A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy

Inclusion Criteria:

- A serum HCV RNA level of >100,000 IU/ml using a quantitative, branched-chain-DNA
(bDNA)-based assay (lower limit of quantitation = ~650 IU/ml) or other equally
sensitive quantitative methods.

- Infection with genotype 1 HCV

- Documented failure to respond to treatment (defined as a patient who did not achieve
an early viral response (EVR) (≥2 log reduction in serum HCV RNA or undetectable HCV
RNA after 12 weeks of treatment) OR is serum HCV RNA positive after 24 weeks of
treatment with pegylated interferon plus ribavirin for hepatitis C

- Adequate laboratory parameters

- Women of childbearing potential willing to use two acceptable methods of birth control
during trial participation or are sterile or post-menopausal (defined as not having a
menstrual cycle for greater than two years)

- Sexually active male subjects are practicing acceptable methods of contraception
during trial participation

- Have the ability to understand the requirements of the trial, have provided written
informed consent, and agree to abide by the trial restrictions and to return for the
required assessments

- The subject must be able to self administer daily subcutaneous injections or their
caregiver must be able to administer daily subcutaneous injections

Exclusion Criteria:

- Clinical, laboratory, or histological evidence of liver cirrhosis

- Evidence of hepatic decompensation (presence of or a history of ascites, hepatic
encephalopathy, variceal bleeding, or hepatocellular carcinoma)

- Co-infection with human immunodeficiency virus (HIV) or active hepatitis B virus (HBV)
(as determined by presence of hepatitis B surface antigen (HBsAg)

- Have received pegylated interferon and/or ribavirin within the 60 days prior to
enrollment

- Any known preexisting medical condition that could interfere with the subject's
participation in and completion of the protocol

- Pregnant female or nursing mother