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GI-5005 · 2 trials · 2 indications
Early Virologic Response (EVR) is a response measured by the reduction of virus in the blood after 12 weeks of treatment.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | GI-5005 monotherapy continuing on to triple therapy |
| 2 | ACTIVE_COMPARATOR | Standard of care alone |
| Name | Type | Description |
|---|---|---|
| GI-5005 | DRUG | 40YU, subcutaneous |
| Pegylated Interferon and Ribavirin | DRUG | Pegylated interefron is an injection and ribavirin is an oral tablet |
Inclusion Criteria: * Chronic hepatitis C infection with genotype 1 based on serum positivity for HCV RNA or a positive test for serum anti-HCV antibody for at least 6 months; * One of the following response criteria based on response to prior combination therapy with pegylated or non-pegylated int...
GI-5005 is an investigational therapeutic vaccine being developed for the treatment of Genotype 1 Chronic Hepatitis C and Hepatitis C. It is designed to be used in patients with these infections, and it has been studied in clinical trials as a potential treatment option.
GI-5005 is being developed by ImmunityBio, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol IBRX on the stock market. ImmunityBio is responsible for the research and clinical development of this investigational therapeutic vaccine.
GI-5005 is in Phase 2 clinical development. It has completed a Phase 1 trial and a Phase 2 trial. The drug is still investigational and has not been approved by regulatory authorities. It is being studied for its safety and efficacy in treating chronic hepatitis C infection.
GI-5005 has been studied in two completed clinical trials. The Phase 1 trial, NCT00124215, evaluated the safety and efficacy of GI-5005 versus placebo in 48 patients with hepatitis C. The Phase 2 trial, NCT00606086, studied GI-5005 combined with standard of care therapy in 140 patients with Genotype 1 Chronic Hepatitis C.
GI-5005 is a therapeutic vaccine designed to treat chronic hepatitis C infection. While the specific molecular target is not disclosed, therapeutic vaccines work by stimulating the body's immune system to recognize and attack the virus. It is being studied in combination with standard antiviral therapy to enhance treatment response.
GI-5005 is a distinct investigational therapeutic vaccine, not the same as standard antiviral drugs used for hepatitis C. It has been studied in combination with pegylated interferon plus ribavirin, which is the standard of care, but GI-5005 itself is a separate experimental agent being developed by ImmunityBio.