CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension

This Bridging Extension is to determine if intravenous CD101 is safe [Day 45- 52 for subjects
with candidemia only, or Day 52- 59 for subjects with invasive candidiasis with or without
candidemia] and effective [Day 14 (± 1 day)] in the treatment of candidemia and/or invasive
candidiasis when compared to caspofungin (followed by oral fluconazole).

Inclusion Criteria:

- mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken
less than or equal to 96 hours before randomization (defined as: at least 1 blood
culture positive for Candida or positive test for Candida from a sponsor approved
rapid diagnostic test or positive gram stain for yeast or positive culture for Candida
spp. from a specimen obtained from a normally sterile site)

- willing to initiate or continue medical treatment to cure infections, including
receipt of antibiotics and surgical procedures, if required. Patients receiving only
medications and measures for comfort and not cure should not be enrolled.

- female subjects of child bearing potential <2 years post menopausal must agree to one
barrier method and one highly effective method of birth control or sexual abstinence.

- male subjects must be vasectomized, abstain from sexual intercourse, or agree to use
barrier contraception (condom with spermicide), and also agree not to donate sperm
from first dose of CD101 (Day 1) until 90 days following last administration of study
drug.

- willing and able to provide written informed consent. If the subject is unable to
consent for himself/herself, a legally acceptable representative must provide informed
consent on their behalf.

- presence of one or more systemic signs attributable to candidemia and/or invasive
candidiasis

Exclusion Criteria:

- Any of the following forms of IC:

1. Septic arthritis in a prosthetic joint (septic arthritis in a native joint is
allowed)

2. Osteomyelitis

3. Endocarditis or myocarditis

4. Meningitis, endophthalmitis, or any central nervous system infection

- neutropenia

- alanine aminotransferase or aspartate aminotransferase levels >10 fold the upper limit
of normal

- severe hepatic impairment in subjects with a history of chronic cirrhosis

- greater than 48 hours systemic antifungal treatment at approved doses to treat
candidemia

- pregnant females

- lactating females who are nursing

- known hypersensitivity to CD101, caspofungin, any echinocandin, or to any of their
excipients

- previous participation in this or any previous CD101 study

- recent use of an investigational medicinal product within 28 days of first dose of
study drug or presence of an investigational device at the time of screening

- Principal Investigator considers the subject should not participate

- presence of indwelling vascular catheter or device that cannot be removed and is
likely to be the source of candidemia