-

onstrated in vitro
employing biofilm
model established by
the CDC (company
communication)

Vaginitis

University of British
Columbia http://
www.ubc.ca

Esp protein Esp protein from

S. epidermidis

Phase 1, not yet recruiting
(as per clinicaltrials.
gov, accessed October
31, 2013)

Biofilm endpoint in clini-
cal trial protocol on
clinicaltrials.gov and
peer-reviewed
publications

Chronic wound biofilms

ClinicalTrials.gov Identi-
fier: NCT016465502
a Multiple sources were surveyed for antibiofilm evidence including clinical trials.gov website, company websites, press releases, scientific publications, and
general Internet searches. All company websites were most recently accessed on 31 October 2013. Company sponsored agents with minimal or no indication
on the company website of intent to develop the drug as an antibiofilm agent, or where information was very dated, generally were not included except in cases
where the drug candidate was the subject of recent peer-reviewed publications demonstrating antibiofilm activity
b Catholic University of the Sacred Heart clinical study phase and status is unclear. The H. pylori study with a biofilm endpoint has not been updated on
clinicaltrials.gov since January 2010. Other more recent studies targeting other infectious diseases are listed but without mention of a biofilm endpoint
c In addition to Catholic University of the Sacred Heart, other clinical trials of NAC with biofilm endpoints (clinicaltrial.gov, accessed October 31, 2013) are
also being sponsored by Buddhist Tsu Chi General Hospital, Taiwan for H. pylori infections (NAC in combination with standard triple therapy, ClinicalTrials.
gov Identifier: NCT01572597, status: recruiting) and by Minia University, Egypt, for bacterial vaginosis (NAC alone or in combination with metronidazole,
ClinicalTrials.gov Identifier: NCT01841411, status: recruiting)